Overview

This trial is active, not recruiting.

Conditions carcinoma, non-small-cell lung, adenocarcinoma
Treatments pemetrexed, bibw 2992, cisplatin
Phase phase 3
Targets EGFR, HER2, HER4
Sponsor Boehringer Ingelheim
Start date August 2009
End date January 2012
Trial size 345 participants
Trial identifier NCT00949650, 1200.32, 2008-005615-18

Summary

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BIBW 2992 tablet once daily until progression
bibw 2992
BIBW 2992 once daily until progression
(Active Comparator)
Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
pemetrexed
Pemetrexed IV given once every 3 weeks for up to 6 cycles
cisplatin
Cisplatin IV given once every 3 weeks for up to 6 cycles

Primary Outcomes

Measure
Progression-free Survival (PFS) Time
time frame: Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks or until death

Secondary Outcomes

Measure
Percentage of Patients With Objective Response (OR)
time frame: Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks
Percentage of Participants With Disease Control (DC)
time frame: Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks
Overall Survival (OS) Time
time frame: From randomisation to primary endpoint analysis cut-off date.
Tumour Shrinkage
time frame: Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks
Change From Baseline in Body Weight
time frame: Baseline and throughout the trial until progression (every 3 weeks), up to 28 month
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
time frame: Throughout the trial until progression (every 3 weeks), up to 28 month
Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing
time frame: Throughout the trial until progression (every 3 weeks)
HRQOL: Time to Deterioration in Dyspnoea
time frame: Throughout the trial until progression (every 3 weeks)
HRQOL: Time to Deterioration in Pain
time frame: Throughout the trial until progression (every 3 weeks)
Trough Plasma Concentrations of Afatinib at Day 22
time frame: Day 22
Trough Plasma Concentrations of Afatinib at Day 29
time frame: Day 29
Trough Plasma Concentrations of Afatinib at Day 43
time frame: Day 43

Eligibility Criteria

Male or female participants at least 18 years old.

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. - Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material. - Measurable disease according to RECIST 1.1. - Eastern Cooperative Oncology Group score of 0 or 1. - Age >/= 18 years. - Life expectancy of at least three 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 Epidermal Growth Factor Receptor 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 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 absolute neutrophil count and platelet count - Adequate liver and kidney function - Active hepatitis B infection, active hepatitis C infection or known HIV carrier.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.