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Uncommon EGFR mutations conducted with osimertinib in patients with NSCLC: a study protocol of phase 2 study (UNICORN/TCOG1901).
- Source :
-
Future oncology (London, England) [Future Oncol] 2022 Feb; Vol. 18 (5), pp. 523-531. Date of Electronic Publication: 2022 Jan 17. - Publication Year :
- 2022
-
Abstract
- Patients with uncommon EGFR- mutated non-small-cell lung cancer (NSCLC) demonstrated lower clinical efficacy of first-generation EGFR-tyrosine kinase inhibitors compared with patients harboring common EGFR- mutated NSCLC. The US FDA has approved afatinib for uncommon EGFR mutation positive NSCLC based on the pooled analysis in the first- or second-line setting. Osimertinib has limited evidence in the small sample sizes of phase 2 studies in any-line settings. The aim of the present single-arm, multicenter, phase 2 study is to evaluate the efficacy of osimertinib for previously untreated NSCLC. The primary end point is to assess the overall response to osimertinib. The secondary end points include disease control rate, progression-free survival, duration of time-to-treatment failure, overall survival and safety. Clinical trial registration: jRCTs071200002.
- Subjects :
- Carcinoma, Non-Small-Cell Lung genetics
Clinical Trials, Phase II as Topic
ErbB Receptors genetics
Humans
Lung Neoplasms genetics
Multicenter Studies as Topic
Mutation
Research Design
Survival Analysis
Acrylamides therapeutic use
Aniline Compounds therapeutic use
Antineoplastic Agents therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Lung Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1744-8301
- Volume :
- 18
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Future oncology (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 35034503
- Full Text :
- https://doi.org/10.2217/fon-2021-0892