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A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination with Pemetrexed (Alimta®) versus Pemetrexed alone in P...

Update Il y a 4 ans
Reference: EUCTR2006-003695-35

A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination with Pemetrexed (Alimta®) versus Pemetrexed alone in Patients with Locally-Advanced or Metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of 1st Line Anti-cancer Therapy

Woman and Man

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Extract

The primary objective of this study is to demonstrate an improvement in PFS as assessed by RECIST criteria, for the combination of ZD6474 plus pemetrexed (Alimta®) compared with pemetrexed plus placebo in patients with locally advanced or metastatic NSCLC after failure of 1st line anti-cancer therapy (not including an adjuvant regimen).

Inclusion criteria

  • Locally-advanced or Metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC)

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