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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: BIBW 2992; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00656136

1200.23

2007-005983-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 585 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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585 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients receive placebo once daily

Treatment:

Drug: placebo

BIBW 2992

Experimental group

Description:

Patients receive BIBW 2992 tablets once daily

Treatment:

Drug: BIBW 2992