AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3MERMAID-1NCT04385368

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)

A Phase 3 study testing Durvalumab + SoC chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 140 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Durvalumab + SoC chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
140 sitesin 33 countries
Study dates
17 Jul 2020to 31 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be 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 in this protocol. Provision of signed and dated, written ICFs must occur prior to any mandatory study-specific procedures, sampling, and analyses.
  • In addition to ICF1 and ICF2, patients will provide signed and dated written optional genetic informed consent prior to collection of a sample for optional genetic analysis at the time of second screening (Table 2). This is different from the genetic samples and testing covered by ICF1, which are mandatory for participation in this study.
  • Criteria and procedures initiated with the signing of ICF1
  • ICF1 must be signed and dated prior to any study procedures and prior to the planned surgical resection of the primary NSCLC, with the exceptions noted below. This consent will cover the study-specific first screening procedures outlined in Table 1.
  • Exception: Patients will be permitted to sign ICF1 up to Week 3 (Day 21) postsurgery. Patients identified after Week 3 post-surgery but prior to Week 5 (Day 35) post-surgery may be allowed to sign ICF1 depending on the outcome of the discussion with the study physician. In these cases, a whole blood sample and resected tumor tissue must be collected and sent to the diagnostic lab as soon as possible after ICF1 is signed for development of the personalized panel. A plasma sample must still be collected at Week 3-5 (Day 21-35) post-surgery, even if creation of the personalized panel for MRD detection is delayed.
  • Age
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  • Age ≥18 years at the time of screening. Sex
  • Male and/or female. Type of patient and disease characteristics
  • Individuals who have diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease (according to IASLC Staging Manual in Thoracic Oncology v8.0). Select (ie, T3N2 or T4N2) stage IIIB patients will be eligible, provided that they are upstaged to T3N2 or T4N2 based on confirmed pathology. Patients who are staged asT3N2 or T4N2 prior to surgery are not eligible.
  • A contrast-enhanced CT or MRI scan of the chest must have been done for surgical planning prior to surgery. It is recommended that patients undergo combined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan (contrastenhanced or low-dose CT component) in order to rule out detectable extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. In the absence of pre-operative FDG-PET CT imaging, pre-operative contrast-enhanced CT imaging or MRI scan must cover liver and adrenal glands. If only CT is available, or FDG-PET reveals suspicious lymph node mediastinal involvement, it is recommended that invasive pre-operative mediastinal staging is performed according to the algorithm of the European Society of Thoracic Surgeons guidelines (algorithm to follow for primary mediastinal staging if only pre-operative CT is available [De Leyn et al 2007], algorithm to follow for primary mediastinal staging when PET-CT is available [De Leyn et al 2014]). It is preferred that imaging occurs within 6 weeks prior to surgery. Brain MRI (preferred) or brain CT with IV contrast is required for complete staging of the tumor.
  • Complete resection of the primary NSCLC is mandatory. The primary tumor must be deemed resectable by a multidisciplinary evaluation that must include a thoracic surgeon certified or trained according to local standards and who performs lung cancer surgery as a significant part of their practice. Surgical resection of the primary NSCLC can occur by open thoracotomy or by video-assisted thoracic surgery (VATS) and resection can be achieved by segmentectomy, lobectomy, sleeve resection, bilobectomy, or pneumonectomy. Patients undergoing wedge resection are not eligible for this study. Note: Patients undergoing segmentectomy must have tumors less than 2 cm in maximum diameter. Where a resection has been extended by means of a wedge resection of an adjacent lobe to ensure complete resection of a tumor at or crossing a fissure between lobes, this is acceptable if surgical margins are clear of disease. Where the resection of a second tumor nodule (eg, a T4 lesion) is undertaken by means of a wedge resection of a separate lobe, then the patient is not eligible.
  • At a minimum, the following parameters should be met for a tumor to be declared completely resected:
  • The surgeon performing the resection should remove all gross disease by the end of surgery. All surgical margins of resection must be macroscopically negative for tumor.
  • Pathology and/or operative reports must include the examination of at least 2 different mediastinal lymph node (N2) levels, one of which is the subcarinal node-group (level 7) and the second of which is lobe-specific (defined below).
  • Note: In the uncommon clinical situation where the surgeon thoroughly examines a mediastinal lymph node level and does not find any lymph nodes, that mediastinal lymph node level may be counted among the minimum 2 required levels. However, the surgeon must clearly document in the operative report or in a separate written statement that the lymph node level was explored and no lymph nodes were present. Normal appearing lymph nodes, if present, must be biopsied or removed. Exploration of nodes must clearly be documented in medical file if not recorded in operative report.
  • Note: Lobe-specific lymph node stations are classified based on the location of the primary tumor as follows (based on IASLC 2009 lymph node map terminology [Rusch et al 2009]): Stations 2R and 4R for right upper lobe or middle lobe tumors, stations 4L, 5, and 6 for left upper lobe tumors, stations 8 and 9 for lower lobe tumors of both sides (Adachi et al 2017, Rami-Porta et al 2005).
  • No extracapsular nodal extension of the tumor is observed in resected mediastinal N2 lymph nodes.
  • Note: Extracapsular nodal extension in resected N1 nodes is permitted. Note: The highest mediastinal node resected can be positive for malignancy. Note: Carcinoma-in-situ can be present at the bronchial margin.
  • All patients who enrol in the study prior to surgery must have a pre-surgical plasma sample collected for MRD evaluation. Patients will not be excluded from randomization based on the results of analysing the pre-surgical plasma samples.
  • The following criteria must be met prior to signing ICF2:
  • Confirmation of suitable samples of resected tumor tissue and whole blood for WES of tumor and germline DNA, respectively, and creation of Sponsor-approved personalized panel for MRD detection. Tumor tissue and whole blood samples must be provided to the diagnostic laboratory for development of the personalized panel as soon as possible.
  • Germline sequencing of whole blood is mandatory. Note: If a patient's tumor has less than the requisite 50 tumor-specific variants, a panel cannot be built and the patient will no longer be able to participate in the study.
  • Established MRD status (MRD+ or MRD-) based on Sponsor-approved personalized assay of a plasma sample collected at Week 3-5 (Day 21-35) post-surgery.
  • Known tumor PD-L1 status determined at a central reference laboratory testing service using a validated Ventana SP263 PD-L1 immunohistochemistry (IHC) assay prior randomization. Patients with unknown PD-L1 status are not eligible for the study.
  • Criteria and procedures initiated with the signing of ICF2
  • Post-operative CT scan of the chest (including liver and adrenal glands) performed within 28 days + 7 days prior to randomization. If clinically indicated, additional scans (such as brain MRI [preferred] or brain CT with IV contrast) should be performed to confirm no evidence of metastasis.
  • ICF2 must be signed and dated after MRD status is determined and prior to initiation of any study-specific procedures, sampling, and analyses outlined in SoAs in Table 2 and Table 3. Randomization must occur within the 12 weeks (+ 7 days) following surgery.
  • WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Complete postoperative wound healing must have occurred prior to randomization; patients must have recovered from all acute, reversible toxic effects from prior treatments (excluding alopecia) that could potentially adversely impact further administration of durvalumab/placebo or chemotherapy according to the Investigator's judgment.
  • Eligible to tolerate 4 cycles of platinum-based adjuvant chemotherapy
  • Adequate organ and marrow function as described in the protocol. 17 Must have a life expectancy of at least 12 weeks Weight 18 Body weight >30 kg

Who cannot join

  • Diagnostic assessments
  • Post-operative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph-node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded.
  • EGFR-mutant and/or ALK-translocation-positive, as assessed either from a pre-surgical biopsy sample (preferred) or the resected tumor tissue (if biopsy was not evaluable or available). Any of the following scenarios are acceptable for this study:
  • Where EGFR/ALK results are obtained from a pre-surgical tissue biopsy as part of standard local practice, the patient must be confirmed EGFR/ALK wild-type prior to enrolling in the study.
  • Results obtained from testing the patient's primary tumor tissue during screening for another AstraZeneca study may be used in this study.
  • Results from local testing of a pre-surgical biopsy. All local EGFR/ALK testing performed locally must be performed using a well-validated, local regulatory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable. Patients will still be allowed to continue with first screening procedures while testing is ongoing but will not be able to continue into second screening if their tumor tests positive for EGFR mutations and/or ALK translocations.
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  • Mixed small cell and NSCLC histology.
  • Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice.
  • Patients who are candidates to undergo only wedge resections. Medical conditions
  • History of allogeneic organ or bone marrow transplantation.
  • Non-leukocyte-depleted whole blood transfusion within 120 days of genetic sample collection. Note: This exclusion criterion only relates to whole blood and does not include other blood products (eg, packed red blood cells).
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
  • Patients with celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
  • History of another primary malignancy, except for
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma-in-situ without evidence of disease
  • History of active primary immunodeficiency
  • Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (HBV; known positive HBV surface antigen [HBsAg] result), hepatitis C (HCV), or human immunodeficiency virus infection (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
  • Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labeling.
  • Prior/concomitant therapy
  • Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab.
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
  • Radiotherapy treatment for NSCLC in the neoadjuvant setting. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab/placebo. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) Prior/concurrent clinical study experience
  • Participation in another clinical study with an IP administered since completion of surgery.
  • Previous IP assignment in the present study.
  • Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study, or during the follow-up period of an interventional study.
  • Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment group assignment.
  • Other exclusions
  • Patients who are never-smokers; defined as no more than 100 cigarettes or its equivalent in his/her lifetime.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab/placebo.
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

Trial locations and contacts

140 sites in 33 countries.

140 sites in 33 countries

United States15 sites

  • Research Site

    Albuquerque, New Mexico, 87131

  • Research Site

    Birmingham, Alabama, 35294

  • Research Site

    Durham, North Carolina, 27710

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Lincoln, Nebraska, 68510

  • Research Site

    Long Beach, California, 90806

  • Research Site

    Miami, Florida, 33136

  • Research Site

    Minneapolis, Minnesota, 55407

  • Research Site

    New York, New York, 10032

  • Research Site

    Santa Rosa, California, 95403

  • Research Site

    Seattle, Washington, 98108-1532

  • Research Site

    Silver Spring, Maryland, 20910

  • Research Site

    Sioux Falls, South Dakota, 57105

  • Research Site

    Spartanburg, South Carolina, 29303

  • Research Site

    West Hollywood, California, 90048

Other trials in United States

Japan12 sites

  • Research Site

    Akashi-shi, 673-8558

  • Research Site

    Bunkyō City, 113-8677

  • Research Site

    Hiroshima, 734-8551

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Nagoya, 466-8560

  • Research Site

    Osaka, 534-0021

  • Research Site

    Osaka, 541-8567

  • Research Site

    Sendai, 980-0873

  • Research Site

    Sunto-gun, 411-8777

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

Russia8 sites

  • Research Site

    Kazan', 420029

  • Research Site

    Krasnodar, 350086

  • Research Site

    Krasnoyarsk, 660133

  • Research Site

    Moscow, 105229

  • Research Site

    Moscow, 115478

  • Research Site

    Novosibirsk, 630108

  • Research Site

    Saint Petersburg, 191036

  • Research Site

    Saint Petersburg, 197758

Other trials in Russia

Taiwan8 sites

  • Research Site

    Chiayi City, 613

  • Research Site

    Taichung, 40201

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 10449

  • Research Site

    Taipei, 114

  • Research Site

    Taipei, 235

  • Research Site

    Taipei

  • Research Site

    Taoyuan

Other trials in Taiwan

Brazil6 sites

  • Research Site

    Belo Horizonte, 30110-022

  • Research Site

    Blumenau, 89010-340

  • Research Site

    Fortaleza, 60336-045

  • Research Site

    São José do Rio Preto, 15090-000

  • Research Site

    São Paulo, 04501-000

  • Research Site

    Vitória, 29043-260

Other trials in Brazil

France6 sites

  • Research Site

    Bordeaux, 33000

  • Research Site

    Marseille, 13915

  • Research Site

    Saint-Herblain, 44805

  • Research Site

    Strasbourg, 67091

  • Research Site

    Toulouse, 31000

  • Research Site

    Villejuif, 94805

Other trials in France

Spain6 sites

  • Research Site

    Barcelona, 08041

  • Research Site

    Madrid, 28041

  • Research Site

    Málaga, 29010

  • Research Site

    Oviedo, 33011

  • Research Site

    Pamplona, 31008

  • Research Site

    Santiago de Compostela (A Coruña), 15706

Other trials in Spain

Belgium5 sites

  • Research Site

    Aalst, 9300

  • Research Site

    Brussels, 1200

  • Research Site

    Hasselt, 3500

  • Research Site

    Leuven, 3000

  • Research Site

    Roeselare, 8800

Other trials in Belgium

Canada5 sites

  • Research Site

    Kingston, Ontario, K7L 2V7

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Saint John, New Brunswick, E2L 4L2

  • Research Site

    Toronto, Ontario, M5G 2M9

  • Research Site

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Greece5 sites

  • Research Site

    Athens, 11526

  • Research Site

    Athens, 11527

  • Research Site

    Heraklion, 711 11

  • Research Site

    Holargos, Athens, 155 62

  • Research Site

    Thessaloniki, 54645

Other trials in Greece

Hungary5 sites

  • Research Site

    Budapest, 1121

  • Research Site

    Gyöngyös - Mátraháza, 3200

  • Research Site

    Győr, 9024

  • Research Site

    Szolnok, 5004

  • Research Site

    Törökbálint, 2045

Other trials in Hungary

Poland5 sites

  • Research Site

    Bydgoszcz, 85-796

  • Research Site

    Gdansk, 80-214

  • Research Site

    Tomaszów Mazowiecki, 97-200

  • Research Site

    Warsaw, 02-781

  • Research Site

    Wroclaw, 53-413

Other trials in Poland

South Korea5 sites

  • Research Site

    Cheongju-si, 28644

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 06591

  • Research Site

    Suwon, 442-723

Other trials in South Korea

Thailand5 sites

  • Research Site

    Bangkok, 10300

  • Research Site

    Bangkok, 10330

  • Research Site

    Chiang Mai, 50200

  • Research Site

    Khon Kaen, 40002

  • Research Site

    Phisanulok, 65000

Other trials in Thailand

Turkey (Türkiye)5 sites

  • Research Site

    Adana, 01120

  • Research Site

    Ankara, 06010

  • Research Site

    Istanbul, 34010

  • Research Site

    Istanbul, 34214

  • Research Site

    Malatya, 44100

Other trials in Turkey (Türkiye)

Czechia4 sites

  • Research Site

    Olomouc, 77900

  • Research Site

    Ostrava, 703 00

  • Research Site

    Prague, 128 08

  • Research Site

    Prague, 140 59

Other trials in Czechia

Israel4 sites

  • Research Site

    Haifa, 3109601

  • Research Site

    Kfar Saba, 95847

  • Research Site

    Petah Tikva, 49100

  • Research Site

    Ramat Gan, 5265601

Other trials in Israel

Bulgaria3 sites

  • Research Site

    Panagyurishte, 4500

  • Research Site

    Sofia, 1113

  • Research Site

    Sofia, 1618

Other trials in Bulgaria

Germany3 sites

  • Research Site

    Esslingen am Neckar, 73730

  • Research Site

    Gauting, 82131

  • Research Site

    Regensburg, 93049

Other trials in Germany

India3 sites

  • Research Site

    Bengaluru, 560099

  • Research Site

    Delhi, 110029

  • Research Site

    Mohali, 160055

Other trials in India

Italy3 sites

  • Research Site

    Meldola, 47014

  • Research Site

    Orbassano, 10043

  • Research Site

    Roma, 00144

Other trials in Italy

Netherlands3 sites

  • Research Site

    Breda, 4818 CK

  • Research Site

    Maastricht, 6202 AZ

  • Research Site

    Zwolle, 8025 AB

Other trials in Netherlands

Australia2 sites

  • Research Site

    Camperdown, 2050

  • Research Site

    St Leonards, 2065

Other trials in Australia

Denmark2 sites

  • Research Site

    Copenhagen, 2100

  • Research Site

    Odense C, 5000

Other trials in Denmark

Mexico2 sites

  • Research Site

    Culiacán, 80040

  • Research Site

    México, 01710

Other trials in Mexico

Switzerland2 sites

  • Research Site

    Lausanne, 1011

  • Research Site

    Zurich, CH-8091

Other trials in Switzerland

Vietnam2 sites

  • Research Site

    Hanoi, 100000

  • Research Site

    Ho Chi Minh City, 70000

Other trials in Vietnam

Argentina1 site

  • Research Site

    Rosario, S2000CVB

Other trials in Argentina

Hong Kong1 site

  • Research Site

    Hong Kong

Other trials in Hong Kong

Peru1 site

  • Research Site

    Lima, Lima 32

Other trials in Peru

Romania1 site

  • Research Site

    Floreşti, 407280

Other trials in Romania

Singapore1 site

  • Research Site

    Singapore, 169610

Other trials in Singapore

Sweden1 site

  • Research Site

    Stockholm, 17176

Other trials in Sweden

About this study

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)

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

Read the 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 as measured by DFS in all patients.

Being tested
Durvalumab + SoC chemotherapy, Placebo + SoC chemotherapy
Keywords
NCSLC, Double-blind, PD-L1, MEDI4736, Durvalumab, DFS, OS, MRD+, MRD-, Completely Resected Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Durvalumab + SoC chemotherapyDrug

    Also called MEDI4736

    Experimental Treatment

  • Placebo + SoC chemotherapyOther

    Also called Placebo

    Placebo Comparator

Study groups in NCT04385368
Study groupRoleWhat they receive
Durvalumab + SoC chemotherapyExperimentalIntravenous administration of Experimental and Standard of Care Therapy
Receives: Drug: Durvalumab + SoC chemotherapy
Placebo + SoC chemotherapyPlacebo comparatorIntravenous administration of Placebo and Standard of Care Therapy
Receives: Other: Placebo + SoC chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival (DFS) in FAS (Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1])

    DFS was defined as the time from the date of randomization until either of the following events, whichever occurred first: disease recurrence using Investigator RECIST 1.1 assessments (i.e., local or regional recurrence, distant recurrence, second primary NSCLC) or death from any cause.

    Measured: Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months

Secondary outcomes (3)

  1. DFS in Minimal Residual Disease-positive (MRD+) Analysis Set (Using Investigator Assessments According to RECIST 1.1)

    DFS was defined as the time from the date of randomization until either of the following events, whichever occurred first: disease recurrence using Investigator RECIST 1.1 assessments (i.e., local or regional recurrence, distant recurrence, second primary NSCLC) or death from any cause.

    Measured: Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months

  2. OS in FAS

    OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.

    Measured: From the date of randomization until death due to any cause, up to 35 months

  3. Overall Survival (OS) in MRD+ Analysis Set

    OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.

    Measured: From the date of randomization until death due to any cause, up to 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start17 Jul 2020
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04385368
Sponsor's protocol ID
D910LC00001
Other IDs
2020-000556-35
Acronym
MERMAID-1
Status last verified
Aug 2024
First submitted
30 Apr 2020
Last updated
30 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab + SoC chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 140 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Japan, Russia, Taiwan, Brazil and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) in FAS (Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1]) (time frame: Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04385368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.

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