A8081014 - NON-SQUAMOUS CARCINOMA Final Amendment-2 20 December 2010
Research type
Research Study
Full title
PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
IRAS ID
63844
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
Pfizer Inc 235 East 42nd Street, New York, NY10017
Eudract number
2010-021336-33
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
Crizotinib is new investigational oral anti cancer drug made by a Pfizer Inc. Early patient data suggests that Crizotinib may inhibit the tumour activity of the ALK gene fusion. This specific genetic profile is relatively rare, occurring in approximately 40,000 patients per year worldwide in patients with advanced non small lung cancer (NSCLC). Collection, of studies that archived NSCLC specimens across broad ethnic patients indicated that the incidence of ALK gene rearrangements ranged from 2-7%.This study will evaluate the benefit of crizotinib in the targeted therapy to provide a possible alternative therapeutic option, and one that may be better tolerated than standard first line chemotherapy, for patients with NSCLC harbouring ALK gene rearrangements.A total of 334 eligible patients in need of treatment will be randomized in a 1:1 ratio to receive crizotinib (Arm A) or chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin; Arm B). The choice of the platin chemotherapy will be made by the investigator.Other purposes of study are to see whether patients taking Crizotinib have improved survival, a better safety profile, fewer side effects, and experience a higher quality of life (QOL) compared to the standard chemotherapy
REC name
North West - Haydock Research Ethics Committee
REC reference
11/NW/0036
Date of REC Opinion
9 May 2011
REC opinion
Further Information Favourable Opinion