Study identifier:D419ML00003
ClinicalTrials.gov identifier:NCT06008093
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IIIb, Randomized, Multicenter, Open-label Study to assess the Efficacy of Durvalumab plus Tremelimumab versus Pembrolizumab in Combination with Platinum-Based Chemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Non-Squamous Histology who have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON).
Carcinoma, Non-Small-Cell Lung
Phase 3
No
Durvalumab, Tremelimumab, Pemetrexed, Pembrolizumab, Carboplatin, Cisplatin
All
280
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm A: Durvalumab + Tremelimumab + Platinum-based Chemotherapy Participants will receive durvalumab plus tremelimumab q3w for four 21-day cycles in combination with chemotherapy followed by maintenance therapy (durvalumab plus pemetrexed maintenance) every 4 weeks (q4w) until disease progression or unacceptable toxicity or treatment discontinuation. During the maintenance therapy phase, participants will receive an additional cycle of durvalumab plus tremelimumab (plus pemetrexed, where applicable) at Week 16. | Drug: Durvalumab Participants will receive intravenous (IV) Durvalumab q3w for four 21-day cycles. Durvalumab will also be given during the maintenance phase q4w until disease progression or unacceptable toxicity and at week 16. Drug: Tremelimumab Participants will receive IV Tremelimumab q3w for four 21-day cycles. Tremelimumab will also be given during the maintenance therapy phase at week 16. Drug: Pemetrexed Participants will receive IV pemetrexed q3w for four 21-day cycles and q4w until disease progression or unacceptable toxicity. During the maintenance therapy phase, participants may receive an additional cycle of pemetrexed, where applicable, at Week 16. Other Name: Background Platinum-based Chemotherapy Drug: Carboplatin Participants will receive IV Carboplatin on Day 1 of each 21-day cycle for 4 cycles. Other Name: Background Platinum-based Chemotherapy Drug: Cisplatin Participants will receive IV Cisplatin on Day 1 of each 21-day cycle for 4 cycles. Other Name: Background Platinum-based Chemotherapy |
Experimental: Arm B: Pembrolizumab + Platinum-based Chemotherapy Participants will receive pembrolizumab regimen q3w for four 21-day cycles in combination with chemotherapy followed by maintenance therapy (pembrolizumab plus pemetrexed maintenance) q3w until disease progression or unacceptable toxicity for up to 24 months or treatment discontinuation. | Drug: Pembrolizumab Participants will receive IV pembrolizumab q3w for four 21-day cycles and q3w until disease progression or unacceptable toxicity for up to 24 months. Drug: Carboplatin Participants will receive IV Carboplatin on Day 1 of each 21-day cycle for 4 cycles. Other Name: Background Platinum-based Chemotherapy Drug: Cisplatin Participants will receive IV Cisplatin on Day 1 of each 21-day cycle for 4 cycles. Other Name: Background Platinum-based Chemotherapy Drug: Pemetrexed Participants will receive IV pemetrexed q3w for four 21-day cycles and q3w until disease progression or unacceptable toxicity for up to 24 months. Other Name: Background Platinum-based Chemotherapy |