BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00949650
First received: July 29, 2009
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung Adenocarcinoma |
Drug: Pemetrexed Drug: BIBW 2992 Drug: Cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary endpoint will be progression free survival, as determined by RECIST 1.1. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response (CR, PR) according to RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Disease control (CR, PR, SD) according to RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Deterioration of body weight and ECOG performance status [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Health related quality of life (HRQOL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Pharmacokinetics of BIBW 2992 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
- Safety of BIBW 2992 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 330 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIBW 2992
BIBW 2992 tablet once daily until progression
|
Drug: BIBW 2992
BIBW 2992 once daily until progression
|
|
Active Comparator: Cisplatin/Pemetrexed
Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
|
Drug: Pemetrexed
Pemetrexed IV given once every 3 weeks for up to 6 cycles
Drug: Cisplatin
Cisplatin IV given once every 3 weeks for up to 6 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949650
Show 134 Study Locations
Show 134 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00949650 History of Changes |
| Other Study ID Numbers: | 1200.32, 2008-005615-18 |
| Study First Received: | July 29, 2009 |
| Last Updated: | January 9, 2013 |
| Health Authority: | Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Australia: Dept of Health and Ageing Therapeutic Goods Admin Austria: Medicines and Medical Devices Agency Belgium: Federal Agency for Medicinal and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Chile: Instituto de Salud Publica de Chile France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hong Kong: Department of Health Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Ethics Committee Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Malaysia: Ministry of Health Peru: Ministry of Health Philippines: Bureau of Food and Drugs Romania: National Medicines Agency Russia: Pharmacological Committee, Ministry of Health Taiwan: Department of Health Thailand: Food and Drug Administration Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Pemetrexed Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 21, 2013