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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00656136
First received: April 4, 2008
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: placebo
Drug: BIBW 2992
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until death or the last patient out date on 04 October 2013, an average of 12 months ] [ Designated as safety issue: No ]
    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. 13 patients, lost to follow-up, were censored at the last contact date when they were known to be still alive.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.


Enrollment: 585
Study Start Date: April 2008
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656136

  Show 90 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00656136     History of Changes
Other Study ID Numbers: 1200.23, 2007-005983-28
Study First Received: April 4, 2008
Results First Received: August 8, 2013
Last Updated: September 25, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
China: Food and Drug Administration
France: AFFSAPS
Germany: Ministry of Health
Great Britain: MHRA
Hong Kong: Department of Health
Italy: Comitato Etico Azienda USL 4 - PRATO
Korea, Republic of: Korea Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Singapore: Health Sciences Authority, Ministry of Health
Spain: Spanish Agency for Medicines and Health Products
Taiwan: Department of Health, Executive Yuan, Taiwan
Thailand: Ministry of Public Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014