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Nintedanib (BIBF 1120) plus docetaxel in NSCLC patients progressing after first-line chemotherapy: LUME Lung 1, a randomized, double-blind phase III trial
- Source :
- Journal of Clinical Oncology. 31:LBA8011-LBA8011
- Publication Year :
- 2013
- Publisher :
- American Society of Clinical Oncology (ASCO), 2013.
-
Abstract
- LBA8011 Background: Nintedanib (N) inhibits VEGFRs, PDGFRs, and FGFRs. LUME Lung 1 is a placebo (P) controlled phase III trial of N + docetaxel (D) in patients (pts) with locally advanced/metastatic NSCLC progressing after first-line therapy. Methods: Stage IIIB/IV or recurrent NSCLC pts (stratified by histology, ECOG PS, prior bevacizumab, and brain metastases) were randomized to N 200 mg bid + D 75 mg/m2 q21d (n=655) or P + D (n=659). 1° endpoint was centrally reviewed PFS after 713 events (2 sided stratified log-rank, α=5%, β=10%). Key 2° endpoint of OS was analyzed hierarchically after 1,121 events (2 sided, adjusted α=4.98%, β=20%), first in adenocarcinoma (adeno) pts line therapy (T
- Subjects :
- Oncology
Cancer Research
medicine.medical_specialty
Lung
Bevacizumab
Lume
business.industry
Proportional hazards model
medicine.disease
Placebo
Surgery
chemistry.chemical_compound
medicine.anatomical_structure
chemistry
Docetaxel
Internal medicine
medicine
Adenocarcinoma
Nintedanib
business
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 31
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi...........ec6bc9a2ecf10926a22c5642c43722f5