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

NCT01948141 | Completed Phase 2 Results DMC

• 3 other identifiers: I 225512NCI-2013-01618P30CA016056
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage III Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  At 6 months

Secondary Outcomes (7)

• Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.

  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.

  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

  Time from study entry to the first of either disease progression or death, assessed at 6 months

• Overall Survival (OS)

  From study entry to death from any cause, assessed up to 3 years

• Tumor Response Rate

  Up to 3 years

Study Arms (1)

Treatment (nintedanib)

EXPERIMENTAL

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: nintedanib

Interventions

nintedanib DRUG

Given PO

Also known as: BIBF 1120, multitargeted tyrosine kinase inhibitor BIBF 1120, Tyrosine Kinase Inhibitor BIBF 1120, Vargatef

Treatment (nintedanib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Boehringer Ingelheim: collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Hongbin Chen

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: January 30, 2014
• Primary Completion: August 16, 2016
• Study Completion: August 16, 2016
• Last Updated: June 8, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-05

Locations

US (2)