A Study to Investigate the Efficacy of Durvalumab plus Tremelimumab in combination with Chemotherapy compared with Pembrolizumab in combination with Chemotherapy in metastatic Non-Small Cell Lung Cancer (NSCLC) Patients - TRITON

Study identifier:D419ML00003

ClinicalTrials.gov identifier:NCT06008093

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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).

Medical condition

Carcinoma, Non-Small-Cell Lung

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Tremelimumab, Pemetrexed, Pembrolizumab, Carboplatin, Cisplatin

Sex

All

Estimated Enrollment

280

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Mar 2024
Estimated Primary Completion Date: 17 Aug 2027
Estimated Study Completion Date: 05 Mar 2031

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria