Description:
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
Title
- Brief Title: 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)
- Official Title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)
Clinical Trial IDs
- ORG STUDY ID:
D910LC00001
- NCT ID:
NCT04385368
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab + SoC chemotherapy | MEDI4736 | Durvalumab + SoC chemotherapy |
Purpose
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 in terms of DFS measured in MRD+ patients.
Trial Arms
Name | Type | Description | Interventions |
---|
Durvalumab + SoC chemotherapy | Experimental | Intravenous administration of Experimental and Standard of Care Therapy | - Durvalumab + SoC chemotherapy
|
Placebo + SoC chemotherapy | Placebo Comparator | Intravenous administration of Placebo and Standard of Care Therapy | |
Eligibility Criteria
Inclusion Criteria:
1. Capable of giving signed informed consent, which includes a mandatory genetic informed
consent and compliance with the requirements and restrictions listed in the informed
consent forms (ICFs) and study protocol
2. Age ≥18 years at the time of screening
3. Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable
(stage II-III) disease
4. Complete resection of the primary NSCLC
Exclusion Criteria:
1. Postoperative imaging demonstrating unequivocal evidence of disease recurrence or
tissue biopsy-proven disease recurrence
2. EGFR-mutant and/or ALK-translocation
3. Mixed small cell and NSCLC histology
4. Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab
Maximum Eligible Age: | 130 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease free survival (DFS) in MRD+ analysis set (using Investigator assessments according to RECIST 1.1) |
Time Frame: | approximately 4 years |
Safety Issue: | |
Description: | To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients |
Secondary Outcome Measures
Measure: | DFS in FAS (using Investigator assessments according to RECIST 1.1) |
Time Frame: | Approximately 4 years |
Safety Issue: | |
Description: | To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in all patients |
Measure: | DFS (using BICR assessments according to RECIST 1.1) in MRD+ analysis set and in FAS |
Time Frame: | Approximately 4 years |
Safety Issue: | |
Description: | To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients and in all patients |
Measure: | OS in MRD+ analysis set and in FAS |
Time Frame: | Approximately 6 years |
Safety Issue: | |
Description: | To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by OS in MRD+ patients and in all patients |
Measure: | Change from baseline in EORTC QLQ-LC13 score |
Time Frame: | Approximately 4 years |
Safety Issue: | |
Description: | To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy |
Measure: | Time to deterioration in EORTC QLQ-LC13 score |
Time Frame: | Approximately 4 years |
Safety Issue: | |
Description: | To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy |
Measure: | Change from baseline in EORTC QLQ-C30 score |
Time Frame: | Approximately 4 years |
Safety Issue: | |
Description: | To assess patient-reported symptoms, functioning and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy |
Measure: | Time to deterioration in EORTC QLQ-C30 score |
Time Frame: | Approximately 4 years |
Safety Issue: | |
Description: | To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- NCSLC
- Double-blind
- PD-L1
- MEDI4736
- Durvalumab
- DFS
- OS
- MRD+
- MRD-
- Completely Resected Lung Cancer
Last Updated
August 3, 2021