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Clinical trial

A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132

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Last updated:30th Apr 2016
Identifier: NCT02657434

This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Actual Study Start Date: April 30, 2016
Estimated Primary Completion Date: November 30, 2019
Estimated Study Completion Date: November 30, 2019

Arm:
- Experimental:
Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
- Active Comparator: Arm B (Carboplatin or Cisplatin + Pemetrexed)

Category Value
Date last updated at source 2018-07-17
Study type(s) Interventional
Expected enrolment 568
Study start date 2016-04-30
Estimated primary completion date 2019-11-30

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