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Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy. (MERMAID-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642469
Recruitment Status : Active, not recruiting
First Posted : November 24, 2020
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non- Small Cell Lung Drug: Durvalumab Other: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
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.
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : April 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Durvalumab
Intravenous administration of Durvalumab
 Drug: Durvalumab
Intravenous administration of Durvalumab
Other Name: Medi4736
Placebo Comparator: Placebo
Intravenous administration of placebo
 Other: Placebo
Placebo Comparator


Outcome Measures
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Primary Outcome Measures :
  1. DFS in PD-L1 TC≥1% (using Investigator assessments according to RECIST 1.1) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set


Secondary Outcome Measures :
  1. DFS in FAS (using Investigator assessments according to RECIST 1.1) [ Time Frame: approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients

  2. PFS (using local standard practice) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

  3. Time to first subsequent therapy (TFST) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

  4. Time to second subsequent therapy (TSST) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

  5. Change from baseline in EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo

  6. Change from baseline in EORTC QLQ-LC13 [ Time Frame: Approximately 5 years ]
    To assess patient-reported symptoms, functioning,and HRQoL in patients treated with durvalumab compared to placebo

  7. Time to deterioration in EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo

  8. Time to deterioration in EORTC QLQ-LC13 [ Time Frame: Approximately 5 years ]
    To assess patient-reported symptoms, functioning,and HRQoL in patients treated with durvalumab compared to placebo

  9. 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 ]
    To investigate the relationship between a patient's baseline PD-L1 TC expression and efficacy of study treatments

  10. DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC≥1% analysis set [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set

  11. DFS (using BICR assessments according to RECIST 1.1) in FAS [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients.

  12. OS in PD-L1 TC≥1% analysis set [ Time Frame: Approximately 7 years ]
    To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC≥1% analysis set

  13. OS in FAS [ Time Frame: Approximately 7 years ]
    To assess the efficacy of durvalumab compared to placebo as measured by OS in all randomized patients


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642469


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: David Spigel SCRI Development Innovations, LLC
Principal Investigator: Charles Swanton Francis Crick Institute
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04642469    
Other Study ID Numbers: D910MC00001
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
NCSLC
Double-blind
PD-L1
MEDI4736
Durvalumab
 DFS
OS
MRD+
Lung cancer
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents