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Clinical Trials List

Protocol NumberD910MC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04642469

2020-08-21 - 2024-03-26

Phase III

Recruiting7

ICD-10C46.50

Kaposi's sarcoma of unspecified lung

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 (MERMAID-2)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

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 Recruiting

Principal Investigator Po-Hao Feng 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 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 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC

Objectives

Primary: To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set Secondary: To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set and in all randomized patients To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC≥1% analysis set and in all randomized patients To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo To investigate the relationship between a patient’s baseline PD-L1 TC expression and efficacy of study treatments

Test Drug

Durvalumab

Active Ingredient

Durvalumab

Dosage Form

Injection

Dosage

50mg/ml

Endpoints

Primary:
DFS in PD-L1 TC≥1% (using Investigator
assessments according to RECIST 1.1)

Secondary:
DFS in FAS (using Investigator assessments
according to RECIST 1.1)
DFS (using BICR assessments according to RECIST
1.1) in PD-L1 TC≥1% and in FAS
PFS (using local standard practice)
Time to first subsequent therapy (TFST)
Time to second subsequent therapy (TSST)
OS in PD-L1 TC≥1% and in FAS
Change from baseline and time to deterioration in
EORTC QLQ-C30 and EORTC QLQ-LC13
IHC analysis of PD-L1 TC expression and spatial
distribution within the tumor microenvironment
relative to efficacy outcomes (ie, DFS, OS)

Inclution Criteria

1. Capable of giving signed informed consent which includes compliance with the require-ments and restrictions listed in the ICFs and in this protocol.
2. Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses.
- ICF1 must be signed and dated prior to initiation of the first screening and surveillance activities.
- ICF2a must be signed and dated prior to initiation of the second screening activities and randomization.
- ICF2b must be signed and dated prior to initiation of the study-specific observation period and procedures.
3. Provision of signed and dated written optional genetic informed consent prior to collection of the optional sample for genetic analysis. This consent should be signed at the time of second screening. This optional sample and analyses are separate from the mandatory ge-netic testing consent included in ICF1.

Inclusion criteria assessed during the first screening period
The following criteria must have been met at the time of surgery or at the time of the cu-rative intent therapy (first screening):
Age
4. Age >= 18 years at the time of screening (ICF1).
Sex
5. Male and/or female.
Type of subject and disease characteristics
6. Histologically confirmed NSCLC with resectable stage II-III disease (according to IASLC Staging Manual in Thoracic Oncology v8.0) who have undergone curative intent therapy (complete resection of the primary tumor ± neoadjuvant and/or adjuvant therapy) per SoC.
Select stage IIIB (ie, T3N2 or T4N2) patients will be eligible, provided they are upstaged to T3N2 or T4N2 based on confirmed pathology after surgery. Patients who are staged as T3N2 or T4N2 prior to surgery are not eligible.
7. A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and adrenal glands) along with brain MRI (preferred) or brain CT with IV contrast must have been done for surgical planning prior to surgery. It is recommended that patients undergo com-bined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan (computerized tomography) within the 6 weeks prior to surgery in order to rule out detect-able extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. If the positron emission tomography (PET) scan was not performed, or data from a PET is not available, patients may still be enrolled into the study provided appropriate imaging (CT/MRI) is performed prior to randomization.
8. Complete resection of the primary NSCLC is mandatory. Invasive (pre-operative or intra-operative) exploration of hilar and mediastinal lymph nodes must have been performed to confirm primary tumor nodal status (prior to or after surgery). 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, bi-lobectomy or pneumonectomy. Patients undergoing wedge resection are not eligible for this study.
- Note: Where a resection has been extended by means of a wedge resection of an adja-cent 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.
- Note: Carcinoma-in-situ can be present at the bronchial margin.

Criteria for prior systemic chemotherapy/radiotherapy:
9. Patients should have completed (or be undergoing) curative intent therapy (surgery ± neo-adjuvant and/or adjuvant therapy; adjuvant therapy can include PORT) with exceptions noted below:
- Patients who discontinue chemotherapy and/or PORT for toxicity prior to completion of all planned therapy are eligible.
- Patients who have not received any neoadjuvant and/or adjuvant chemotherapy, and meet all other eligibility criteria, may be eligible under the following circumstances:
(1) All patients who are eligible for adjuvant chemotherapy MUST be offered adju-vant chemotherapy.
(2) The patient has declined adjuvant chemotherapy, and in the opinion of the Investi-gator, this is the patient’s final decision after receiving appropriate information and adequate time to make the decision. The patient’s refusal of adjuvant chemo-therapy must be documented.
(3) If in the view of the Investigator, adjuvant chemotherapy is contraindicated due to an underlying intercurrent illness/laboratory abnormality, which is not considered reversible within a reasonable timeframe for the patient to be eligible for adjuvant therapy, which must be documented.

Criteria assessed prior to and at the start of surveillance:
10. Confirmation of suitable biosamples for WES and central PD-L1 testing. Resected tumor tissue and whole blood samples must be provided to the diagnostic laboratory for WES of tumor and germline DNA, respectively as soon as possible following pathology confirma-tion. Samples must be sent no later than 1-2 weeks after completion of adjuvant therapy or 3-5 weeks after surgery (if no adjuvant therapy is given) for development of the Sponsor-approved personalized panel for MRD detection at a central reference laboratory. Germline sequencing of whole blood is mandatory. Resected tumor tissue must also be provided for PD-L1 testing at a central reference laboratory (see inclusion criteria 15).
11. Post-adjuvant therapy or post-surgery (if no adjuvant therapy is given) CT scan of the chest and abdomen (including liver and adrenal glands) and brain MRI [preferred] or brain CT with IV contrast should be available to confirm no evidence of metastasis. If scans were not performed post-curative intent therapy, additional scans must be done prior to start of surveillance.
12. Consents to be accessible for q6w +/- 3d plasma sample collection for MRD evaluation and for q12w +/- 1w CT scans during the 96-week surveillance period.
13. The plasma sample that marks the start of surveillance must be collected 8 +/- 1 weeks after completion of adjuvant therapy (if administered) or 12 +/- 1 weeks after surgery (where adjuvant therapy is not given).
- A patient who is determined to be MRD- based on analysis of this plasma sample (ie, MRD- at the start of surveillance) may continue in surveillance provided all other eli-gibility criteria are met.
- A patient who is determined to be MRD+ based on analysis of this plasma sample (ie, MRD+ at the start of surveillance) may be eligible for immediate randomization pro-vided all other eligibility criteria are met.
o Note: In order for a patient who received prior neoadjuvant IO immunother-apy to continue in the study, they must be MRD- based on analysis of this plasma sample (ie, must be MRD- at the start of surveillance).
- A patient who becomes MRD+ during surveillance is eligible to enter the second screening period and may be randomized in the study if all other eligibility criteria are met.

Inclusion criteria assessed during the second screening period
Criteria for second screening prior to randomization to treatment:
14. CT scan of the chest and abdomen (including liver and adrenal glands) and brain MRI [pre-ferred] or brain CT with IV contrast performed within the 28 days +/- 7 days prior to ran-domization to confirm no evidence of RECIST 1.1-defined disease recurrence and/or me-tastasis.
15. Known tumor PD-L1 status determined at a central reference laboratory testing service us-ing a validated Ventana SP263 PD-L1 immunohistochemistry (IHC) assay prior randomiza-tion. Patients with unknown PD-L1 status are not eligible for the study.
16. WHO/Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
17. Complete post-operative wound healing must have occurred prior to randomization; pa-tients must have recovered from all acute, reversible toxic effects from prior treatments (excluding alopecia) that could potentially adversely impact further administration of dur-valumab/placebo according to the Investigator’s judgment.
18. Must have recovered from all acute, reversible toxic effects from chemotherapy that could potentially adversely impact further administration of durvalumab or placebo according to the Investigator’s judgment
19. 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 pa-tients with confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN
- Measured creatinine clearance (CL) >= 30 mL/min or Calculated CL >30 mL/min as determined by Cockcroft-Gault (using actual body weight)

Males:
Creatinine CL(mL/min) = [Weight (kg) × (140 - Age)] / [72 × serum creatinine (mg/dL)]
Females:
Creatinine CL(mL/min) = [Weight (kg) × (140 - Age) × 0.85] / [72 × serum creatinine (mg/dL)]

20. Must have a life expectancy of at least 12 weeks
Weight
21. Body weight >30 kg

Inclusion criteria assessed prior to entering the observation period
22. No evidence of RECIST 1.1-defined disease recurrence or metastasis confirmed by CT scan of the chest and abdomen (including liver and adrenal glands) and a brain MRI (pre-ferred) or brain CT with IV contrast.
23. MRD- status, as determined by testing the last plasma sample collected during the 96-week surveillance period.

Exclusion Criteria

1 EGFR and/or ALK mutant as assessed either from the tumor biopsy taken prior to surgery or the resected tumor tissue. Testing must be performed using a well-validated, local regu-latory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable.
2 Mixed small cell and NSCLC histology.
3 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 sig-nificant part of their practice.
4 Baseline imaging demonstrating unequivocal evidence of RECIST 1.1-defined disease re-currence or evidence of clinical recurrence outside of imaging prior to randomization. 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.
Medical conditions
5 History of allogeneic organ or bone marrow transplantation.
6 Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection
7 Active or prior documented autoimmune or inflammatory disorders (including inflammato-ry bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diver-ticulosis], 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 con-sultation with the Study Physician
- Patients with celiac disease controlled by diet alone
8 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 as-sociated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
9 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
10 History of active primary immunodeficiency
11 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 virus (HBV) (known positive HBV surface antigen (HBsAg) result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibod-ies). 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.
12 Known allergy or hypersensitivity to any of the IPs or any of the IP excipients
Prior/concomitant therapy
13 Received any IO therapy in the adjuvant setting or any prior exposure to durvalumab.
14 Received any radiotherapy in the neoadjuvant setting.
15 Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone re-placement therapy) is acceptable.
16 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.
17 Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Pa-tients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
18 Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
19 Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injec-tion)
- 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
20 Previous IP assignment in the present study
21 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
22 Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
Other exclusions
23 Female patients who are pregnant or breastfeeding.
− Female patients who become pregnant during the study will be withdrawn from sur-veillance and are not eligible for randomization.
24 Male or female patients of reproductive potential who are not willing to employ effective birth control at the time of entry into second screening (initiated with the signing of ICF2a) until 90 days after the last dose of IP.
25 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 require-ments.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    1500 participants

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