Phase III study to evaluate the efficacy and safety of durvalumab compared to placebo in patients with NSCLC who have minimal residual disease after surgery +/- additional therapy before or after surgery.

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) - MERMAID-2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000612-30-NL

Enrollment

284

Registered

2020-09-16

Start date

2021-02-24

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completely resected stage II-III NSCLC MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: durvalumab Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

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 regulatory approved test; 2.Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who perform lung cancer surgery as a significant part of their practice; 3.History of allogeneic organ or bone marrow transplantation; 4.Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection;

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of durvalumab compared to placebo as measured by DFS (using Investigator assessment according to RECIST 1.1.) in the PD-L1 TC=1% analysis set;Secondary Objective: 1.To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients (using investigator assessment according to RECIST 1.1); 2.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 (using BICR assessment according to RECIST 1.1); 3.To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes; 4.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; 5.To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo; 6.To investigate the relationship between a patient’s baseline PD-L1 TC expression and efficacy of study treatments;Primary end point(s): DFS in PD-L1 TC=1% (using Investigator assessments according to RECIST 1.1);Timepoint(s) of evaluation of this end point: Approximately 3 years	—

Measure

Time frame

Main Objective: To assess the efficacy of durvalumab compared to placebo as measured by DFS (using Investigator assessment according to RECIST 1.1.) in the PD-L1 TC=1% analysis set;Secondary Objective: 1.To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients (using investigator assessment according to RECIST 1.1); 2.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 (using BICR assessment according to RECIST 1.1); 3.To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes; 4.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; 5.To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo; 6.To investigate the relationship between a patient’s baseline PD-L1 TC expression and efficacy of study treatments;Primary end point(s): DFS in PD-L1 TC=1% (using Investigator assessments according to RECIST 1.1);Timepoint(s) of evaluation of this end point: Approximately 3 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. DFS in FAS (using Investigator assessments according to RECIST 1.1) 2. DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC=1% and in FAS 3. PFS (using local standard practice) 4. Time to first subsequent therapy (TFST) 5. Time to second subsequent therapy (TSST) 6. OS in PD-L1 TC=1% and in FAS 7. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13 8. IHC analysis of PD-L1 TC expression and spatial distribution within the tumor microenvironment relative to efficacy outcomes (ie, DFS, OS);Timepoint(s) of evaluation of this end point: Approximately 5 years	—

Measure

Time frame

Secondary end point(s): 1. DFS in FAS (using Investigator assessments according to RECIST 1.1) 2. DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC=1% and in FAS 3. PFS (using local standard practice) 4. Time to first subsequent therapy (TFST) 5. Time to second subsequent therapy (TSST) 6. OS in PD-L1 TC=1% and in FAS 7. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13 8. IHC analysis of PD-L1 TC expression and spatial distribution within the tumor microenvironment relative to efficacy outcomes (ie, DFS, OS);Timepoint(s) of evaluation of this end point: Approximately 5 years

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Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Peru, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Viet Nam

Contacts

Public ContactInformation Center

Astra Zeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026