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Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Pemetrexed and Cisplatin plus Enzastaurin versus Pemetrexed and Cisplatin plus Placebo in Chemonaive Patients with Advanced, Unresectable...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-005306-31

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Pemetrexed and Cisplatin plus Enzastaurin versus Pemetrexed and Cisplatin plus Placebo in Chemonaive Patients with Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer

Femme et Homme

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Extrait

The study will be conducted in 2 parts: • Part 1: a single-arm, unblinded, safety lead in. • Part 2: a multiple-site, randomized, double-blind, placebo-controlled study. The objective of the Safety lead in, Part1, is to evaluate the safety of enzastaurin plus pemetrexed and cisplatin in the first-line treatment of patients with advanced, unresectable (stage IIIB) or metastatic (Stage IV) both squamous and nonsquamous NSCLC The objective of Part 2 (randomized, double-blind, placebo-controlled, phase 2 study) is to compare first-line treatment with pemetrexed and cisplatin plus enzastaurin versus pemetrexed and cisplatin plus placebo, followed by maintenance enzastastaurin or placebo, in terms of progression-free survival (PFS), in patients with advanced, unresectable or metastatic nonsquamous NSCLC

Critère d'inclusion

  • advanced, unresectable, or metastatic (stage IIIB or IV) nonsquamous non-small cell lung cancer

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