Phase 2
N=6
Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens
Recurrent Non-small Cell Lung Cancer · Squamous Cell Lung Cancer · Stage III Non-small Cell Lung Cancer · Stage IV Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01948141 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Jun 2017
Primary outcome: Primary: 6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- nintedanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group |
— | — |
| SECONDARY Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients. |
0; 0; 0 | — |
| SECONDARY Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients. |
0; 0; 0; 0 | — |
| SECONDARY 6-month PFS Rate for Each of the FGFRI Amplified Groups (Low, Intermediate, High) in Comparison to Historical Controls |
— | — |
| SECONDARY Overall Survival (OS) |
10.2; 5.8; 10.6 | 0.59 |
| SECONDARY Tumor Response Rate |
0; 0; 0 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
100; 100; 100 | — |
| SECONDARY Progression Free Survival |
2.7; 1.8; 3.4 | 0.36 |
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.
Eligibility Criteria
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 = = 1500/uL
- Hemoglobin (HgB) >= 9 g/dL
- Platelets >= 100,000/uL
- Total bilirubin = = 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 = = 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 receptor (EGFR) mutation and/or anaplastic lymphoma receptor tyrosine kinase (ALK) translocation
- Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; patients with asymptomatic CNS metastases treated with whole brain radiation (WBRT) or gamma knife radiosurgery (GKR) may be enrolled >= 1 week after completion of WBRT/GKR provided toxicities are = = 2 weeks after completion of WBRT/GKR provided toxicities are = 10% of baseline body mass) within past 6 months prior to inclusion into the study
- Coagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
- Proteinuria by Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
- Known inherited predisposition to bleeding or thrombosis
- Therapeutic anticoagulation (except for low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
- Baseline hemoptysis, per clinician/investigator evaluation
- Active alcohol or drug abuse
- History of arterial or venous thrombotic/embolic events =< 12 months prior to registration
- Prior history with BIBF 1120 or any other vascular endothelial growth factor (VEGF)/VEGF receptor (R) inhibitor
- New York Heart Association (NYHA) class III or IV; NOTE: patients classified as NYHA class II controlled with treatment may participate, with increased monitoring
Data sourced from ClinicalTrials.gov (NCT01948141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.