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History of Changes for Study: NCT04642469
Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy. (MERMAID-2)
Latest version (submitted October 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 20, 2020 None (earliest Version on record)
2 December 18, 2020 Recruitment Status, Study Status and Contacts/Locations
3 February 24, 2021 Contacts/Locations and Study Status
4 March 25, 2021 Contacts/Locations and Study Status
5 May 26, 2021 Contacts/Locations and Study Status
6 June 16, 2021 Contacts/Locations and Study Status
7 July 13, 2021 Contacts/Locations and Study Status
8 August 2, 2021 Contacts/Locations and Study Status
9 September 9, 2021 Contacts/Locations and Study Status
10 October 19, 2021 Contacts/Locations and Study Status
11 November 18, 2021 Contacts/Locations and Study Status
12 January 17, 2022 Contacts/Locations and Study Status
13 February 16, 2022 Contacts/Locations and Study Status
14 March 21, 2022 Contacts/Locations and Study Status
15 April 20, 2022 Study Status
16 May 19, 2022 Contacts/Locations and Study Status
17 June 24, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
18 August 4, 2022 Study Status and Study Design
19 October 18, 2022 Study Status, Contacts/Locations and Study Design
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Study NCT04642469
Submitted Date:  November 20, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: D910MC00001
Brief Title: Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy. (MERMAID-2)
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: March 31, 2021
Primary Completion: November 28, 2025 [Anticipated]
Study Completion: October 29, 2027 [Anticipated]
First Submitted: November 3, 2020
First Submitted that
Met QC Criteria:
November 20, 2020
First Posted: November 24, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 20, 2020
Last Update Posted: November 24, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Carcinoma, Non- Small Cell Lung
Keywords: NCSLC
Double-blind
PD-L1
MEDI4736
Durvalumab
DFS
OS
MRD+
Lung cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 284 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Durvalumab
Intravenous administration of Durvalumab
Drug: Durvalumab
Intravenous administration of Durvalumab
Other Names:
  • Medi4736
Placebo Comparator: Placebo
Intravenous administration of placebo
Placebo
Placebo Comparator
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 130 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Study Officials: David Spigel
Principal Investigator
SCRI Development Innovations, LLC
Locations: United States, California
Research Site
Los Angeles, California, United States, 90033
Research Site
Santa Rosa, California, United States, 95403
United States, Maryland
Research Site
Silver Spring, Maryland, United States, 20910
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55407
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68510
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87102
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37404
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22031
United States, Washington
Research Site
Seattle, Washington, United States, 98108-1532
Australia
Research Site
Camperdown, Australia, 2050
Research Site
Melbourne, Australia, 3000
Belgium
Research Site
Aalst, Belgium, 9300
Research Site
Hasselt, Belgium, 3500
Research Site
Kortrijk, Belgium, 8500
Research Site
Roeselare, Belgium, 8800
Czechia
Research Site
Olomouc, Czechia, 77900
Research Site
Ostrava, Czechia, 703 84
Research Site
Praha, Czechia, 140 59
Research Site
Praha 5, Czechia, 150 06
Germany
Research Site
Esslingen, Germany, 73730
Research Site
Gauting, Germany, 82131
Research Site
Göttingen, Germany, 37075
Research Site
Köln, Germany, 51109
Research Site
Münster, Germany, 48149
Research Site
Regensburg, Germany, 93049
Research Site
Würzburg, Germany, 97078
Greece
Research Site
Athens, Greece, 11526
Research Site
Athens, Greece, 11527
Research Site
Heraklion, Greece, 711 11
Research Site
Holargos, Athens, Greece, 155 62
Research Site
Larissa, Greece, 41110
Research Site
Thessaloniki, Greece, 54645
Hungary
Research Site
Szolnok, Hungary, 5004
India
Research Site
Mumbai, India, 400053
Japan
Research Site
Akashi-shi, Japan, 673-8558
Research Site
Hiroshima-shi, Japan, 734-8551
Research Site
Kashiwa, Japan, 277-8577
Research Site
Koto-ku, Japan, 135-8550
Research Site
Osaka-shi, Japan, 534-0021
Research Site
Osaka-shi, Japan, 541-8567
Research Site
Sakai-shi, Japan, 591-8555
Research Site
Sendai-shi, Japan, 980-0873
Research Site
Sunto-gun, Japan, 411-8777
Research Site
Yokohama-shi, Japan, 241-8515
Korea, Republic of
Research Site
Cheongju-si, Korea, Republic of, 28644
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 06351
Research Site
Seoul, Korea, Republic of, 06591
Research Site
Suwon, Korea, Republic of, 16247
Mexico
Research Site
Culiacan, Mexico, 80040
Research Site
Mexico, Mexico, 3240
Research Site
Monterrey, Mexico, 64465
Research Site
Nuevo Leon, Mexico, 66278
Research Site
Torreón, Mexico, 27010
Netherlands
Research Site
Breda, Netherlands, 4818 CK
Research Site
Maastricht, Netherlands, 6202 AZ
Research Site
Zwolle, Netherlands, 8025 AB
Peru
Research Site
Lima, Peru, LIMA 11
Research Site
Lima, Peru, Lima 32
Research Site
Lima, Peru, LIMA 34
Poland
Research Site
Bydgoszcz, Poland, 85-796
Research Site
Gdańsk, Poland, 80-214
Research Site
Lublin, Poland, 20-090
Research Site
Poznań, Poland, 60-569
Research Site
Tomaszów Mazowiecki, Poland, 97-200
Research Site
Warszawa, Poland, 02-781
Research Site
Wroclaw, Poland, 53-413
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Barcelona, Spain, 08041
Research Site
Madrid, Spain, 28041
Research Site
Málaga, Spain, 29010
Research Site
Oviedo, Spain, 33011
Research Site
Palma, Spain, 07198
Research Site
Pamplona, Spain, 31008
Research Site
Santiago de Compostela, Spain, 15706
Switzerland
Research Site
Lausanne, Switzerland, CH-1011
Research Site
Zürich, Switzerland, 8006
Taiwan
Research Site
Chiayi, Taiwan, 613
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan, 40201
Research Site
Tainan, Taiwan, 70403
Research Site
Taipei, Taiwan, 11217
Research Site
Taipei, Taiwan, 235
Research Site
Tao-Yuan, Taiwan, 333
Turkey
Research Site
Ankara, Turkey, 06010
Research Site
Istanbul, Turkey, 34010
Research Site
Istanbul, Turkey, 34214
Research Site
Malatya, Turkey, 44280
United Kingdom
Research Site
London, United Kingdom, SW3 6JJ
Research Site
London, United Kingdom, WC1N 3BG
Research Site
Surrey, United Kingdom, SM2 5PT
Vietnam
Research Site
Hanoi, Vietnam, 100000
Research Site
Ho Chi Minh, Vietnam, 70000
Research Site
Hochiminh, Vietnam, 70000
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
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
Open or close this module References
Citations:
Links:
Available IPD/Information:

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