Clinical Trials /

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)

NCT04385368

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
Durvalumab + SoC chemotherapyMEDI4736Durvalumab + 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

NameTypeDescriptionInterventions
Durvalumab + SoC chemotherapyExperimentalIntravenous administration of Experimental and Standard of Care Therapy
  • Durvalumab + SoC chemotherapy
Placebo + SoC chemotherapyPlacebo ComparatorIntravenous 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:Concentration of durvalumab
    Time Frame:Approximately 4 years
    Safety Issue:
    Description:To assess the PK of durvalumab
    Measure:Presence of ADAs for durvalumab
    Time Frame:Approximately 4 years
    Safety Issue:
    Description:To investigate the immunogenicity of durvalumab
    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:Not yet recruiting
    Lead Sponsor:AstraZeneca

    Trial Keywords

    • NCSLC
    • Double-blind
    • PD-L1
    • MEDI4736
    • Durvalumab
    • DFS
    • OS
    • MRD+
    • MRD-
    • Completely Resected Lung Cancer

    Last Updated

    May 7, 2020