A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin ...

Update Il y a 4 ans
Reference: EUCTR2008-002155-24

A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non Small Cell Lung Cancer

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Extract

The primary objective of this study is to compare maintenance therapy with pemetrexed plus best supportive care (BSC) versus placebo plus BSC, in terms of objective progression-free survival (PFS) time in patients with Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV non squamous NSCLC whose disease has not progressed during 4 cycles of pemetrexed + cisplatin induction chemotherapy.


Inclusion criteria

  • Advanced Non-Squamous Non Small Cell Lung cancer