Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    d910lc00001
Previous Study | Return to List | Next Study

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)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385368
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 12, 2020
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE July 17, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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
  • 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
  • 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
  • Concentration of durvalumab [ Time Frame: Approximately 4 years ]
    To assess the PK of durvalumab
  • Presence of ADAs for durvalumab [ Time Frame: Approximately 4 years ]
    To investigate the immunogenicity of durvalumab
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double- Blind
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Durvalumab + SoC chemotherapy
    Experimental Treatment
    Other Name: MEDI4736
  • Other: Placebo + SoC chemotherapy
    Placebo Comparator
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Durvalumab + SoC chemotherapy
    Intravenous administration of Experimental and Standard of Care Therapy
    Intervention: Drug: Durvalumab + SoC chemotherapy
  • Placebo Comparator: Placebo + SoC chemotherapy
    Intravenous administration of Placebo and Standard of Care Therapy
    Intervention: Other: Placebo + SoC chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
332
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2026
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04385368
Other Study ID Numbers  ICMJE D910LC00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Solange Peters Centre Hospitalier Universitaire Vaudois (CHUV)
Principal Investigator: Charles Swanton The Francis Crick Institute
PRS Account AstraZeneca
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP