Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Other: Placebo + SoC chemotherapy
- Registration Number
- NCT04385368
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery
- Detailed Description
Patients who have no evidence of disease recurrence confirmed by CT and/or MRI and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab + Standard of care (SoC) chemotherapy or placebo + Standard of care (SoC) chemotherapy arm.
The primary objective of this study is to assess the efficacy of durvalumab +SoC chemotherapy compared to placebo+ SoC chemotherapy as measured by DFS in all patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + SoC chemotherapy Placebo + SoC chemotherapy Intravenous administration of Placebo and Standard of Care Therapy Durvalumab + SoC chemotherapy Durvalumab + SoC chemotherapy Intravenous administration of Experimental and Standard of Care Therapy
- Primary Outcome Measures
Name Time Method Disease-free Survival (DFS) in FAS (Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1]) Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months DFS was defined as the time from the date of randomization until either of the following events, whichever occurred first: disease recurrence using Investigator RECIST 1.1 assessments (i.e., local or regional recurrence, distant recurrence, second primary NSCLC) or death from any cause.
- Secondary Outcome Measures
Name Time Method DFS in Minimal Residual Disease-positive (MRD+) Analysis Set (Using Investigator Assessments According to RECIST 1.1) Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months DFS was defined as the time from the date of randomization until either of the following events, whichever occurred first: disease recurrence using Investigator RECIST 1.1 assessments (i.e., local or regional recurrence, distant recurrence, second primary NSCLC) or death from any cause.
OS in FAS From the date of randomization until death due to any cause, up to 35 months OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
Overall Survival (OS) in MRD+ Analysis Set From the date of randomization until death due to any cause, up to 35 months OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
Trial Locations
- Locations (1)
Research Site
🇻🇳Ho Chi Minh, Vietnam