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Trial record 1 of 1 for:    NCT04385368
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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) (MERMAID-1)

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ClinicalTrials.gov Identifier: NCT04385368
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
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

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 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 to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (Mermaid-1)
Actual Study Start Date : July 17, 2020
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : September 29, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Durvalumab + SoC chemotherapy
Intravenous administration of Experimental and Standard of Care Therapy
Drug: Durvalumab + SoC chemotherapy
Experimental Treatment
Other Name: MEDI4736

Placebo Comparator: Placebo + SoC chemotherapy
Intravenous administration of Placebo and Standard of Care Therapy
Other: Placebo + SoC chemotherapy
Placebo Comparator
Other Name: Placebo




Primary Outcome Measures :
  1. Disease free survival (DFS) in MRD+ analysis set (using Investigator assessments according to RECIST 1.1) [ Time Frame: approximately 4 years ]
    To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients


Secondary Outcome Measures :
  1. DFS in FAS (using Investigator assessments according to RECIST 1.1) [ Time Frame: Approximately 4 years ]
    To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in all patients

  2. DFS (using BICR assessments according to RECIST 1.1) in MRD+ analysis set and in FAS [ Time Frame: Approximately 4 years ]
    To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients and in all patients

  3. OS in MRD+ analysis set and in FAS [ Time Frame: Approximately 6 years ]
    To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by OS in MRD+ patients and in all patients

  4. Concentration of durvalumab [ Time Frame: Approximately 4 years ]
    To assess the PK of durvalumab

  5. Presence of ADAs for durvalumab [ Time Frame: Approximately 4 years ]
    To investigate the immunogenicity of durvalumab

  6. Change from baseline in EORTC QLQ-LC13 score [ Time Frame: Approximately 4 years ]
    To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy

  7. Time to deterioration in EORTC QLQ-LC13 score [ Time Frame: Approximately 4 years ]
    To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy

  8. Change from baseline in EORTC QLQ-C30 score [ Time Frame: Approximately 4 years ]
    To assess patient-reported symptoms, functioning and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy

  9. Time to deterioration in EORTC QLQ-C30 score [ Time Frame: Approximately 4 years ]
    To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy



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 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

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): NCT04385368


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Solange Peters Centre Hospitalier Universitaire Vaudois (CHUV)
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04385368    
Other Study ID Numbers: D910LC00001
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AstraZeneca:
NCSLC
Double-blind
PD-L1
MEDI4736
Durvalumab
DFS
OS
MRD+
MRD-
Completely Resected 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