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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 : October 19, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 3, 2020
First Posted Date  ICMJE November 24, 2020
Last Update Posted Date October 19, 2022
Actual Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • 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
  • PFS (using local standard practice) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes
  • Time to first subsequent therapy (TFST) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes
  • Time to second subsequent therapy (TSST) [ Time Frame: Approximately 5 years ]
    To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
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 Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
Official Title  ICMJE 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.
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.
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 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
    Intravenous administration of Durvalumab
    Other Name: Medi4736
  • Other: Placebo
    Placebo Comparator
Study Arms  ICMJE
  • Experimental: Durvalumab
    Intravenous administration of Durvalumab
    Intervention: Drug: Durvalumab
  • Placebo Comparator: Placebo
    Intravenous administration of placebo
    Intervention: Other: Placebo
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 18, 2022)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2020)
284
Estimated Study Completion Date  ICMJE October 31, 2023
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   France,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United States,   Vietnam
Removed Location Countries Bulgaria,   Denmark,   Germany,   Mexico,   Romania,   Sweden,   Switzerland,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT04642469
Other Study ID Numbers  ICMJE D910MC00001
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
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
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Spigel SCRI Development Innovations, LLC
Principal Investigator: Charles Swanton The Francis Crick Institute
PRS Account AstraZeneca
Verification Date October 2022

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