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

Completed · Phase 2

Conditions studied: Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage III Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01948141

Run by

Roswell Park Cancer Institute

People needed

6

Starts

2014-01-30

Expected to finish

2016-08-16

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 =< Common Toxicity Criteria (CTC) grade I at the time of registration and/or controlled with dexamethasone 2 mg once daily for at least 5 days at the time of study treatment; patients with symptomatic CNS metastases treated with WBRT/GKR may be enrolled >= 2 weeks after completion of WBRT/GKR provided toxicities are =< CTC grade 1 at the time of registration and neurologic symptoms controlled with dexamethasone =< 2 mg once daily for at least 1 week at the time of study treatment
• Patients receiving palliative radiation to skeletal metastases may be registered as early as 1 week after completion of radiation therapy provided toxicities are =< CTC grade I at the time of registration
• Any of the following prior therapies for malignancy:
• Systemic chemotherapy =< 4 weeks prior to registration
• Radiation therapy =< 4 weeks prior to registration (exceptions noted in the prior bullet); the site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease
• Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =< 4 weeks prior to registration; minor surgery =< 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard
• Other investigational agent =< 30 days prior to study treatment
• The following patients will be excluded from this study:
• Pregnant women
• Breastfeeding women
• Men or women who are sexually active and unwilling to use a medically acceptable method of contraception (e.g., such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy; a highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least 2 years
• Second primary malignancy with the following exceptions which are allowed:
• Carcinoma in situ of the cervix
• Non-melanoma skin cancer
• History of low-grade (Gleason score =< 6) localized prostate cancer even if diagnosed < 5 years prior to registration
• Treated stage I breast cancer even if diagnosed =< 5 years prior to registration
• Other prior malignancy (including melanoma) allowed if it was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of BIBF 1120 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or extensive small bowel resection)
• Leptomeningeal disease
• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded because of possible pharmacokinetic interactions with oral investigational agents
• Unwilling to, or unable to, comply with the protocol
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring systemic antimicrobial therapy (including history of active or chronic hepatitis C and/or hepatitis B infection), significant pulmonary symptoms at baseline due to disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Centrally located tumors with radiographic evidence (computed tomography [CT] or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
• Significant weight loss (> 10% of baseline body mass) within past 6 months prior to inclusion into the study

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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