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

June 24, 2016 updated by: Boehringer Ingelheim

Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

585

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium
        • 1200.23.32004 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1200.23.32003 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 1200.23.32001 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1200.23.32005 Boehringer Ingelheim Investigational Site
      • Namur, Belgium
        • 1200.23.32006 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • 1200.23.1002 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1200.23.1005 Boehringer Ingelheim Investigational Site
    • Ontario
      • Toronto, Ontario, Canada
        • 1200.23.1009 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1200.23.1001 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1200.23.1004 Boehringer Ingelheim Investigational Site
  • China
      • Beijing, China
        • 1200.23.86001 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1200.23.86002 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1200.23.86003 Boehringer Ingelheim Investigational Site
      • Chengdu, China
        • 1200.23.86009 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1200.23.86007 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 1200.23.86008 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1200.23.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1200.23.86005 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1200.23.86006 Boehringer Ingelheim Investigational Site
  • France
      • Besançon Cedex, France
        • 1200.23.3303A Boehringer Ingelheim Investigational Site
      • Besançon Cedex, France
        • 1200.23.3303C Boehringer Ingelheim Investigational Site
      • Caen Cedex 5, France
        • 1200.23.3305A Boehringer Ingelheim Investigational Site
      • La Tronche, France
        • 1200.23.3304A Boehringer Ingelheim Investigational Site
      • La Tronche, France
        • 1200.23.3304B Boehringer Ingelheim Investigational Site
      • Lyon Cedex 4, France
        • 1200.23.3307A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1200.23.3302A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1200.23.3302B Boehringer Ingelheim Investigational Site
      • Paris cedex 20, France
        • 1200.23.3301A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, France
        • 1200.23.3306A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, France
        • 1200.23.3306C Boehringer Ingelheim Investigational Site
  • Germany
      • Bad Berka, Germany
        • 1200.23.49010 Zentralklinik Bad Berka GmbH
      • Essen, Germany
        • 1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)
      • Gauting, Germany
        • 1200.23.49003 Asklepios Fachkliniken München-Gauting
      • Großhansdorf, Germany
        • 1200.23.49005 Krankenhaus Großhansdorf
      • Hamburg, Germany
        • 1200.23.49008 Universitätsklinik Hamburg-Eppendorf
      • Mainz, Germany
        • 1200.23.49004 Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany
        • 1200.23.49001 Universitätsklinikum Mannheim
      • Wiesbaden, Germany
        • 1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH
  • Hong Kong
      • Hong Kong, Hong Kong
        • 1200.23.85202 Boehringer Ingelheim Investigational Site
  • Italy
      • Genova, Italy
        • 1200.23.39003 Boehringer Ingelheim Investigational Site
      • Orbassano (TO), Italy
        • 1200.23.39007 Boehringer Ingelheim Investigational Site
      • Perugia, Italy
        • 1200.23.39002 Boehringer Ingelheim Investigational Site
      • Prato, Italy
        • 1200.23.39004 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1200.23.39008 Boehringer Ingelheim Investigational Site
      • Rozzano (MI), Italy
        • 1200.23.39001 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • 1200.23.82005 Boehringer Ingelheim Investigational Site
      • Hwasun, Korea, Republic of
        • 1200.23.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1200.23.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1200.23.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1200.23.82003 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1200.23.82004 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amsterdam, Netherlands
        • 1200.23.31002 Boehringer Ingelheim Investigational Site
      • Groningen, Netherlands
        • 1200.23.31001 Boehringer Ingelheim Investigational Site
      • Helmond, Netherlands
        • 1200.23.31003 Boehringer Ingelheim Investigational Site
  • Singapore
      • Singapore, Singapore
        • 1200.23.65001 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1200.23.3405 Boehringer Ingelheim Investigational Site
      • Cruces, Spain
        • 1200.23.3404 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1200.23.3401 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1200.23.3403 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1200.23.3406 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1200.23.3402 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Taichung, Taiwan
        • 1200.23.88604 Taichung Veterans General Hospital
      • Taichung, Taiwan
        • 1200.23.88605 China Medical University Hospital
      • Tainan, Taiwan
        • 1200.23.88606 National Cheng Kung University Hospital
      • Taipei, Taiwan
        • 1200.23.88601 National Taiwan University Hospital
      • Taipei, Taiwan
        • 1200.23.88602 Veterans General Hospital
      • Taipei, Taiwan
        • 1200.23.88607 Tri-Service General Hospital
      • Taoyuan, Taiwan
        • 1200.23.88603 Chang Gung Memorial Hosp-Linkou
  • Thailand
      • Chiangmai, Thailand
        • 1200.23.66001 Boehringer Ingelheim Investigational Site
      • Pathumwan, Bangkok, Thailand
        • 1200.23.66003 Boehringer Ingelheim Investigational Site
      • Songkla, Thailand
        • 1200.23.66002 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Dundee, United Kingdom
        • 1200.23.4404 Boehringer Ingelheim Investigational Site
      • Edinburgh, United Kingdom
        • 1200.23.4403 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 1200.23.4401 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1200.23.4405 Boehringer Ingelheim Investigational Site
      • Sutton, United Kingdom
        • 1200.23.4406 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Kingman, Arizona, United States
        • 1200.23.038 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States
        • 1200.23.046 Boehringer Ingelheim Investigational Site
    • California
      • Anaheim, California, United States
        • 1200.23.027 Boehringer Ingelheim Investigational Site
      • Berkeley, California, United States
        • 1200.23.028 Boehringer Ingelheim Investigational Site
      • Modesto, California, United States
        • 1200.23.029 Boehringer Ingelheim Investigational Site
      • Montebello, California, United States
        • 1200.23.045 Boehringer Ingelheim Investigational Site
      • Orange, California, United States
        • 1200.23.009 Boehringer Ingelheim Investigational Site
      • Palm Springs, California, United States
        • 1200.23.026 Boehringer Ingelheim Investigational Site
    • Florida
      • North Miami Beach, Florida, United States
        • 1200.23.024 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1200.23.020 Boehringer Ingelheim Investigational Site
      • Valhalla, New York, United States
        • 1200.23.013 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt lake City, Utah, United States
        • 1200.23.056 Boehringer Ingelheim Investigational Site
    • Washington
      • Renton, Washington, United States
        • 1200.23.039 Boehringer Ingelheim Investigational Site
      • Seattle, Washington, United States
        • 1200.23.050 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients receive placebo once daily
Drug: placebo
Patients receive placebo once daily
Experimental: BIBW 2992
Patients receive BIBW 2992 tablets once daily
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization until death or the last patient out date, an average of 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
Objective Response Rate (OR)
Time Frame: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.
From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.23
  • 2007-005983-28 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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