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

NCT00656136 | Completed Phase 3 Results

• 2 other identifiers: 1200.232007-005983-28
• Study Type: interventional
• Target: 585
• Locations: 15 countries
• Sites: 90

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock. For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010. For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013.

  From randomization until death or the last patient out date, an average of 12 months

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months

• Objective Response Rate (OR)

  From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients receive placebo once daily

Drug: placebo

BIBW 2992

EXPERIMENTAL

Patients receive BIBW 2992 tablets once daily

Drug: BIBW 2992

Interventions

placebo DRUG

Patients receive placebo once daily

Placebo

BIBW 2992 DRUG

Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.

BIBW 2992

Eligibility Criteria

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

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (90)

1200.23.038 Boehringer Ingelheim Investigational Site

Kingman, Arizona, United States

Location

1200.23.046 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

Location

1200.23.027 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Location

1200.23.028 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

1200.23.029 Boehringer Ingelheim Investigational Site

Modesto, California, United States

Location

1200.23.045 Boehringer Ingelheim Investigational Site

Montebello, California, United States

Location

1200.23.009 Boehringer Ingelheim Investigational Site

Orange, California, United States

Location

1200.23.026 Boehringer Ingelheim Investigational Site

Palm Springs, California, United States

Location

1200.23.024 Boehringer Ingelheim Investigational Site

North Miami Beach, Florida, United States

Location

1200.23.020 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1200.23.013 Boehringer Ingelheim Investigational Site

Valhalla, New York, United States

Location

1200.23.056 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1200.23.039 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

1200.23.050 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

1200.23.32004 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1200.23.32003 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1200.23.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1200.23.32005 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1200.23.32006 Boehringer Ingelheim Investigational Site

Namur, Belgium

Location

1200.23.1002 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1200.23.1005 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1200.23.1009 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1200.23.1001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1200.23.1004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1200.23.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1200.23.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1200.23.86003 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1200.23.86009 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

1200.23.86007 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1200.23.86008 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1200.23.86004 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1200.23.86005 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1200.23.86006 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1200.23.3303A Boehringer Ingelheim Investigational Site

Besançon, France

Location

1200.23.3303C Boehringer Ingelheim Investigational Site

Besançon, France

Location

1200.23.3305A Boehringer Ingelheim Investigational Site

Caen, France

Location

1200.23.3304A Boehringer Ingelheim Investigational Site

La Tronche, France

Location

1200.23.3304B Boehringer Ingelheim Investigational Site

La Tronche, France

Location

1200.23.3307A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1200.23.3301A Boehringer Ingelheim Investigational Site

Paris, France

Location

1200.23.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

1200.23.3302B Boehringer Ingelheim Investigational Site

Paris, France

Location

1200.23.3306A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1200.23.3306C Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1200.23.49010 Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Location

1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)

Essen, Germany

Location

1200.23.49003 Asklepios Fachkliniken München-Gauting

Gauting, Germany

Location

1200.23.49005 Krankenhaus Großhansdorf

Großhansdorf, Germany

Location

1200.23.49008 Universitätsklinik Hamburg-Eppendorf

Hamburg, Germany

Location

1200.23.49004 Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

1200.23.49001 Universitätsklinikum Mannheim

Mannheim, Germany

Location

1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH

Wiesbaden, Germany

Location

1200.23.85202 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1200.23.39003 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1200.23.39007 Boehringer Ingelheim Investigational Site

Orbassano (TO), Italy

Location

1200.23.39002 Boehringer Ingelheim Investigational Site

Perugia, Italy

Location

1200.23.39004 Boehringer Ingelheim Investigational Site

Prato, Italy

Location

1200.23.39008 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1200.23.39001 Boehringer Ingelheim Investigational Site

Rozzano (MI), Italy

Location

1200.23.31002 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1200.23.31001 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1200.23.31003 Boehringer Ingelheim Investigational Site

Helmond, Netherlands

Location

1200.23.65001 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

1200.23.82005 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

Location

1200.23.82006 Boehringer Ingelheim Investigational Site

Hwasun, South Korea

Location

1200.23.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.23.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.23.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.23.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.23.3405 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1200.23.3404 Boehringer Ingelheim Investigational Site

Cruces, Spain

Location

1200.23.3401 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1200.23.3403 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1200.23.3406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1200.23.3402 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1200.23.88604 Taichung Veterans General Hospital

Taichung, Taiwan

Location

1200.23.88605 China Medical University Hospital

Taichung, Taiwan

Location

1200.23.88606 National Cheng Kung University Hospital

Tainan, Taiwan

Location

1200.23.88601 National Taiwan University Hospital

Taipei, Taiwan

Location

1200.23.88602 Veterans General Hospital

Taipei, Taiwan

Location

1200.23.88607 Tri-Service General Hospital

Taipei, Taiwan

Location

1200.23.88603 Chang Gung Memorial Hosp-Linkou

Taoyuan District, Taiwan

Location

1200.23.66001 Boehringer Ingelheim Investigational Site

Chiang Mai, Thailand

Location

1200.23.66003 Boehringer Ingelheim Investigational Site

Pathumwan, Bangkok, Thailand

Location

1200.23.66002 Boehringer Ingelheim Investigational Site

Songkhla, Thailand

Location

1200.23.4404 Boehringer Ingelheim Investigational Site

Dundee, United Kingdom

Location

1200.23.4403 Boehringer Ingelheim Investigational Site

Edinburgh, United Kingdom

Location

1200.23.4401 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1200.23.4405 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1200.23.4406 Boehringer Ingelheim Investigational Site

Sutton, United Kingdom

Location

Related Publications (1)

• Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26.

  PMID: 22452896 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 26, 2016
• Results First Posted: November 27, 2013

Record last verified: 2016-06

Locations

DE (8); FR (11); HK (1); CA (5); IT (6); TW (7); BE (5); TH (3); KR (6); ES (6); US (14); CN (9); GB (5); SG (1); NL (3)