A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05221840
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 999
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Durvalumab and Monalizumab Placebo Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only Arm A: Durvalumab and Oleclumab Oleclumab Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months Arm C: Durvalumab and Placebo Durvalumab Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months Arm C: Durvalumab and Placebo Placebo Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months Arm A: Durvalumab and Oleclumab Durvalumab Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months Arm B: Durvalumab and Monalizumab Durvalumab Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only Arm B: Durvalumab and Monalizumab Monalizumab Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
- Primary Outcome Measures
Name Time Method Progression Free Surival (PFS) Up to 5 years after first patient randomized. Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) at 6, 12, 18, and 24 months From date of randomization until 24 months Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR
Overall Survival (OS) Up to 9 years after first patient randomized Overall survival (OS)
Objective response rate (ORR) Up to 5 years after first patient randomized Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Time from randomization to first date of distant metastasis or death (TTDM) Up to 5 years after first patient randomized Time from randomization to first date of distant metastasis or death (TTDM)
Progression free survival (PFS) as assessed by Investigator Up to 5 years after first patient randomized Progression free survival (PFS) as assessed by Investigator
Concentration of Durvalumab From date of randomization until 3 months after date of last IP dose To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations
Duration of response (DoR) Up to 5 years after first patient randomized Duration of response (DoR) per RECIST 1.1 as assessed by BICR
Time from randomization to second progression (PFS2) Up to 5 years after first patient randomized Time from randomization to second progression (PFS2)
Anti-drug antibodies (ADAs) From date of randomization until 3 months after date of last IP dose The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs)
Time to deterioration in pulmonary symptoms (TTFCD) Up to 5 years after last patient randomized Time to deterioration in pulmonary symptoms (TTFCD)
Overall survival (OS) at 24 months Up to 9 years after first patient randomized Overall survival (OS) at 24 months
Time from randomization to start date of first subsequent therapy (TFST) Up to 9 years after first patient randomized Time from randomization to start date of first subsequent therapy (TFST)
IHC analysis of PD-L1 TC expression Up to 5 years after first patient randomized IHC analysis of PD-L1 TC expression relative to efficacy outcomes
Concentration of Oleclumab From date of randomization until 3 months after last dose of IP To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations
Concentration of Monalizumab From date of randomization until 3 months after last dose of IP To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations
Trial Locations
- Locations (1)
Research Site
🇻🇳Ho Chi Minh, Vietnam