NCT01948141

Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free survival (PFS) rate of fibroblast growth factor receptor 1 (FGFR1) amplified squamous cell lung cancer patients treated with BIBF 1120 (nintedanib). SECONDARY OBJECTIVES: I. Compare the 6-month PFS rate for the entire FGFR1 amplified group versus the FGFR1 non-amplified patients. II. Compare the 6-month PFS rate for each FGFR1 amplified group (low, intermediate, and high) versus historical controls and FGFR1 non-amplified patients. III. To assess the following endpoints overall and by FGFR1 group: PFS, overall survival (OS), confirmed tumor response rate, and adverse events. TERTIARY OBJECTIVES: I. The relation of FGFR1 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.

Conditions

• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage III Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	nintedanib	Given PO

Timeline

• Start date: 2014-01-30
• Primary completion: 2016-08-16
• Completion: 2016-08-16
• First posted: 2013-09-23
• Last updated: 2017-06-08
• Results posted: 2017-06-08

Locations

2 sites across 1 country: United States