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MERMAID-1: 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)

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04385368
Collaborator
(none)
89
Enrollment
148
Locations
2
Arms
39.5
Anticipated Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
89 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 :
Jul 17, 2020
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Durvalumab + SoC chemotherapy

Intravenous administration of Experimental and Standard of Care Therapy

Drug: Durvalumab + SoC chemotherapy
Experimental Treatment
Other Names:
  • MEDI4736

    		•
    Placebo Comparator: Placebo + SoC chemotherapy

    Intravenous administration of Placebo and Standard of Care Therapy

    Other: Placebo + SoC chemotherapy
    Placebo Comparator
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease free survival (DFS) in MRD+ analysis set (using Investigator assessments according to RECIST 1.1) [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) [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 [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 [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. Change from baseline in EORTC QLQ-LC13 score [Approximately 4 years]

      To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy

    5. Time to deterioration in EORTC QLQ-LC13 score [Approximately 4 years]

      To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy

    6. Change from baseline in EORTC QLQ-C30 score [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-C30 score [Approximately 4 years]

      To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy

    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States 35294
    2 Research Site Long Beach California United States 90806
    3 Research Site Santa Rosa California United States 95403
    4 Research Site West Hollywood California United States 90048
    5 Research Site Miami Florida United States 33136
    6 Research Site Silver Spring Maryland United States 20910
    7 Research Site Minneapolis Minnesota United States 55407
    8 Research Site Lincoln Nebraska United States 68510
    9 Research Site Albuquerque New Mexico United States 87131
    10 Research Site New York New York United States 10032
    11 Research Site Durham North Carolina United States 27710
    12 Research Site Spartanburg South Carolina United States 29303
    13 Research Site Sioux Falls South Dakota United States 57105
    14 Research Site Houston Texas United States 77090
    15 Research Site Seattle Washington United States 98108-1532
    16 Research Site Rosario Argentina S2000CVB
    17 Research Site Camperdown Australia 2050
    18 Research Site St Leonards Australia 2065
    19 Research Site Aalst Belgium 9300
    20 Research Site Bruxelles Belgium 1200
    21 Research Site Hasselt Belgium 3500
    22 Research Site Leuven Belgium 3000
    23 Research Site Roeselare Belgium 8800
    24 Research Site Belo Horizonte Brazil 30110-022
    25 Research Site Blumenau Brazil 89010-340
    26 Research Site Fortaleza Brazil 60336-045
    27 Research Site Ibirapuera Brazil 04501-000
    28 Research Site São José do Rio Preto Brazil 15090-000
    29 Research Site Vitoria Brazil 29043-260
    30 Research Site Panagyurishte Bulgaria 4500
    31 Research Site Sofia Bulgaria 1113
    32 Research Site Sofia Bulgaria 1618
    33 Research Site Victoria British Columbia Canada V8R 6V5
    34 Research Site Saint John New Brunswick Canada E2L 4L2
    35 Research Site Kingston Ontario Canada K7L 2V7
    36 Research Site Toronto Ontario Canada M5G 2M9
    37 Research Site Montreal Quebec Canada H4A 3J1
    38 Research Site Olomouc Czechia 77900
    39 Research Site Ostrava Czechia 703 00
    40 Research Site Praha 2 Czechia 128 08
    41 Research Site Praha Czechia 140 59
    42 Research Site Copenhagen Denmark 2100
    43 Research Site Odense C Denmark 5000
    44 Research Site Bordeaux France 33000
    45 Research Site Marseille France 13915
    46 Research Site Saint Herblain France 44805
    47 Research Site Strasbourg Cedex France 67091
    48 Research Site Toulouse France 31000
    49 Research Site Villejuif Cedex France 94805
    50 Research Site Esslingen Germany 73730
    51 Research Site Gauting Germany 82131
    52 Research Site Regensburg Germany 93049
    53 Research Site Athens Greece 11526
    54 Research Site Athens Greece 11527
    55 Research Site Heraklion Greece 711 11
    56 Research Site Holargos, Athens Greece 155 62
    57 Research Site Thessaloniki Greece 54645
    58 Research Site Hong Kong Hong Kong
    59 Research Site Budapest Hungary 1121
    60 Research Site Gyöngyös - Mátraháza Hungary 3200
    61 Research Site Győr Hungary 9024
    62 Research Site Szolnok Hungary 5004
    63 Research Site Törökbálint Hungary 2045
    64 Research Site Bengaluru India 560099
    65 Research Site Mohali India 160055
    66 Research Site New Dehli India 110029
    67 Research Site Haifa Israel 3109601
    68 Research Site Kfar Saba Israel 95847
    69 Research Site Petah Tikva Israel 49100
    70 Research Site Ramat Gan Israel 5265601
    71 Research Site Meldola Italy 47014
    72 Research Site Monza Italy 20900
    73 Research Site Orbassano Italy 10043
    74 Research Site Roma Italy 00144
    75 Research Site Rozzano Italy 20089
    76 Research Site Akashi-shi Japan 673-8558
    77 Research Site Bunkyo-ku Japan 113-8677
    78 Research Site Hiroshima-shi Japan 734-8551
    79 Research Site Kashiwa Japan 277-8577
    80 Research Site Koto-ku Japan 135-8550
    81 Research Site Nagoya-shi Japan 464-8681
    82 Research Site Nagoya-shi Japan 466-8560
    83 Research Site Osaka-shi Japan 534-0021
    84 Research Site Osaka-shi Japan 541-8567
    85 Research Site Sakai-shi Japan 591-8555
    86 Research Site Sendai-shi Japan 980-0873
    87 Research Site Sunto-gun Japan 411-8777
    88 Research Site Yokohama-shi Japan 241-8515
    89 Research Site Cheongju-si Korea, Republic of 28644
    90 Research Site Seoul Korea, Republic of 05505
    91 Research Site Seoul Korea, Republic of 06351
    92 Research Site Seoul Korea, Republic of 06591
    93 Research Site Suwon-si Korea, Republic of 16247
    94 Research Site Culiacan Mexico 80040
    95 Research Site Mexico Mexico 01710
    96 Research Site Breda Netherlands 4818 CK
    97 Research Site Maastricht Netherlands 6202 AZ
    98 Research Site Zwolle Netherlands 8025 AB
    99 Research Site Bellavista Peru CALLAO 2
    100 Research Site Lima Peru L41
    101 Research Site Lima Peru Lima 32
    102 Research Site Lima Peru LIMA 41
    103 Research Site Trujillo Peru
    104 Research Site Bydgoszcz Poland 85-796
    105 Research Site Gdańsk Poland 80-214
    106 Research Site Tomaszów Mazowiecki Poland 97-200
    107 Research Site Warszawa Poland 02-781
    108 Research Site Wrocław Poland 53-413
    109 Research Site Floresti Romania 407280
    110 Research Site Kazan Russian Federation 420029
    111 Research Site Krasnodar Russian Federation 350086
    112 Research Site Krasnoyarsk Russian Federation 660133
    113 Research Site Moscow Russian Federation 105229
    114 Research Site Moscow Russian Federation 115478
    115 Research Site Novosibirsk Russian Federation 630108
    116 Research Site Saint Petersburg Russian Federation 191036
    117 Research Site Saint Petersburg Russian Federation 197758
    118 Research Site Saint-Petersburg Russian Federation 197758
    119 Research Site Singapore Singapore 169610
    120 Research Site Barcelona Spain 08041
    121 Research Site Madrid Spain 28041
    122 Research Site Málaga Spain 29010
    123 Research Site Oviedo Spain 33011
    124 Research Site Pamplona Spain 31008
    125 Research Site Santiago De Compostela (A Coruña) Spain 15706
    126 Research Site Stockholm Sweden 17176
    127 Research Site Lausanne Switzerland 1011
    128 Research Site Zürich Switzerland CH-8091
    129 Research Site Chiayi Taiwan 613
    130 Research Site Taichung Taiwan 40201
    131 Research Site Taipei 112 Taiwan
    132 Research Site Taipei City Taiwan 114
    133 Research Site Taipei Taiwan 10002
    134 Research Site Taipei Taiwan 10449
    135 Research Site Taipei Taiwan 235
    136 Research Site Tao-Yuan Taiwan
    137 Research Site Bangkok Thailand 10300
    138 Research Site Bangkok Thailand 10330
    139 Research Site Chiang Mai Thailand 50200
    140 Research Site Khon Kaen Thailand 40002
    141 Research Site Phisanulok Thailand 65000
    142 Research Site Adana Turkey 01120
    143 Research Site Ankara Turkey 06010
    144 Research Site Istanbul Turkey 34010
    145 Research Site Istanbul Turkey 34214
    146 Research Site Malatya Turkey 44100
    147 Research Site Hanoi Vietnam 100000
    148 Research Site Ho Chi Minh Vietnam 70000

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Solange Peters, Centre Hospitalier Universitaire Vaudois (CHUV)
    • 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:
    NCT04385368
    Other Study ID Numbers:
    • D910LC00001
    First Posted:
    May 12, 2020
    Last Update Posted:
    Aug 2, 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
    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:
    Carcinoma, Non-Small-Cell Lung
    Durvalumab

    Study Results

    No Results Posted as of Aug 2, 2022