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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)

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ClinicalTrials.gov Identifier: NCT00656136
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : November 27, 2013
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 4, 2008
First Posted Date  ICMJE April 10, 2008
Results First Submitted Date  ICMJE August 8, 2013
Results First Posted Date  ICMJE November 27, 2013
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE April 2008
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
Overall survival time (OS) [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
  • PFS, ORR, Duration of clinical benefit [ Time Frame: 7 months ]
  • Time to ORR [ Time Frame: 7 months ]
  • Duration of ORR [ Time Frame: 7 months ]
  • Safety and PK of BIBW 2992 [ Time Frame: 7 months ]
  • HRQOL [ Time Frame: 7 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: placebo
    Patients receive placebo 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients receive placebo once daily
    Intervention: Drug: placebo
  • Experimental: BIBW 2992
    Patients receive BIBW 2992 tablets once daily
    Intervention: Drug: BIBW 2992
Publications * 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. Erratum in: Lancet Oncol. 2012 May;13(5):e186.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2010)
585
Original Enrollment  ICMJE
 (submitted: April 9, 2008)
400
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   China,   France,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00656136
Other Study ID Numbers  ICMJE 1200.23
2007-005983-28 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP