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

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage III Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

• NCT number: NCT01948141
• Study type: Interventional
• Source: Roswell Park Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2014