Clinical Trials /

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

NCT04642469

Description:

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

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

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04642469

Trial Eligibility

Document

Title

  • Brief Title: Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
  • Official Title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.

Clinical Trial IDs

  • ORG STUDY ID: D910MC00001
  • NCT ID: NCT04642469

Conditions

  • Carcinoma, Non- Small Cell Lung

Interventions

DrugSynonymsArms
DurvalumabMedi4736Durvalumab

Purpose

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

Detailed Description

      This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to
      evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in
      patients with completely resected stage II-III NSCLC who have undergone curative intent
      therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of
      Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence,
      and who become MRD+ during a 96-week surveillance period.

Trial Arms

NameTypeDescriptionInterventions
DurvalumabExperimentalIntravenous administration of Durvalumab
  • Durvalumab
PlaceboPlacebo ComparatorIntravenous administration of placebo

    Eligibility Criteria

            Inclusion Criteria:

          1. Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the ICFs and in the protocol.

          2. Age ≥18 years at the time of screening (ICF1);

          3. Histologically confirmed NSCLC with resectable stage II-III disease

          4. Complete resection of the primary NSCLC

        Exclusion Criteria:

          1. EGFR and/or ALK mutant

          2. Mixed small cell and NSCLC histology

          3. History of allogeneic organ or bone marrow transplantation

          4. History of active primary immunodeficiency
    Maximum Eligible Age:130 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:DFS in PD-L1 TC≥1% (using Investigator assessments according to RECIST 1.1)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set

    Secondary Outcome Measures

    Measure:DFS in FAS (using Investigator assessments according to RECIST 1.1)
    Time Frame:approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients
    Measure:PFS (using local standard practice)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes
    Measure:Time to first subsequent therapy (TFST)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes
    Measure:Time to second subsequent therapy (TSST)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes
    Measure:Change from baseline in EORTC QLQ-C30
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo
    Measure:Change from baseline in EORTC QLQ-LC13
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess patient-reported symptoms, functioning,and HRQoL in patients treated with durvalumab compared to placebo
    Measure:Time to deterioration in EORTC QLQ-C30
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo
    Measure:Time to deterioration in EORTC QLQ-LC13
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess patient-reported symptoms, functioning,and HRQoL in patients treated with durvalumab compared to placebo
    Measure:IHC analysis of PD-L1 TC expression and spatial distribution within the tumor microenvironment relative to efficacy outcomes (ie, DFS, OS)The Ventana SP263 PD-L1 immunohistochemistry (IHC) assay will be used to determine PDL1 status in all specimens.
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To investigate the relationship between a patient's baseline PD-L1 TC expression and efficacy of study treatments
    Measure:DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC≥1% analysis set
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set
    Measure:DFS (using BICR assessments according to RECIST 1.1) in FAS
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients.
    Measure:OS in PD-L1 TC≥1% analysis set
    Time Frame:Approximately 7 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC≥1% analysis set
    Measure:OS in FAS
    Time Frame:Approximately 7 years
    Safety Issue:
    Description:To assess the efficacy of durvalumab compared to placebo as measured by OS in all randomized patients

    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+
    • Lung cancer

    Last Updated

    August 3, 2021