A8081007 PF-02341066 Vs Pemetrexed or Docetaxel in patients with NSCLC
Research type
Research Study
Full title
Phase 3, randomized, open-label study of the efficacy and safety of PF 02341066 versus standard of care chemotherapy (Pemetrexed or Docetaxel) in patients with advanced non-small cell lung cancer (NSCLC) harboring a translocation or inversion event involving the anaplastic lymphoma kinase (ALK) gene locus
IRAS ID
35876
Contact name
Fiona Blackhall
Sponsor organisation
Pfizer Inc. 235 East 42nd Street, New York, NY 10017
Eudract number
2009-012595-27
Clinicaltrials.gov Identifier
Research summary
A8081007 is a Phase 3 trial comparing the safety and anti-tumour activity of PF-02341066 versus the standard chemotherapy agents, pemetrexed or docetaxel. The patients taking part will have advanced non-small lung cancer (NSCLC) with a specific gene profile involving the ALK gene. This specific genetic profile is relatively rare, occurring in approximately 5-7% of patients with NSCLC. PF-02341066 is a new investigational oral anti-cancer drug made by Pfizer, Inc. which inhibits the tumour activity of the ALK gene fusion. Early patient data suggests that PF-02341066 may slow cancer growth in this group of patients.Eligible Patients will have previously received one chemotherapy regimen that included a platinum drug and are now in need of further (second line) treatment. The purpose of this study is to see whether this new agent is more effective compared to the currently available chemotherapy medications, pemetrexed or docetaxel. Patients randomized (randomly allocated) to PF-02341066 will take it in tablet form twice daily. Chemotherapy is given by intravenous infusion every 21 days. Patients will receive study treatment for as long as they continue to benefit from the treatment.Other purposes of study are to see whether patients taking PF-02341066 have improved survival, a better safety profile, fewer side effects, and experience a higher quality of life (QOL) compared to the standard chemotherapy. The study is being sponsored by Pfizer, and will include a total of 318 patients across the following countries; Argentina, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Netherlands, Poland, Romania, Russia, Spain, Sweden, UK and US. Patients will undergo a number of trial related assessments including blood tests, tumour assessments, physical examinations, QOL questionnaires, ECGs, ophthalmological assessments, and will be followed up for survival for up to 18 months following completion of the study treatment.
REC name
North West - Haydock Research Ethics Committee
REC reference
09/H1010/77
Date of REC Opinion
20 Jan 2010
REC opinion
Further Information Favourable Opinion