Phase 3 N=585 Randomized Double-blind Treatment

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

Carcinoma, Non-Small-Cell Lung

Bottom Line

View on ClinicalTrials.gov: NCT00656136 ↗

Enrolled (actual)

585

Serious AEs

29.4%

Results posted

Nov 2013

Primary outcome: Primary: Overall Survival — 11.96; 10.78; 11.73; 10.87 Months — p=0.7428

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: placebo (Drug); BIBW 2992 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	11.96; 10.78; 11.73; 10.87	0.7428
SECONDARY Progression-free Survival (PFS)	1.08; 3.29	<0.0001 sig
SECONDARY Objective Response Rate (OR)	0.5; 7.4	0.0071 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00656136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.