BIBW 2992 Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation


Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: July 29, 2009)		The primary endpoint will be progression free survival, as determined by RECIST 1.1. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00949650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 29, 2009)		Objective response (CR, PR) and Disease control (CR, PR, SD) according to RECIST 1.1, Overall survival, Deterioration of body weight and ECOG performance status, Health related quality of life (HRQOL), Pharmacokinetics of BIBW 2992, Safety of BIBW 2992 [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEBIBW 2992 Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Official Title  ICMJELUX LUNG 3; A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Brief Summary

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an EGFR activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992 (Arm A) with Pemetrexed/Cisplatin chemotherapy (Arm B) as first line treatment for this group of patients.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
Intervention  ICMJE
  • Drug: BIBW 2992
  • Drug: Pemetrexed
  • Drug: Cisplatin

Recruitment Information

Estimated Enrollment  ICMJE330
Completion Date 
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
  • EGFR mutation detected by central laboratory analysis of tumour biopsy material.
  • Measurable disease according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Age >/= 18 years.
  • Life expectancy of at least three (3) months.
  • Written informed consent that is consistent with ICH-GCP guidelines.

Exclusion Criteria:

  • Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
  • Prior treatment with EGFR targeting small molecules or antibodies.
  • Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
  • Active brain metastases
  • Any other current malignancy or malignancy diagnosed within the past five (5) years
  • Known pre-existing interstitial lung disease.
  • Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  • History or presence of clinically relevant cardiovascular abnormalities.
  • Any other concomitant serious illness or organ system dysfunction.
  • Adequate ANC and platelet count
  • Adequate liver and kidney function
  • Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   Taiwan,   Thailand,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00949650
Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1200.32, EUDRACT 2008-005615-18
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals