BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed. The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up.

Key facts

Study ID

NCT00656136

Run by

Boehringer Ingelheim

People needed

585

Starts

2008-04-01

Expected to finish

2013-10-01

Last updated by the study team

2016-07-26

Who can join

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

You may qualify if…

• Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
• Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
• Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
• Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as >20 mm using conventional techniques or >10 mm with spiral CT scan
• Male and female patients age >18 years
• Life expectancy of at least three (3) months
• Written informed consent that is consistent with ICH-GCP guidelines

You may not qualify if…

• Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
• Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
• Active brain metastases
• Significant or recent acute gastrointestinal disorders with diarrhea
• Patients who have any other life-threatening illness or organ system dysfunction,
• Other malignancies diagnosed within the past five (5) years
• Radiotherapy within the past 2 weeks prior to treatment
• History of clinically significant or uncontrolled cardiac disease
• Adequate ANC and platelet count
• Adequate liver and kidney function
• Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C

Where it is running

• 1200.23.046 Boehringer Ingelheim Investigational Site — Fayetteville, Arkansas, United States
• 1200.23.027 Boehringer Ingelheim Investigational Site — Anaheim, California, United States
• 1200.23.028 Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• 1200.23.029 Boehringer Ingelheim Investigational Site — Modesto, California, United States
• 1200.23.045 Boehringer Ingelheim Investigational Site — Montebello, California, United States
• 1200.23.009 Boehringer Ingelheim Investigational Site — Orange, California, United States
• 1200.23.026 Boehringer Ingelheim Investigational Site — Palm Springs, California, United States
• 1200.23.024 Boehringer Ingelheim Investigational Site — North Miami Beach, Florida, United States
• 1200.23.020 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1200.23.013 Boehringer Ingelheim Investigational Site — Valhalla, New York, United States
• 1200.23.056 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 1200.23.039 Boehringer Ingelheim Investigational Site — Renton, Washington, United States
• 1200.23.050 Boehringer Ingelheim Investigational Site — Seattle, Washington, United States
• 1200.23.32004 Boehringer Ingelheim Investigational Site — Edegem, Belgium
• 1200.23.32003 Boehringer Ingelheim Investigational Site — Ghent, Belgium
• 1200.23.32001 Boehringer Ingelheim Investigational Site — Leuven, Belgium
• 1200.23.32005 Boehringer Ingelheim Investigational Site — Liège, Belgium
• 1200.23.32006 Boehringer Ingelheim Investigational Site — Namur, Belgium
• 1200.23.1002 Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• 1200.23.1005 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
• 1200.23.1009 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
• 1200.23.1001 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
• 1200.23.1004 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
• 1200.23.86001 Boehringer Ingelheim Investigational Site — Beijing, China
• 1200.23.038 Boehringer Ingelheim Investigational Site — Kingman, Arizona, United States

Full record on ClinicalTrials.gov

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