Skip to main content
OpenTrials
Completed

NCT Number: NCT00656136

BIBW 2992 and BSC Versus Placebo and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1200.23.32004 Boehringer Ingelheim Investigational Site, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
  • Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
  • 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
  • Male and female patients age >18 years
  • Life expectancy of at least three (3) months
  • Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria

  • Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
  • Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
  • Active brain metastases
  • Significant or recent acute gastrointestinal disorders with diarrhea
  • Patients who have any other life-threatening illness or organ system dysfunction,
  • Other malignancies diagnosed within the past five (5) years
  • Radiotherapy within the past 2 weeks prior to treatment
  • History of clinically significant or uncontrolled cardiac disease
  • Adequate ANC and platelet count
  • Adequate liver and kidney function
  • Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C

Treatment and study plan

Placebo

Drug

Patients receive placebo once daily

BIBW 2992

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2008
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.