Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Tw… (NCT01948141) | Clinical Trial Compass
CompletedPhase 2
Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens
United States6 participantsStarted 2014-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with advanced histologically proven squamous cell carcinoma of the lung
* Patients who have failed at least 1 systemic chemotherapy regimen for metastatic disease, but not more than 2 regimens
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* The pathologic tissue is available to determine FGFR1 amplification status
* Presence of either evaluable disease or measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Absolute neutrophil count (ANC) \>= 1500/uL
* Hemoglobin (HgB) \>= 9 g/dL
* Platelets \>= 100,000/uL
* Total bilirubin =\< upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 1.5 x ULN (ALT and AST =\< 2.5 x ULN is acceptable if there is liver metastasis)
* Calculated or measured creatinine clearance \>= 45 mL/min
* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment and have a negative serum or urine pregnancy test done =\< 7 days prior to registration (for women of childbearing potential only)
* Life expectancy \>= 12 weeks
* Willingness to provide the blood specimens as required by the protocol; please note that the willingness to participate pertains only to the patient and does not factor in the institution's ability to participate in any part of the translational component
Exclusion Criteria:
* Patients with any known endothelial growth factor re…
What they're measuring
1
6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group