Trial Identifiers
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Scientific Title
A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
Commercial Sponsor
Hoffmann-La Roche
Summary
Eligible participants will be assigned to one of two experimental cohorts. Experimental Cohort A will recruit participants with high programmed death-ligand 1 (PD-L1) expressing cancer, and they will receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical removal of the cancer and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator. Experimental Cohort B will recruit participants with any PD-L1 expression level and they will receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles. Atezolizumab (1200mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle. Tiragolumab (600mg) will be administered by IV infusion on Day 1 of each 21-day cycle.
Chemotherapy may include: cisplatin/carboplatin + pemetrexed (for non-squamous only), cisplatin/carboplatin + gemcitabine (for squamous only), or carboplatin + paclitaxel.