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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: placebo Drug: BIBW 2992 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656136


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00656136    
Other Study ID Numbers: 1200.23
2007-005983-28 ( EudraCT Number: EudraCT )
First Posted: April 10, 2008    Key Record Dates
Results First Posted: November 27, 2013
Last Update Posted: July 26, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Afatinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents