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 (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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Given PO
Roswell Park Cancer Institute
Buffalo, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time frame: At 6 months
Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Time frame: Time from study entry to the first of either disease progression or death, assessed at 6 months
Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Time frame: Time from study entry to the first of either disease progression or death, assessed at 6 months
6-month PFS Rate for Each of the FGFRI Amplified Groups (Low, Intermediate, High) in Comparison to Historical Controls
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Time frame: Time from study entry to the first of either disease progression or death, assessed at 6 months
Overall Survival (OS)
Overall survival (OS) was defined as the time from study entry to death from any cause.
Time frame: From study entry to death from any cause, assessed up to 3 years
Tumor Response Rate
Tumor Response rate was defined as the proportion of patients who had Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to 3 years
Incidence of Adverse Events (AEs)
Percentage of participants with adverse events. Incidence of Adverse Events (AEs) was Accessed by the National Cancer Institute (NCI) CTCAE Version 4.0.
Time frame: Up to 30 days post-treatment
Progression Free Survival
Progression-free survival (PFS) was defined as the time from study entry to the first of either disease progression or death.
Time frame: Time from study entry to the first of either disease progression or death, assessed up to 3 years
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