Trial Identifiers
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Scientific Title
A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of RO7247669 Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Commercial Sponsor
Hoffmann-La Roche
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In Experimental Arm A, participants will receive RO7247669 + Platinum-Based Chemotherapy. Those participants with non-squamous cell (NSQ) non-small cell lung cancer (NSCLC) will receive induction treatment with blinded RO7247669 in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by maintenance therapy every 3 weeks with blinded RO7247669 together with pemetrexed. Those participants with squamous cell (SQ) NSCLC will receive blinded RO7247669 in combination with paclitaxel and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by blinded blinded RO7247669 (On Day 1) every 3 weeks.
In the Active Comparator Arm, participants will receive pembrolizumab + platinum-based chemotherapy. Those participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by maintenance therapy with blinded pembrolizumab together with pemetrexed every 3 weeks. Those participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) every 3 weeks.