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...

Update Il y a 5 ans
Reference: EUCTR2010-021336-33

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

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Extract

To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) (Arm B), in prolonging PFS in patients with advanced nonsquamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK gene locus.


Inclusion criteria

  • Non small cell lung cancer (NSCLC)