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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04642469
Collaborator
(none)
22
Enrollment
119
Locations
2
Arms
35
Anticipated Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Actual Enrollment :
22 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 :
Nov 30, 2020
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Durvalumab

Intravenous administration of Durvalumab

Drug: Durvalumab
Intravenous administration of Durvalumab
Other Names:
  • Medi4736

    		•
    Placebo Comparator: Placebo

    Intravenous administration of placebo

    Other: Placebo
    Placebo Comparator

    Outcome Measures

    Primary Outcome Measures

    1. DFS in PD-L1 TC≥1% (using Investigator assessments according to RECIST 1.1) [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) [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) [Approximately 5 years]

      To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

    3. Time to first subsequent therapy (TFST) [Approximately 5 years]

      To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

    4. Time to second subsequent therapy (TSST) [Approximately 5 years]

      To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

    5. Change from baseline in EORTC QLQ-C30 [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 [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 [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 [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. [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 [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 [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 [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 [Approximately 7 years]

      To assess the efficacy of durvalumab compared to placebo as measured by OS in all randomized patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Long Beach California United States 90806
    2 Research Site Los Angeles California United States 90089
    3 Research Site Daytona Beach Florida United States 32117
    4 Research Site Gainesville Florida United States 32605
    5 Research Site Punta Gorda Florida United States 33980
    6 Research Site Louisville Kentucky United States 40241
    7 Research Site Minneapolis Minnesota United States 55404
    8 Research Site Spartanburg South Carolina United States 29303
    9 Research Site Nashville Tennessee United States 37203
    10 Research Site Salt Lake City Utah United States 84112
    11 Research Site Ciudad Autonoma De Buenos Aire Argentina C1125ABD
    12 Research Site Camperdown Australia 2050
    13 Research Site Melbourne Australia 3000
    14 Research Site St Leonards Australia 2065
    15 Research Site Hasselt Belgium 3500
    16 Research Site Roeselare Belgium 8800
    17 Research Site Barretos Brazil 14784-400
    18 Research Site Florianópolis Brazil 88034-000
    19 Research Site Porto Alegre Brazil 90610-000
    20 Research Site Vitoria Brazil 29043-260
    21 Research Site Victoria British Columbia Canada V8R 6V5
    22 Research Site Saint John New Brunswick Canada E2L 4L2
    23 Research Site Kingston Ontario Canada K7L 2V7
    24 Research Site Ottawa Ontario Canada K1H 8L6
    25 Research Site Montreal Quebec Canada H4A 3J1
    26 Research Site Olomouc Czechia 77900
    27 Research Site Ostrava Czechia 703 00
    28 Research Site Praha 2 Czechia 128 08
    29 Research Site Marseille France 13915
    30 Research Site Pessac France 33604
    31 Research Site St Herblain France 44805
    32 Research Site Strasbourg Cedex France 67091
    33 Research Site Athens Greece 11526
    34 Research Site Athens Greece 11527
    35 Research Site Heraklion Greece 711 11
    36 Research Site Holargos, Athens Greece 155 62
    37 Research Site Larissa Greece 41110
    38 Research Site Thessaloniki Greece 54645
    39 Research Site Hong Kong Hong Kong
    40 Research Site Jordan Hong Kong
    41 Research Site Budapest Hungary 1083
    42 Research Site Budapest Hungary 1121
    43 Research Site Gyöngyös - Mátraháza Hungary 3200
    44 Research Site Győr Hungary 9024
    45 Research Site Szolnok Hungary 5004
    46 Research Site Székesfehérvár Hungary 8000
    47 Research Site Törökbálint Hungary 2045
    48 Research Site Bengaluru India 560099
    49 Research Site New Delhi India 11029
    50 Research Site Haifa Israel 31096
    51 Research Site Jerusalem Israel 91120
    52 Research Site Kfar Saba Israel 4428164
    53 Research Site Petah Tikva Israel 49100
    54 Research Site Ramat-Gan Israel 52621
    55 Research Site Meldola Italy 47014
    56 Research Site Milano Italy 20133
    57 Research Site Monza Italy 20052
    58 Research Site Orbassano Italy 10043
    59 Research Site Peschiera Del Garda Italy 37019
    60 Research Site Roma Italy 00144
    61 Research Site Rozzano Italy 20089
    62 Research Site Akashi-shi Japan 673-8558
    63 Research Site Bunkyo-ku Japan 160-0023
    64 Research Site Hiroshima-shi Japan 734-8551
    65 Research Site Kashiwa Japan 277-8577
    66 Research Site Koto-ku Japan 135-8550
    67 Research Site Osaka-shi Japan 534-0021
    68 Research Site Osaka-shi Japan 541-8567
    69 Research Site Sakai-shi Japan 591-8555
    70 Research Site Sendai-shi Japan 980-0873
    71 Research Site Sunto-gun Japan 411-8777
    72 Research Site Yokohama-shi Japan 241-8515
    73 Research Site Cheongju-si Korea, Republic of 28644
    74 Research Site Seoul Korea, Republic of 05505
    75 Research Site Seoul Korea, Republic of 06351
    76 Research Site Seoul Korea, Republic of 06591
    77 Research Site Suwon Korea, Republic of 16247
    78 Research Site Breda Netherlands 4818 CK
    79 Research Site Maastricht Netherlands 6202 AZ
    80 Research Site Zwolle Netherlands 8025 AB
    81 Research Site Bellavista Peru CALLAO 2
    82 Research Site Lima Peru 0051
    83 Research Site Lima Peru Lima 32
    84 Research Site Lima Peru LIMA 34
    85 Research Site Bydgoszcz Poland 85-796
    86 Research Site Gdańsk Poland 80-214
    87 Research Site Tomaszów Mazowiecki Poland 97-200
    88 Research Site Warszawa Poland 02-781
    89 Research Site Wrocław Poland 53-413
    90 Research Site Moscow Russian Federation 105229
    91 Research Site Moscow Russian Federation 115478
    92 Research Site Novosibirsk Russian Federation 630108
    93 Research Site Saint Petersburg Russian Federation 191036
    94 Research Site Saint Petersburg Russian Federation 197758
    95 Research Site Singapore Singapore 119228
    96 Research Site Singapore Singapore 169610
    97 Research Site Singapore Singapore 308433
    98 Research Site Barcelona Spain 08035
    99 Research Site Barcelona Spain 08041
    100 Research Site Madrid Spain 28041
    101 Research Site Málaga Spain 29010
    102 Research Site Oviedo Spain 33011
    103 Research Site Pamplona Spain 31008
    104 Research Site Santiago de Compostela Spain 15706
    105 Research Site Chiayi Taiwan 613
    106 Research Site Kaohsiung Taiwan
    107 Research Site Taichung Taiwan 40201
    108 Research Site Tainan Taiwan 70403
    109 Research Site Taipei Taiwan 11217
    110 Research Site Taipei Taiwan 235
    111 Research Site Tao-Yuan Taiwan 333
    112 Research Site Adana Turkey 01120
    113 Research Site Ankara Turkey 06010
    114 Research Site Istanbul Turkey 34010
    115 Research Site Istanbul Turkey 34214
    116 Research Site Malatya Turkey 44280
    117 Research Site Hanoi Vietnam 100000
    118 Research Site Ho Chi Minh Vietnam 70000
    119 Research Site Hochiminh Vietnam 70000

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: David Spigel, SCRI Development Innovations, LLC
    • Principal Investigator: Charles Swanton, The Francis Crick Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04642469
    Other Study ID Numbers:
    • D910MC00001
    First Posted:
    Nov 24, 2020
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Carcinoma, Non-Small-Cell Lung
    Durvalumab

    Study Results

    No Results Posted as of Aug 5, 2022