Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Stage I-III Limited Disease Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Official Title

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Stage I-III Limited Disease Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

Summary:

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Stage I-III LD-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Trial Description

Primary Outcome:

• Progression-free survival (PFS)
• Overall Survival (OS)

• Overall Survival (OS)
• Objective Response Rate (ORR)
• Progression-free survival PFS
• Progression-free survival at 18 months (PFS18)
• Progression-free survival at 24 months (PFS24)
• Time to death or distant metastasis (TTDM)
• Proportion of patients alive at 24 months (OS24)
• Proportion of patients alive at and 36 months (OS36)
• Time from randomization to second progression (PFS2)
• To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3
• To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration)
• Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative)
• To assess a relationship between a tumour mutational burden (TMB) measured as biomarker presence in tumour and/or blood and Progression-free survival (PFS) with durvalumab and durvalumab and tremelimumab combination therapy
• To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13
• To assess a relationship between a tumour mutational burden (TMB) measured as biomarker presence in tumour and/or blood and Objective Response Rate (ORR) with durvalumab and durvalumab and tremelimumab combination therapy
• To assess a relationship between a tumour mutational burden (TMB) measured as biomarker presence in tumour and/or blood and Overall Survival (OS) with durvalumab and durvalumab and tremelimumab combination therapy

View this trial on ClinicalTrials.gov