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

NCT ID: NCT00656136

Last Updated: 2016-07-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

585 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Patients receive placebo once daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Patients receive placebo once daily

BIBW 2992

Patients receive BIBW 2992 tablets once daily

Group Type EXPERIMENTAL

BIBW 2992

Intervention Type 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.

Interventions

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placebo

Patients receive placebo once daily

Intervention Type DRUG

BIBW 2992

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
4. 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
5. Male and female patients age \>18 years
6. Life expectancy of at least three (3) months
7. Written informed consent that is consistent with ICH-GCP guidelines

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1200.23.038 Boehringer Ingelheim Investigational Site

Kingman, Arizona, United States

Site Status

1200.23.046 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

Site Status

1200.23.027 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Site Status

1200.23.028 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

1200.23.029 Boehringer Ingelheim Investigational Site

Modesto, California, United States

Site Status

1200.23.045 Boehringer Ingelheim Investigational Site

Montebello, California, United States

Site Status

1200.23.009 Boehringer Ingelheim Investigational Site

Orange, California, United States

Site Status

1200.23.026 Boehringer Ingelheim Investigational Site

Palm Springs, California, United States

Site Status

1200.23.024 Boehringer Ingelheim Investigational Site

North Miami Beach, Florida, United States

Site Status

1200.23.020 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1200.23.013 Boehringer Ingelheim Investigational Site

Valhalla, New York, United States

Site Status

1200.23.056 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

1200.23.039 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Site Status

1200.23.050 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Site Status

1200.23.32004 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

1200.23.32003 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1200.23.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1200.23.32005 Boehringer Ingelheim Investigational Site

Liège, , Belgium

Site Status

1200.23.32006 Boehringer Ingelheim Investigational Site

Namur, , Belgium

Site Status

1200.23.1002 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1200.23.1005 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1200.23.1009 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1200.23.1001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1200.23.1004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1200.23.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1200.23.86002 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1200.23.86003 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1200.23.86009 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1200.23.86007 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1200.23.86008 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1200.23.86004 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1200.23.86005 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1200.23.86006 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1200.23.3303A Boehringer Ingelheim Investigational Site

Besançon, , France

Site Status

1200.23.3303C Boehringer Ingelheim Investigational Site

Besançon, , France

Site Status

1200.23.3305A Boehringer Ingelheim Investigational Site

Caen, , France

Site Status

1200.23.3304A Boehringer Ingelheim Investigational Site

La Tronche, , France

Site Status

1200.23.3304B Boehringer Ingelheim Investigational Site

La Tronche, , France

Site Status

1200.23.3307A Boehringer Ingelheim Investigational Site

Lyon, , France

Site Status

1200.23.3301A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1200.23.3302A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1200.23.3302B Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1200.23.3306A Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1200.23.3306C Boehringer Ingelheim Investigational Site

Toulouse, , France

Site Status

1200.23.49010 Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status

1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)

Essen, , Germany

Site Status

1200.23.49003 Asklepios Fachkliniken München-Gauting

Gauting, , Germany

Site Status

1200.23.49005 Krankenhaus Großhansdorf

Großhansdorf, , Germany

Site Status

1200.23.49008 Universitätsklinik Hamburg-Eppendorf

Hamburg, , Germany

Site Status

1200.23.49004 Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

1200.23.49001 Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status

1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH

Wiesbaden, , Germany

Site Status

1200.23.85202 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

Site Status

1200.23.39003 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1200.23.39007 Boehringer Ingelheim Investigational Site

Orbassano (TO), , Italy

Site Status

1200.23.39002 Boehringer Ingelheim Investigational Site

Perugia, , Italy

Site Status

1200.23.39004 Boehringer Ingelheim Investigational Site

Prato, , Italy

Site Status

1200.23.39008 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1200.23.39001 Boehringer Ingelheim Investigational Site

Rozzano (MI), , Italy

Site Status

1200.23.31002 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1200.23.31001 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Site Status

1200.23.31003 Boehringer Ingelheim Investigational Site

Helmond, , Netherlands

Site Status

1200.23.65001 Boehringer Ingelheim Investigational Site

Singapore, , Singapore

Site Status

1200.23.82005 Boehringer Ingelheim Investigational Site

Gyeonggi-do, , South Korea

Site Status

1200.23.82006 Boehringer Ingelheim Investigational Site

Hwasun, , South Korea

Site Status

1200.23.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.23.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.23.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.23.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.23.3405 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1200.23.3404 Boehringer Ingelheim Investigational Site

Cruces, , Spain

Site Status

1200.23.3401 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1200.23.3403 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1200.23.3406 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1200.23.3402 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1200.23.88604 Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

1200.23.88605 China Medical University Hospital

Taichung, , Taiwan

Site Status

1200.23.88606 National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

1200.23.88601 National Taiwan University Hospital

Taipei, , Taiwan

Site Status

1200.23.88602 Veterans General Hospital

Taipei, , Taiwan

Site Status

1200.23.88607 Tri-Service General Hospital

Taipei, , Taiwan

Site Status

1200.23.88603 Chang Gung Memorial Hosp-Linkou

Taoyuan District, , Taiwan

Site Status

1200.23.66001 Boehringer Ingelheim Investigational Site

Chiang Mai, , Thailand

Site Status

1200.23.66003 Boehringer Ingelheim Investigational Site

Pathumwan, Bangkok, , Thailand

Site Status

1200.23.66002 Boehringer Ingelheim Investigational Site

Songkhla, , Thailand

Site Status

1200.23.4404 Boehringer Ingelheim Investigational Site

Dundee, , United Kingdom

Site Status

1200.23.4403 Boehringer Ingelheim Investigational Site

Edinburgh, , United Kingdom

Site Status

1200.23.4401 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

Site Status

1200.23.4405 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1200.23.4406 Boehringer Ingelheim Investigational Site

Sutton, , United Kingdom

Site Status

Countries

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United States Belgium Canada China France Germany Hong Kong Italy Netherlands Singapore South Korea Spain Taiwan Thailand United Kingdom

References

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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.

Reference Type DERIVED
PMID: 22452896 (View on PubMed)

Other Identifiers

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2007-005983-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.23

Identifier Type: -

Identifier Source: org_study_id

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