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2. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan, Spicer, Jonathan D, Garassino, Marina C, Majem, Margarita, Martinengo, Gastón L, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, and Samkari, Ayman

Published
2024
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3. Checkpoint Inhibitor Monotherapy in Potentially Trial-Eligible or Trial-Ineligible Patients With Metastatic NSCLC in the German Prospective CRISP Registry Real-World Cohort (AIO-TRK-0315)

Author

Ababei, Juliana, Alt, Jürgen, Ammon, Andreas, Anhuf, Jürgen, Azeh, Ivo, Bauer, Stefan, Behringer, Dirk, Berger, Winfried, Bernhardt, Christiane, Bertram, Mathias, Boesche, Michael, Bohnet, Sabine, Bruch, Harald-Robert, Brückl, Wolfgang, Burkhard-Meier, Ulrike, Christopoulos, Petros, Däßler, Klaus-Ulrich, de Wit, Maike, Dechow, Tobias, Depenbusch, Reinhard, Dietze, Lutz, Dommach, Markus, Dörfel, Steffen, Eberhardt, Wilfried, Elender, Corinna, Elsel, Wolfgang, Emde, Till-Oliver, Faehling, Martin, Fietz, Thomas, Fischer, Jürgen R., Flieger, Dimitri, Freidt, Anke, Freier, Werner, Frenzel, Christian, Fuchs, Florian, Fuchs, Roswitha, Gaska, Tobias, Gleiber, Wolfgang, Grah, Christian, Griesinger, Frank, Grohé, Christian, Groschek, Matthias, Güldenzoph, Björn, Günther, Andreas, Haas, Siegfried, Hackenthal, Matthias, Hagen, Volker, Hahn, Lars, Hannig Carla, Verena, Hansen, Richard, Harich, Hanns-Detlev, Heilmann, Monika, Heinrich, Kathrin, Hering-Schubert, Christiane, Heßling, Jörg, Hoffknecht, Petra, Hortig, Patricia, Hübner, Gerdt, Hummel, Horst-Dieter, Hutzschenreuter, Ulrich, Illmer, Thomas, Innig, Georg, Jaeschke, Bastian, Junghanß, Christian, Kaiser, Ulrich, Kamal, Haytham, Kambartel, Kato, Kern, Jens, Kimmich, Martin, Kingreen, Dorothea, Kirchen, Heinz, Klausmann, Martine, Klein, Ortwin, Kokowski, Konrad, Körber, Wolfgang, Kortsik, Cornelius, Koschel, Dirk, Krämer, Benoit, Krammer-Steiner, Beate, Laack, Eckart, Lamberti, Christof, Leistner, Rumo David, Losem, Christoph, Lück, Andreas, Maintz, Christoph, Martin, Kerstin, Medgenberg, Dirk, Metzenmacher, Martin, Meyer zum Büschenfelde, Christian, Meyn, Philipp, Moorahrend, Enno, Müller, Annette, Müller, Lothar, Neise, Michael, Nückel, Holger, Nusch, Arnd, Overbeck, Tobias, Pelz, Henning, Petersen, Volker, Peuser, Bettina, Plath, Margarete, Randerath, Winfried J., Rauh, Jacqueline, Reck, Martin, Reichert, Dietmar, Reinmuth, Niels, Reiser, Marcel, Repp, Roland, Reschke, Daniel, Rittmeyer, Achim, Rodemer, Yolanda, Sackmann, Sandra, Sadjadian, Parvis, Sandner, Reiner, Sauer, Annette, Schäfer, Harald, Schaudt, Christoph, Schlag, Rudolf, Schmidt, Burkhard, Schmitz, Stephan, Schröder, Jan, Schroeder, Michael, Schulze, Mathias, Schumann, Christian, Schütte, Wolfgang, Schwaiblmair, Martin, Schwindt Peter, Florian, Sebastian, Martin, Seese, Bernd, Seipelt, Gernot, Sorgenfrei, Thomas, Steiff, Johannes, Steiniger, Heike, Trarbach, Tanja, Tufman, Amanda, Uhlig, Jens, Vehling-Kaiser, Ursula, von der Heyde, Eyck, von Verschuer, Ulla, Waller, Cornelius, Wehler, Thomas, Weißenborn, Georg, Weißinger, Florian, Wermke, Martin, Wesseler, Claas, Wiegand, Jörg, Wilhelm, Stefan, Wilke, Jochen, Zahn, Mark-Oliver, Zaiss, Matthias, Zeth, Matthias, Eberhardt, Wilfried E.E., Brueckl, Wolfgang M., Jänicke, Martina, Fleitz, Annette, Zacharias, Stefan, Hipper, Annette, Groth, Annika, Weichert, Wilko, and Thomas, Michael

Published
2024
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5. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, and Zurawski, Bogdan

Abstract

At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.

Published
2024
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7. ADJUBIL: A phase II study of immunotherapy with durvalumab and tremelimumab in combination with capecitabine or without capecitabine in adjuvant situation for biliary tract cancer.

Author

Goetze, Thorsten, primary, Eickhoff, Regina, additional, Pons, Miriam, additional, Kochen, Lisa, additional, Vortmeyer, Doerthe, additional, Al-Batran, Salah-Eddin, additional, Habibzade, Timursah, additional, Adler, Marius, additional, Gonzalez-Carmona, Maria A, additional, Ettrich, Thomas Jens, additional, Koehne, Claus-Henning, additional, Pink, Daniel, additional, van Boemmel, Florian, additional, Pession, Ursula, additional, Wehler, Thomas, additional, and Modest, Dominik Paul, additional

Published
2024
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9. Structure-Based Discovery of Small Molecules Binding to RNA

Author

Wehler, Thomas, Brenk, Ruth, Bernstein, Peter R., Series editor, Georg, Gunda I., Series editor, Keller, Thomas, Series editor, Kobayashi, Toshi, Series editor, Lowe, John A., Series editor, Meanwell, Nicholas A., Series editor, Saxena, Anil Kumar, Series editor, Stilz, Ulrich, Series editor, Supuran, Claudiu T., Series editor, Zhang, Ao, Series editor, and Garner, Amanda L., editor

Published
2018
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11. Supplementary Figure 1 from Superior Antitumor In vitro Responses of Allogeneic Matched Sibling Compared with Autologous Patient CD8+ T Cells

Author

Kausche, Sandra, primary, Wehler, Thomas, primary, Schnürer, Elke, primary, Lennerz, Volker, primary, Brenner, Walburgis, primary, Melchior, Sebastian, primary, Gröne, Mark, primary, Nonn, Marion, primary, Strand, Susanne, primary, Meyer, Ralf, primary, Ranieri, Elena, primary, Huber, Christoph, primary, Falk, Christine S., primary, and Herr, Wolfgang, primary

Published
2023
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12. Supplementary Figure 2 from Superior Antitumor In vitro Responses of Allogeneic Matched Sibling Compared with Autologous Patient CD8+ T Cells

Author

Kausche, Sandra, primary, Wehler, Thomas, primary, Schnürer, Elke, primary, Lennerz, Volker, primary, Brenner, Walburgis, primary, Melchior, Sebastian, primary, Gröne, Mark, primary, Nonn, Marion, primary, Strand, Susanne, primary, Meyer, Ralf, primary, Ranieri, Elena, primary, Huber, Christoph, primary, Falk, Christine S., primary, and Herr, Wolfgang, primary

Published
2023
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13. Supplementary Figure Legends 1-2 from Superior Antitumor In vitro Responses of Allogeneic Matched Sibling Compared with Autologous Patient CD8+ T Cells

Author

Kausche, Sandra, primary, Wehler, Thomas, primary, Schnürer, Elke, primary, Lennerz, Volker, primary, Brenner, Walburgis, primary, Melchior, Sebastian, primary, Gröne, Mark, primary, Nonn, Marion, primary, Strand, Susanne, primary, Meyer, Ralf, primary, Ranieri, Elena, primary, Huber, Christoph, primary, Falk, Christine S., primary, and Herr, Wolfgang, primary

Published
2023
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14. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial

Author

Ignatius Ou, SaiHong, Planchard, David, Park, Keunchil, Schuler, Martin, Yang, James, Chand, Vikram, Rohr, Klaus, Bagnes, Claudia, Martin, Claudio Marcelo, Recondo, Gonzalo, Zarba, Juan Jose, Blajman, Cesar, Richardet, Martín, McLachlan, Sue-Anne, Parente, Phillip, Underhill, Craig, Crombie, Catherine, Mainwaring, Paul, Greil, Richard, Humblet, Yves, Bustin, Frédérique, Carestia, Luciano, Galdermans, Danny, Lambrechts, Marc, Delval, Laetitia, Vercauter, Piet, Zhou, Caicun, Wang, Jin, Huang, Cheng, Lin, Xiaoyan, Wu, Yilong, Liu, Xiaoqing, Cheng, Ying, Qin, Shukui, Feng, Jifeng, Huang, Jianjin, Zhang, Yiping, Lu, Shun, Zereu, Manuela, Garicochea, Bernardo, Zadra, Cyntia Albuquerque, Riska, Henrik, Alanko, Tuomo, Cadranel, Jacques, Chouaid, Christos, Zalcman, Gérard, Sibilot, Denis Moro, Perol, Maurice, Bennouna, Jaafar, Fournel, Pierre, Gervais, Radj, Rotarski, Maciej, Coudert, Bruno, Thomas, Michael, Wehler, Thomas, Faehling, Martin, Keilholz, Ulrich, Laack, Eckart, von Pawel, Joachim, Huber, Rudolf, Dickgreber, Nicolas, Wiewrodt, Rainer, Mark, Zsuzsanna, Tehenes, Sandor, Strausz, Janos, Sarosi, Veronika, Prabhash, Kumar, Jain, Minish, Venkatesan, Srinivasan, Sharma, Lalit, Dadhich, Hemant, Nagarkar, Rajnish Vasant, Onn, Amir, Gottfried, Maya, Stemmer, Solomon, Migliorino, Maria Rita, Grossi, Francesco, Bidoli, Paolo, Bearz, Alessandra, Gridelli, Cesare, Milandri, Carlo, Platania, Marco, Ceresoli, Giovanni Luca, Cruciani, Giorgio, Delgado, Francisco Gutierrez, Gonzalez Perez, José Luis, Luna, Gabriela Alvarado, Baca, Othon Padilla, Aerts, J.G.J.V., Stigt, J.A., Dingemans, A.M.C., Herder, G.J.M., Gans, S.J.M., Salas Sánchez, Jorge Fernando, Alvarez Barreda, Renzo Luzgardo, Pantigoso, Wilbert Rodriguez, Palomino, Osbert Luis Mejia, Jaskiewicz, Piotr, Kazarnowicz, Andrzej, Serwatowski, Piotr, Szczesna, Aleksandra, Jassem, Jacek, Lubennikov, Vladimir, Karaseva, Nina, Orlov, Sergey, Ragulin, Yuri, Garrido, Pilar, González Larriba, José Luis, Camps, Carlos, Campelo, Rosario García, Lianes, Pilar, Cobo, Manuel, Felip, Enriqueta, Kim, Dong-Wan, Kim, Sang-We, Kim, Joo-Hang, Han, Ji-Youn, Kim, Young-Chul, Yang, Chih-Hsin, Hsia, Te-Chun, Chen, Yuh-Min, Tsai, Ying-Huang, Chang, Gee-Chen, Tsao, Thomas Chang-Yao, Su, Wu-Chou, Huang, Ming-Shyan, Ho, Ching-Liang, Hsieh, Ruey-Kuen, Vinnyk, Yuriy, Popovych, Oleksandr, Ponomarova, Olga, Bondarenko, Igor, Polishchuk, Iryna, Shah, Riyaz, Mitra, Sanka, Popat, Sanjaykumar, Spicer, James, Toy, Elizabeth, Talbot, Toby, Brown, Emma, Upadhyay, Sunil, Summers, Yvonne, Gurtler, Jayne, Meza, Luis, Thropay, John, Schuler, M., Yang, J.C.-H., Park, K., Kim, J.-H., Bennouna, J., Chen, Y.-M., Chouaid, C., De Marinis, F., Feng, J.-F., Grossi, F., Kim, D.-W., Liu, X., Lu, S., Strausz, J., Vinnyk, Y., Wiewrodt, R., Zhou, C., Wang, B., Chand, V.K., and Planchard, D.

Published
2016
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15. Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine M., Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Pless, Miklos, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Alt, Jürgen, Bischoff, Helge, Geißler, Michael, Griesinger, Frank, Kallen, Karl-Josef, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Hong, Henoch S., Koch, Sven D., Gnad-Vogt, Ulrike, and Zippelius, Alfred

Published
2019
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18. Nintedanib plus docetaxel after progression on first-line immunochemotherapy in patients with lung adenocarcinoma: Cohort C of the non-interventional study, VARGADO

Author

Grohé, Christian, primary, Wehler, Thomas, additional, Dechow, Tobias, additional, Henschke, Sven, additional, Schuette, Wolfgang, additional, Dittrich, Ina, additional, Hammerschmidt, Stefan, additional, Müller-Huesmann, Harald, additional, Schumann, Christian, additional, Krüger, Stefan, additional, Atz, Judith, additional, and Kaiser, Rolf, additional

Published
2022
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20. Quality of Life in NSCLC Survivors - A Multicenter Cross-Sectional Study

Author

Hechtner, Marlene, Eichler, Martin, Wehler, Beatrice, Buhl, Roland, Sebastian, Martin, Stratmann, Jan, Schmidberger, Heinz, Gohrbandt, Bernhard, Peuser, Jessica, Kortsik, Cornelius, Nestle, Ursula, Wiesemann, Sebastian, Wirtz, Hubert, Wehler, Thomas, Bals, Robert, Blettner, Maria, and Singer, Susanne

Subjects
Quality of life, Lung cancer, Survivor, Patient-reported outcome, Predictor
Published
2022
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21. Prognostic factors in non-small-cell lung cancer: insights from the German crisp registry

Author

Griesinger, Frank, Hummel, Horst-Dieter, Schäfer, Harald, de Wit, Maike, Kaiser, Ulrich, Kern, Jens, Jänicke, Martina, Spring, Lisa, Zacharias, Stefan, Kaiser-Osterhues, Anja, Groth, Annika, Hipper, Annette, Zaun, Gregor, Müller, Lothar, Uhlig, Jens, Thomas, Michael, Sebastian, Martin, Eberhardt, Wilfried, Ababei, Juliana, Alt, Jürgen, Ammon, Andreas, Anhuf, Jürgen, Azeh, Ivo, Bauer, Stefan, Behringer, Dirk, Berger, Winfried, Bernhardt, Christiane, Bertram, Mathias, Boesche, Michael, Bohnet, Sabine, Bruch, Harald-Robert, Brückl, Wolfgang, Burkhard-Meier, Ulrike, Christopoulos, Petros, Däßler, Klaus-Ulrich, Dechow, Tobias, Depenbusch, Reinhard, Dietze, Lutz, Dommach, Markus, Dörfel, Steffen, Elender, Corinna, Elsel, Wolfgang, Emde, Till-Oliver, Faehling, Martin, Fietz, Thomas, Fischer, Jürgen R., Flieger, Dimitri, Freidt, Anke, Freier, Werner, Frenzel, Christian, Fuchs, Florian, Fuchs, Roswitha, Gaska, Tobias, Gleiber, Wolfgang, Grah, Christian, Grohé, Christian, Groschek, Matthias, Güldenzoph, Björn, Günther, Andreas, Haas, Siegfried, Hackenthal, Matthias, Hagen, Volker, Hahn, Lars, Hannig, Carla Verena, Hansen, Richard, Harich, Hanns-Detlev, Heilmann, Monika, Heinrich, Kathrin, Hering-Schubert, Christiane, Heßling, Jörg, Hoffknecht, Petra, Hortig, Patricia, Hübner, Gerdt, Hutzschenreuter, Ulrich, Illmer, Thomas, Innig, Georg, Jaeschke, Bastian, Junghanß, Christian, Kamal, Haytham, Kambartel, Kato, Kimmich, Martin, Kingreen, Dorothea, Kirchen, Heinz, Klausmann, Martine, Klein, Ortwin, Kokowski, Konrad, Körber, Wolfgang, Kortsik, Cornelius, Koschel, Dirk, Krämer, Benoit, Krammer-Steiner, Beate, Laack, Eckart, Lamberti, Christof, Leistner, Rumo David, Losem, Christoph, Lück, Andreas, Maintz, Christoph, Martin, Kerstin, Medgenberg, Dirk, Metzenmacher, Martin, Meyer zum Büschenfelde, Christian, Meyn, Philipp, Moorahrend, Enno, Müller, Annette, Neise, Michael, Nückel, Holger, Nusch, Arnd, Overbeck, Tobias, Pelz, Henning, Petersen, Volker, Peuser, Bettina, Plath, Margarete, Randerath, Winfried J., Rauh, Jacqueline, Reck, Martin, Reichert, Dietmar, Reinmuth, Niels, Reiser, Marcel, Repp, Roland, Reschke, Daniel, Rittmeyer, Achim, Rodemer, Yolanda, Sackmann, Sandra, Sadjadian, Parvis, Sandner, Reiner, Sauer, Annette, Schaudt, Christoph, Schlag, Rudolf, Schmidt, Burkhard, Schmitz, Stephan, Schröder, Jan, Schroeder, Michael, Schulze, Mathias, Schumann, Christian, Schütte, Wolfgang, Schwaiblmair, Martin, Schwindt, Peter Florian, Seese, Bernd, Seipelt, Gernot, Sorgenfrei, Thomas, Steiff, Johannes, Steiniger, Heike, Trarbach, Tanja, Tufman, Amanda, Vehling-Kaiser, Ursula, von der Heyde, Eyck, von Verschuer, Ulla, Waller, Cornelius, Wehler, Thomas, Weißenborn, Georg, Weißinger, Florian, Wermke, Martin, Wesseler, Claas, Wiegand, Jörg, Wilhelm, Stefan, Wilke, Jochen, Zahn, Mark-Oliver, Zaiss, Matthias, and Zeth, Matthias

Subjects
Pulmonary and Respiratory Medicine, Medizin
Abstract

IntroductionUnderstanding prognosis, especially long-term outcome, in advanced nonsmall cell lung cancer (NSCLC) is crucial to inform patients, guide treatment and plan supportive and palliative care.MethodsPrognostic factors influencing overall survival (OS) and progression-free survival (PFS) in 2082 patients with wild-type (WT)-NSCLC (629 M1a, 249 M1b, 1204 M1c) are reported. Patients were included in the prospective German CRISP registry recruiting in >150 centres. Analysis for pre-therapeutic factors was based on results from Cox proportional hazard models.ResultsCurrent M-descriptors of the Union for International Cancer Control-8 staging system were validated: M1a and M1b patients had significantly longer median time to events compared to M1c (OS/PFS 16.4/7.2 months, 17.8/6.7 months and 10.9/5.4 months, respectively). OS and PFS were influenced by number and location of metastatic organ systems. M1c and four or more metastatic organs involved had shorter OS and PFS than M1c with one to three organs (OS hazard ratio (HR) 1.69, pConclusionIn this large observational dataset, we further defined factors for outcome in WT-NSCLC, including increased number of involved metastatic organ systems and liver metastases, as those with overall poorer prognosis and reduced survival chance.

Published
2022

22. Effect of performance status (ECOG PS) on treatment outcome with second-line (2L) nintedanib (NIN) + docetaxel (DOC) for patients (pts) with lung adenocarcinoma after first-line (1L) immune checkpoint inhibitor (ICI) combination therapy.

Author

Grohé, Christian, primary, Wehler, Thomas, additional, Henschke, Sven, additional, Dittrich, Ina, additional, Hammerschmidt, Stefan, additional, Aulmann, Christoph, additional, Dechow, Tobias, additional, Schiefer, Conrad, additional, Zander, Ingo, additional, Schuette, Wolfgang, additional, Atz, Judith, additional, and Kaiser, Rolf, additional

Published
2022
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23. Phase 3, randomized, placebo-controlled study of stereotactic body radiotherapy (SBRT) with or without pembrolizumab in patients with unresected stage I or II non–small cell lung cancer (NSCLC): KEYNOTE-867.

Author

Jabbour, Salma K., primary, Houghton, Baerin, additional, Robinson, Andrew George, additional, Quantin, Xavier, additional, Wehler, Thomas, additional, Kowalski, Dariusz, additional, Ahn, Myung-Ju, additional, Erman, Mustafa, additional, Giaccone, Giuseppe, additional, Borghaei, Hossein, additional, McLean, Jessica, additional, Xu, Yan, additional, Souza, Fabricio, additional, and Pall, Georg, additional

Published
2022
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24. Preclinical analyses and phase I evaluation of LY2603618 administered in combination with Pemetrexed and cisplatin in patients with advanced cancer

Author

Calvo, Emiliano, Chen, Victor J., Marshall, Mark, Ohnmacht, Ute, Hynes, Scott M., Kumm, Elizabeth, Diaz, H. Bruce, Barnard, Darlene, Merzoug, Farhana F., Huber, Lysiane, Kays, Lisa, Iversen, Philip, Calles, Antonio, Voss, Beatrice, Lin, Aimee Bence, Dickgreber, Nicolas, Wehler, Thomas, and Sebastian, Martin

Published
2014
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25. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial

Author

Schuler, M., Yang, J. C.-H., Park, K., Kim, J.-H., Bennouna, J., Chen, Y.-M., Chouaid, C., De Marinis, F., Feng, J.-F., Grossi, F., Kim, D.-W., Liu, X., Lu, S., Strausz, J., Vinnyk, Y., Wiewrodt, R., Zhou, C., Wang, B., Chand, V. K., Planchard, D., Ignatius Ou, Sai Hong, Planchard, David, Park, Keunchil, Schuler, Martin, Yang, James, Chand, Vikram, Rohr, Klaus, Bagnes, Claudia, Martin, Claudio Marcelo, Recondo, Gonzalo, Zarba, Juan Jose, Blajman, Cesar, Richardet, Martín, McLachlan, Sue-Anne, Parente, Phillip, Underhill, Craig, Crombie, Catherine, Mainwaring, Paul, Greil, Richard, Humblet, Yves, Bustin, Frédérique, Carestia, Luciano, Galdermans, Danny, Lambrechts, Marc, Delval, Laetitia, Vercauter, Piet, Zhou, Caicun, Wang, Jin, Huang, Cheng, Lin, Xiaoyan, Wu, Yilong, Liu, Xiaoqing, Cheng, Ying, Qin, Shukui, Feng, Jifeng, Huang, Jianjin, Zhang, Yiping, Lu, Shun, Zereu, Manuela, Garicochea, Bernardo, Zadra, Cyntia Albuquerque, Riska, Henrik, Alanko, Tuomo, Cadranel, Jacques, Chouaid, Christos, Zalcman, Gérard, Sibilot, Denis Moro, Perol, Maurice, Planchard, David, Bennouna, Jaafar, Fournel, Pierre, Gervais, Radj, Rotarski, Maciej, Coudert, Bruno, Schuler, Martin, Thomas, Michael, Wehler, Thomas, Faehling, Martin, Keilholz, Ulrich, Laack, Eckart, von Pawel, Joachim, Huber, Rudolf, Dickgreber, Nicolas, Wiewrodt, Rainer, Mark, Zsuzsanna, Tehenes, Sandor, Strausz, Janos, Sarosi, Veronika, Prabhash, Kumar, Jain, Minish, Venkatesan, Srinivasan, Sharma, Lalit, Dadhich, Hemant, Nagarkar, Rajnish Vasant, Onn, Amir, Gottfried, Maya, Stemmer, Solomon, Migliorino, Maria Rita, Grossi, Francesco, Bidoli, Paolo, Bearz, Alessandra, Gridelli, Cesare, Milandri, Carlo, Platania, Marco, Ceresoli, Giovanni Luca, Cruciani, Giorgio, Delgado, Francisco Gutierrez, Gonzalez Perez, José Luis, Luna, Gabriela Alvarado, Baca, Othon Padilla, Aerts, J.G.J.V., Stigt, J.A., Dingemans, A.M.C., Herder, G.J.M., Gans, S. J. M., Salas Sánchez, Jorge Fernando, Alvarez Barreda, Renzo Luzgardo, Pantigoso, Wilbert Rodriguez, Palomino, Osbert Luis Mejia, Jaskiewicz, Piotr, Kazarnowicz, Andrzej, Serwatowski, Piotr, Szczesna, Aleksandra, Jassem, Jacek, Lubennikov, Vladimir, Karaseva, Nina, Orlov, Sergey, Ragulin, Yuri, Garrido, Pilar, González Larriba, José Luis, Camps, Carlos, Campelo, Rosario García, Lianes, Pilar, Cobo, Manuel, Felip, Enriqueta, Kim, Dong-Wan, Kim, Sang-We, Park, Keunchil, Kim, Joo-Hang, Han, Ji-Youn, Kim, Young-Chul, Yang, Chih-Hsin, Hsia, Te-Chun, Chen, Yuh-Min, Tsai, Ying-Huang, Chang, Gee-Chen, Tsao, Thomas Chang-Yao, Su, Wu-Chou, Huang, Ming-Shyan, Ho, Ching-Liang, Hsieh, Ruey-Kuen, Vinnyk, Yuriy, Popovych, Oleksandr, Ponomarova, Olga, Bondarenko, Igor, Polishchuk, Iryna, Shah, Riyaz, Mitra, Sanka, Popat, Sanjaykumar, Spicer, James, Toy, Elizabeth, Popat, Sanjaykumar, Talbot, Toby, Brown, Emma, Upadhyay, Sunil, Summers, Yvonne, Gurtler, Jayne, Meza, Luis, and Thropay, John

Published
2016
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28. Second-line nintedanib plus docetaxel for patients with lung adenocarcinoma after failure on first-line immune checkpoint inhibitor combination therapy: Initial efficacy and safety results from VARGADO Cohort C.

Author

Grohé, Christian, primary, Wehler, Thomas, additional, Dechow, Tobias, additional, Henschke, Sven, additional, Schuette, Wolfgang, additional, Dittrich, Ina, additional, Hammerschmidt, Stefan, additional, Müller-Huesmann, Harald, additional, Schumann, Christian, additional, Krüger, Stefan, additional, Atz, Judith, additional, and Kaiser, Rolf, additional

Published
2021
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29. A Randomized Phase II Trial Comparing the Efficacy and Safety of Pioglitazone, Clarithromycin and Metronomic Low-Dose Chemotherapy with Single-Agent Nivolumab Therapy in Patients with Advanced Non-small Cell Lung Cancer Treated in Second or Further Line (ModuLung)

Author

Heudobler, Daniel, Schulz, Christian, Fischer, Jürgen R., Staib, Peter, Wehler, Thomas, Südhoff, Thomas, Schichtl, Thomas, Wilke, Jochen, Hahn, Joachim, Lüke, Florian, Vogelhuber, Martin, Klobuch, Sebastian, Pukrop, Tobias, Herr, Wolfgang, Held, Swantje, Beckers, Kristine, Bouche, Gauthier, and Reichle, Albrecht

Subjects
Pharmacology, ddc:610, 610 Medizin, Pharmacology (medical), biomodulation, anakoinosis, NSCLC, checkpoint inhibition, pioglitazone, nivolumab, priming, metronomic chemotherapy, clarithromycin
Abstract

Background: Most non-small cell lung cancers occur in elderly and frequently comorbid patients. Therefore, it is necessary to evaluate the efficacy of biomodulatory active therapy regimen, concertedly interfering with tumor-associated homeostatic pathways to achieve tumor control paralleled by modest toxicity profiles. Patients and Methods: The ModuLung trial is a national, multicentre, prospective, open-label, randomized phase II trial in patients with histologically confirmed stage IIIB/IV squamous (n = 11) and non-squamous non-small cell (n = 26) lung cancer who failed first-line platinum-based chemotherapy. Patients were randomly assigned on a 1:1 ratio to the biomodulatory or control group, treated with nivolumab. Patients randomized to the biomodulatory group received an all-oral therapy consisting of treosulfan 250 mg twice daily, pioglitazone 45 mg once daily, clarithromycin 250 mg twice daily, until disease progression or unacceptable toxicity. Results: The study had to be closed pre-maturely due to approval of immune checkpoint inhibitors (ICi) in first-line treatment. Thirty-seven patients, available for analysis, were treated in second to forth-line. Progression-free survival (PFS) was significantly inferior for biomodulation (N = 20) vs. nivolumab (N = 17) with a median PFS (95% confidence interval) of 1.4 (1.2–2.0) months vs. 1.6 (1.4–6.2), respectively; with a hazard ratio (95% confidence interval) of 1.908 [0.962; 3.788]; p = 0.0483. Objective response rate was 11.8% with nivolumab vs. 5% with biomodulation, median follow-up 8.25 months. The frequency of grade 3–5 treatment related adverse events was 29% with nivolumab and 10% with biomodulation. Overall survival (OS), the secondary endpoint, was comparable in both treatment arms; biomodulation with a median OS (95% confidence interval) of 9.4 (6.0–33.0) months vs. nivolumab 6.9 (4.6–24.0), respectively; hazard ratio (95% confidence interval) of 0.733 [0.334; 1.610]; p = 0.4368. Seventy-five percent of patients in the biomodulation arm received rescue therapy with checkpoint inhibitors. Conclusions: This trial shows that the biomodulatory therapy was inferior to nivolumab on PFS. However, the fact that OS was similar between groups gives rise to the hypothesis that the well-tolerable biomodulatory therapy may prime tumor tissues for efficacious checkpoint inhibitor therapy, even in very advanced treatment lines where poor response to ICi might be expected with increasing line of therapy.

Published
2021
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30. KRAS G12C-mutated advanced non-small cell lung cancer: A real-world cohort from the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315)

Author

Sebastian, Martin, Eberhardt, Wilfried E. E., Hoffknecht, Petra, Metzenmacher, Martin, Wehler, Thomas, Kokowski, Konrad, Alt, Juergen, Schuette, Wolfgang, Buettner, Reinhard, Heukamp, Lukas C., Stenzinger, Albrecht, Jaenicke, Martina, Fleitz, Annette, Zacharias, Stefan, Dille, Stephanie, Hipper, Annette, Sandberg, Marlen, Weichert, Wilko, Groschek, Matthias, von der Heyde, Eyck, Rauh, Jacqueline, Dechow, Tobias, Thomas, Michael, Griesinger, Frank, Sebastian, Martin, Eberhardt, Wilfried E. E., Hoffknecht, Petra, Metzenmacher, Martin, Wehler, Thomas, Kokowski, Konrad, Alt, Juergen, Schuette, Wolfgang, Buettner, Reinhard, Heukamp, Lukas C., Stenzinger, Albrecht, Jaenicke, Martina, Fleitz, Annette, Zacharias, Stefan, Dille, Stephanie, Hipper, Annette, Sandberg, Marlen, Weichert, Wilko, Groschek, Matthias, von der Heyde, Eyck, Rauh, Jacqueline, Dechow, Tobias, Thomas, Michael, and Griesinger, Frank

Abstract

Objectives: After decades of unsuccessful efforts in inhibiting KRAS, promising clinical data targeting the muta-tion subtype G12C emerge. Since little is known about outcome with standard treatment of patients with G12C mutated non-small cell lung cancer (NSCLC), we analyzed a large, representative, real-world cohort from Germany. Patients and methods: A total of 1039 patients with advanced KRAS-mutant or-wildtype NSCLC without drug-gable alterations have been recruited in the prospective, observational registry CRISP from 12/2015 to 06/2019 by 98 centers in Germany. Details on treatment, best response, and outcome were analyzed for patients with KRAS wildtype, G12C, and non-G12C mutations. Results: Within the study population, 160 (15.4 %) patients presented with KRAS G12C, 251 (24.2 %) with nonG12C mutations, 628 (60.4 %) with KRAS wildtype. High PD-L1 expression (Tumor Proportion Score, TPS > 50 %) was documented for 28.0 %, 43.5 %, and 28.9 % (wildtype, G12C, non-G12C) of the tested patients; 68.8 %, 89.3 %, and 87.7 % of the patients received first-line treatment combined with an immune checkpoint-inhibitor in 2019. TPS > 50 % vs. TPS < 1 % was associated with a significantly decreased risk of mortality in a multivariate Cox model (HR 0.39, 95 % CI 0.26-0.60, p=<0.001). There were no differences in clinical outcome between KRAS wildtype, G12C or non-G12C mutations and KRAS mutational status was not prognostic in the model. Conclusion: Here we describe the so far largest prospectively recruited cohort of patients with advanced NSCLC and KRAS mutations, with special focus on the G12C mutation. These data constitute an extremely valuable historical control for upcoming clinical studies that employ KRAS inhibitors.

Published
2021

31. KRAS G12C-mutated advanced non-small cell lung cancer: A real-world cohort from the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315)

Author

Sebastian, Martin, primary, Eberhardt, Wilfried E.E., additional, Hoffknecht, Petra, additional, Metzenmacher, Martin, additional, Wehler, Thomas, additional, Kokowski, Konrad, additional, Alt, Jürgen, additional, Schütte, Wolfgang, additional, Büttner, Reinhard, additional, Heukamp, Lukas C., additional, Stenzinger, Albrecht, additional, Jänicke, Martina, additional, Fleitz, Annette, additional, Zacharias, Stefan, additional, Dille, Stephanie, additional, Hipper, Annette, additional, Sandberg, Marlen, additional, Weichert, Wilko, additional, Groschek, Matthias, additional, von der Heyde, Eyck, additional, Rauh, Jacqueline, additional, Dechow, Tobias, additional, Thomas, Michael, additional, and Griesinger, Frank, additional

Published
2021
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32. A Randomized Phase II Trial Comparing the Efficacy and Safety of Pioglitazone, Clarithromycin and Metronomic Low-Dose Chemotherapy with Single-Agent Nivolumab Therapy in Patients with Advanced Non-small Cell Lung Cancer Treated in Second or Further Line (ModuLung)

Author

Heudobler, Daniel, primary, Schulz, Christian, additional, Fischer, Jürgen R., additional, Staib, Peter, additional, Wehler, Thomas, additional, Südhoff, Thomas, additional, Schichtl, Thomas, additional, Wilke, Jochen, additional, Hahn, Joachim, additional, Lüke, Florian, additional, Vogelhuber, Martin, additional, Klobuch, Sebastian, additional, Pukrop, Tobias, additional, Herr, Wolfgang, additional, Held, Swantje, additional, Beckers, Kristine, additional, Bouche, Gauthier, additional, and Reichle, Albrecht, additional

Published
2021
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35. Abstract CT288: Phase 3, randomized, placebo-controlled study of stereotactic body radiotherapy (SBRT) with or without pembrolizumab in patients with inoperable stage I/IIA non-small-cell lung cancer (NSCLC): KEYNOTE-867

Author

Jabbour, Salma K., primary, Houghton, Baerin, additional, Robinson, Andrew G., additional, Quantin, Xavier, additional, Wehler, Thomas, additional, Kowalski, Dariusz, additional, Ahn, Myung-Ju, additional, Erman, Mustafa, additional, Giaccone, Giuseppe, additional, Borghaei, Hossein, additional, McLean, Jessica, additional, Zhang, Jin, additional, Souza, Fabricio, additional, and Decker, Roy, additional

Published
2020
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36. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non–Small-Cell Lung Cancer

Author

Reck, Martin, primary, Wehler, Thomas, additional, Orlandi, Francisco, additional, Nogami, Naoyuki, additional, Barone, Carlo, additional, Moro-Sibilot, Denis, additional, Shtivelband, Mikhail, additional, González Larriba, Jose Luis, additional, Rothenstein, Jeffrey, additional, Früh, Martin, additional, Yu, Wei, additional, Deng, Yu, additional, Coleman, Shelley, additional, Shankar, Geetha, additional, Patel, Hina, additional, Kelsch, Claudia, additional, Lee, Anthony, additional, Piault, Elisabeth, additional, and Socinski, Mark A., additional

Published
2020
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37. Randomised phase II trial of trofosfamide vs. doxorubicin in elderly patients with untreated metastatic soft-tissue sarcoma

Author

Hartmann, Joerg T., primary, Kopp, Hans-G., additional, Gruenwald, Viktor, additional, Piperno-Neumann, Sophie, additional, Kunitz, Annegret, additional, Hofheinz, Ralf, additional, Mueller, Lothar, additional, Geissler, Michael, additional, Horger, Marius, additional, Fix, Peter, additional, Chemnitz, Jens M., additional, Neise, Michael, additional, Wehler, Thomas, additional, Zander, Ingo, additional, Eckert, Robert, additional, Hann von Weyhern, Claus, additional, Bauer, Sebastian, additional, and Mayer, Frank, additional

Published
2020
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38. Additional file 8: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Subjects
body regions, nervous system, fungi, sense organs, macromolecular substances
Abstract

Figure S2. Heatmap showing broadening of the humoral immune response against antigens in several of the evaluated patients. (PDF 411 kb)

Published
2019
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39. Additional file 1: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Abstract

Supplementary Materials and Methods. (PDF 465 kb)

Published
2019
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40. Additional file 4: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Abstract

Table S3. Treatment exposure during the study. (PDF 322 kb)

Published
2019
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41. Additional file 2: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Subjects
body regions, nervous system, fungi
Abstract

Table S1. Peptide sequences of short class-I peptides. (PDF 79 kb)

Published
2019
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42. Additional file 9: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Subjects
body regions, nervous system, fungi
Abstract

Table S6. Best overall response by lesion type (safety analysis set). (PDF 256 kb)

Published
2019
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43. Additional file 3: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Abstract

Table S2. Screening failures. (PDF 250 kb)

Published
2019
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44. Additional file 6: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Jürgen Alt, Bischoff, Helge, GeißLer, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Subjects
fungi
Abstract

Figure S1. Evaluation of cellular immunity in patients receiving BI1361849 immunotherapy combined with local radiation treatment: representative examples. (PDF 3990 kb)

Published
2019
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45. Identification of a potential allosteric site of Golgi α-mannosidase II using computer-aided drug design

Author

Irsheid, Lina, Wehler, Thomas, Borek, Christoph, Kiefer, Werner, Brenk, Ruth, Ortiz-Soto, Maria Elena, Seibel, Jürgen, and Schirmeister, Tanja

Subjects
Hydrolases, Golgi Apparatus, Physical Chemistry, Biochemistry, 570 Life sciences, Isomers, Binding Analysis, Stereochemistry, Stereoisomers, Cloning, Molecular, Drosophila Melanogaster, Eukaryota, Animal Models, Recombinant Proteins, Enzymes, Insects, Molecular Docking Simulation, Chemistry, Bioassays and Physiological Analysis, Experimental Organism Systems, Physical Sciences, Medicine, Drosophila, Allosteric Site, Research Article, 570 Biowissenschaften, Arthropoda, Glycoside Hydrolases, Science, Research and Analysis Methods, Model Organisms, Isomerism, alpha-Mannosidase, Animals, Protein Structure, Quaternary, Chemical Characterization, Enzyme Assays, Binding Sites, Chemical Bonding, Organisms, Chemical Compounds, Biology and Life Sciences, Proteins, Hydrogen Bonding, Invertebrates, Drug Design, Enzyme Structure, Animal Studies, Enzymology, Electrostatic Bonding, Biochemical Analysis
Abstract

Golgi α-mannosidase II (GMII) is a glycoside hydrolase playing a crucial role in the N-glycosylation pathway. In various tumour cell lines, the distribution of N-linked sugars on the cell surface is modified and correlates with the progression of tumour metastasis. GMII therefore is a possible molecular target for anticancer agents. Here, we describe the identification of a non-competitive GMII inhibitor using computer-aided drug design methods including identification of a possible allosteric binding site, pharmacophore search and virtual screening. publishedVersion

Published
2019
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46. Additional file 5: of Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Papachristofilou, Alexandros, Hipp, Madeleine, Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiss, Christian, Miklos Pless, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Alt, Jürgen, Bischoff, Helge, Geißler, Michael, Griesinger, Frank, Karl-Josef Kallen, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Henoch Hong, Koch, Sven, Gnad-Vogt, Ulrike, and Zippelius, Alfred

Subjects
fungi
Abstract

Table S4. Treatment-emergent adverse events occurring in ≥10% of patients overall by preferred term (safety analysis set). (PDF 309 kb)

Published
2019
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47. Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Author

Ashman, Jamie, Lockley, Andy, Papachristofilou, Alexandros, Hipp, Madeleine M., Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiß, Christian, Pless, Miklos, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Alt, Jürgen, Bischoff, Helge, Geißler, Michael, Griesinger, Frank, Kallen, Karl-Josef, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Hong, Henoch Sangjoon, Koch, Sven D., Gnad-Vogt, Ulrike, Zippelius, Alfred, Ashman, Jamie, Lockley, Andy, Papachristofilou, Alexandros, Hipp, Madeleine M., Klinkhardt, Ute, Früh, Martin, Sebastian, Martin, Weiß, Christian, Pless, Miklos, Cathomas, Richard, Hilbe, Wolfgang, Pall, Georg, Wehler, Thomas, Alt, Jürgen, Bischoff, Helge, Geißler, Michael, Griesinger, Frank, Kallen, Karl-Josef, Fotin-Mleczek, Mariola, Schröder, Andreas, Scheel, Birgit, Muth, Anke, Seibel, Tobias, Stosnach, Claudia, Doener, Fatma, Hong, Henoch Sangjoon, Koch, Sven D., Gnad-Vogt, Ulrike, and Zippelius, Alfred

Abstract

Background: Preclinical studies demonstrate synergism between cancer immunotherapy and local radiation, enhancing anti-tumor effects and promoting immune responses. BI1361849 (CV9202) is an active cancer immunotherapeutic comprising protamine-formulated, sequence-optimized mRNA encoding six non-small cell lung cancer (NSCLC)-associated antigens (NY-ESO-1, MAGE-C1, MAGE-C2, survivin, 5T4, and MUC-1), intended to induce targeted immune responses. Methods: We describe a phase Ib clinical trial evaluating treatment with BI1361849 combined with local radiation in 26 stage IV NSCLC patients with partial response (PR)/stable disease (SD) after standard first-line therapy. Patients were stratified into three strata (1: non-squamous NSCLC, no epidermal growth factor receptor (EGFR) mutation, PR/SD after ≥4 cycles of platinum- and pemetrexed-based treatment [n = 16]; 2: squamous NSCLC, PR/SD after ≥4 cycles of platinum-based and non-platinum compound treatment [n = 8]; 3: non-squamous NSCLC, EGFR mutation, PR/SD after ≥3 and ≤ 6 months EGFR-tyrosine kinase inhibitor (TKI) treatment [n = 2]). Patients received intradermal BI1361849, local radiation (4 × 5 Gy), then BI1361849 until disease progression. Strata 1 and 3 also had maintenance pemetrexed or continued EGFR-TKI therapy, respectively. The primary endpoint was evaluation of safety; secondary objectives included assessment of clinical efficacy (every 6 weeks during treatment) and of immune response (on Days 1 [baseline], 19 and 61). Results: Study treatment was well tolerated; injection site reactions and flu-like symptoms were the most common BI1361849-related adverse events. Three patients had grade 3 BI1361849-related adverse events (fatigue, pyrexia); there was one grade 3 radiation-related event (dysphagia). In comparison to baseline, immunomonitoring revealed increased BI1361849 antigen-specific immune responses in the majority of patients (84%), whereby antigen-specific antibody levels were increased in 80% and fun

Published
2019

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