A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05211895
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 860
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Durvalumab + Placebo Placebo Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months Arm A: Durvalumab + Domvanalimab Durvalumab Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months Arm B: Durvalumab + Placebo Durvalumab Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months Arm A: Durvalumab + Domvanalimab Domvanalimab Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to 8 years after randomization Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to 8 years after randomization Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1%
Objective Response Rate (ORR) Approximately 8 years after randomization Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Duration of Response (DoR) Approximately 8 years after randomization Duration of Response (DoR) using BICR assessment according to RECIST 1.1
Time from randomization to second progression (PFS2) Approximately 8 years after randomization Time from randomization to second progression (PFS2)
Time to first subsequent therapy (TFST) Approximately 8 years after randomization Time to first subsequent therapy (TFST)
Time to deterioration in pulmonary symptoms (TTFCD) Approximately 8 years after randomization Time to deterioration in pulmonary symptoms (TTFCD)
PFS investigator Up to 8 years after randomization Defined as time from randomisation until progression per RECIST 1.1 as assessed by Investigator or death due to any cause in participants
Overall Survival (OS) Approximately 8 years after randomization Overall Survival (OS)
Concentration of Durvalumab and Domvanalimab Approximately 12 weeks after last IP dose The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration
PFS6, PFS12, PFS18, PFS24 Approximately 6, 12, 18 and 24 months after randomization PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier)
Anti-Drug Antibodies (ADAs) Approximately 12 weeks after last IP dose. The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs)
Time from randomization to first date of distant metastasis or death (TTDM) Approximately 8 years after randomization Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).
OS 24 Approximately 24 months after randomization Overall Survival (OS) at 24 months
Trial Locations
- Locations (1)
Research Site
🇬🇧Nottingham, United Kingdom