A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-003292-42

Femme et Homme

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Extrait

Part 1: To identify a dose of AMG 479 in combination with etoposide plus carboplatin and/or etoposide plus cisplatin and of AMG 102 in combination with etoposide plus carboplatin and/or etoposide plus cisplatin that can be administered safely and is tolerated as determined by the incidence of dose-limiting toxicity (DLT) Part 2: To estimate the relative treatment effect of AMG 479 (at the dose selected in Part 1) in combination with chemotherapy (etoposide plus carboplatin and/or etoposide plus cisplatin, as determined in part 1), and of AMG 102 (at the dose selected in Part 1) in combination with chemotherapy, compared with placebo plus chemotherapy, as measured by the respective hazard ratios (HR) for overall survival (OS).


Critère d'inclusion

  • Previously Untreated Extensive Stage Small Cell Lung Cancer (SCLC)