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Clinical Trials List

Protocol NumberD910LC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04385368
Completed

2020-05-12 - 2025-12-31

Phase III

Not yet recruiting6

Recruiting2

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

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)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 楊聰明 Division of Thoracic Medicine
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Completely Resected Stage II-III NSCLC

Objectives

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 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.

Test Drug

Durvalumab
Durvalumab

Active Ingredient

Durvalumab
Durvalumab

Dosage Form

injection
injection

Dosage

50mg/ml
50mg/ml

Endpoints

Primary Outcome Measures :
Disease free survival (DFS) in MRD+ analysis set (using Investigator assessments according to RECIST 1.1) [ Time Frame: approximately 4 years ]
To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients

Inclution Criteria

1 ICF1 must be signed and dated prior to any study procedures and prior to the planned
surgical resection of the primary NSCLC, with the exception noted below. This consent
will cover the study-specific procedures, sampling, and analyses outlined in Table 1.
 Exception: Patients will be permitted to sign ICF1 after surgery. In this case, a
post-surgical whole blood sample and resected tumor tissue must be collected as soon
as possible for development of the personalized panel. The plasma sample to
determine MRD status must still be collected between Weeks 3 and 4 post-surgery,
even if creation of the personalized panel for MRD detection is delayed. Only
patients identified as MRD+ based on the post-surgery plasma sample may be
randomized in the study, provided all additional inclusion and none of the exclusion
criteria are met.
 Patients randomized to the MRD- cohort must have had a plasma sample collected
prior to surgery and will not be eligible for the study if they signed ICF1 after surgery.
Patients will not be excluded from randomization based on the results of the presurgical sample. Please refer to inclusion criterion 7 (below).
Age
2 Age ≥18 years at the time of screening.
Sex
3 Male and/or female.
4 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 as
T3N2 or T4N2 prior to surgery are not eligible.
5 A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and adrenal
glands) 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 in order to rule out detectable extrathoracic, extracranial
metastasis and to assess for potential mediastinal lymph node involvement prior to
surgery. 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]). Brain MRI (preferred) or brain CT with
IV contrast is required for complete staging of the tumor. Imaging should occur within
6 weeks prior to surgery.
6 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:
(a) The surgeon performing the resection should remove all gross disease by the end of
surgery. All surgical margins of resection must be negative for tumor.
(b) 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).
(c) 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.
7 Collection of a pre-surgical plasma sample for MRD evaluation is preferred for all
patients but is mandatory in order for any MRD- patient to be randomized. (Note: MRDpatients will not be excluded from randomization based on the results of this pre-surgery
plasma assessment).
8 Confirmation of suitable resected tumor tissue and whole blood sample for WES of tumor
and germline DNA, respectively, and creation of Sponsor-approved personalized panel
for MRD determination. Tumor tissue and whole blood samples must be provided to the
diagnostic laboratory for development of the personalized panel as soon as possible
following pathology confirmation. Germline sequencing of whole blood is mandatory.
9 Established MRD status (+/-) based on Sponsor-approved personalized assay of a plasma
sample collected between Weeks 3 and 4 post-surgery.
10 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.
11 Post-operative CT scan of the chest and abdomen (including liver and adrenal glands)
performed within 28 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.
12 ICF2 must be signed and dated after MRD status is determined; within the 12 weeks
(±7 days) following surgery; and prior to initiation of any study-specific procedures,
sampling, and analyses outlined in SoAs in Table 2 and Table 3.
13 WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
14 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.
15 Eligible to tolerate 4 cycles of platinum-based adjuvant chemotherapy
16 Adequate organ and marrow function as defined below:
 Hemoglobin ≥9.0 g/dL
 Absolute neutrophil count ≥1.5 × 109
/L
 Platelet count ≥100 × 109
/L
 Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to
patients with confirmed Gilbert’s syndrome, who will be allowed in consultation with
their physician.
 ALT and AST ≤2.5 × ULN
 Measured creatinine clearance (CL) ≥40 mL/min or Calculated creatinine CL
>40 mL/min as determined by Cockcroft-Gault (using actual body weight)
17 Must have a life expectancy of at least 12 weeks
18 Body weight >30 kg

Exclusion Criteria

1 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.
2 EGFR-mutant and/or ALK-translocation as assessed either from the tumor biopsy taken
prior to surgery (preferred) or the resected tumor tissue (if biopsy was not evaluable). If a
pre-surgery biopsy is not available, testing will be conducted as soon as possible
post-surgery on the resected tumor tissue while the personalized panel is in development;
patients will still be allowed to continue with study procedures while testing is ongoing
but will be excluded from randomization if their resected tumor tissue tests positive for
EGFR mutations and/or ALK translocations. Testing must be performed using a
well-validated, local regulatory approved test. EGFR/ALK may be tested centrally if local
testing is unavailable.
3 Mixed small cell and NSCLC histology.
4 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.
5 Patients who are candidates to undergo only wedge resections.
6 History of allogeneic organ or bone marrow transplantation.
7 Non-leukocyte-depleted whole blood transfusion within 120 days of genetic sample
collection.
8 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
9 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.
10 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
11 History of active primary immunodeficiency
12 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.
13 Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
14 Any medical contraindication to treatment with platinum-based doublet chemotherapy as
listed in the local labeling.
15 Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab.
16 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.
17 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.
18 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.
19 Major surgical procedure (as defined by the Investigator) within 28 days prior to the first
dose of IP.
20 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)
21 Participation in another clinical study with an IP administered since completion of
surgery.
22 Previous IP assignment in the present study.
23 Concurrent enrollment in another clinical study, unless it is an observational
(non-interventional) clinical study, or during the follow-up period of an interventional
study.
24 Prior randomization or treatment in a previous durvalumab clinical study regardless of
treatment group assignment.
25 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.
26 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.

The Estimated Number of Participants

  • Taiwan

    32 participants

  • Global

    332 participants

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