Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
FGFR1 Amplification as A Predictor of Efficacy in A Biomarker-Driven Phase II Study of BIBF 1120 in Advanced Squamous Cell Lung Cancer Patients Who Have Failed Up to Two Prior Chemotherapeutic Regimens
This phase II trial studies how well nintedanib works in treating patients with advanced non-small cell lung cancer who have failed up to two previous chemotherapy regimens. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the 6-month progression-free survival (PFS) rate of fibroblast growth factor
receptor 1 (FGFRI) amplified squamous cell lung cancer patients treated with BIBF 1120
(nintedanib).
SECONDARY OBJECTIVES:
I. Compare the 6-month PFS rate for the entire FGFRI amplified group versus the FGFRI
wild-type patients.
II. Compare the 6-month PFS rate for each FGFRI amplified group (low, intermediate, and
high) versus historical controls and FGFRI wild-type patients.
III. To assess the following endpoints overall and by FGFRI group: PFS, overall survival
(OS), confirmed tumor response rate, and adverse events.
TERTIARY OBJECTIVES:
I. The relation of FGFRI gene copy number with PFS, OS, confirmed response rate, and adverse
events.
II. The relationship fibroblast growth factor receptor (FGFR) polymorphisms with toxicity
and efficacy.
OUTLINE:
Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 8 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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