Phase III study to determine the efficacy of Durvalumab in combination with chemotherapy in completely resected stage II-III non-small cell lung cancer.

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) - MERMAID-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000556-35-DK

Enrollment

332

Registered

2020-05-18

Start date

2020-06-24

Completion date

Unknown

Last updated

2023-12-04

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 232 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in all patients 2. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using BICR assessments according to RECIST 1.1 in MRD+ patients and in all patients 3. 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. To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy 5. To assess the PK of durvalumab 6. To investigate the immunogenicity of durvalumab;Primary end point(s): DFS in MRD+ analysis set (using Investigator assessments according to RECIST 1.1);Timepoint(s) of evaluation of this end point: Approximately 4 years;Main Objective: To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in MRD+ patients	—

Measure

Time frame

Secondary Objective: 1. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in all patients 2. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using BICR assessments according to RECIST 1.1 in MRD+ patients and in all patients 3. 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. To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy 5. To assess the PK of durvalumab 6. To investigate the immunogenicity of durvalumab;Primary end point(s): DFS in MRD+ analysis set (using Investigator assessments according to RECIST 1.1);Timepoint(s) of evaluation of this end point: Approximately 4 years;Main Objective: To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in MRD+ patients

—

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 MRD+ analysis set and in FAS 3. OS in MRD+ analysis set and in FAS 4. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13 5.Concentration of durvalumab 6. Presence of ADAs for durvalumab;Timepoint(s) of evaluation of this end point: Approximately 6 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 MRD+ analysis set and in FAS 3. OS in MRD+ analysis set and in FAS 4. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13 5.Concentration of durvalumab 6. Presence of ADAs for durvalumab;Timepoint(s) of evaluation of this end point: Approximately 6 years

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Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, 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