Status:
COMPLETED
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 objective...
Eligibility Criteria
Inclusion
- 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 International Conference on Harmonisation-Good Clinical Practice 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.
Exclusion
Key Trial Info
Start Date :
August 14 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2017
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00949650
Start Date
August 14 2009
End Date
March 16 2017
Last Update
April 6 2018
Active Locations (133)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Clinical Trials and Research Associates Inc
Montebello, California, United States, 90640
3
Innovative Medical Research of South Florida
Miami, Florida, United States, 33179
4
Crescent City Research Consortiom
Marrero, Louisiana, United States, 70072