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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04385368




Registration number
NCT04385368
Ethics application status
Date submitted
30/04/2020
Date registered
12/05/2020
Date last updated
5/05/2021

Titles & IDs
Public title
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)
Scientific 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)
Secondary ID [1] 0 0
D910LC00001
Universal Trial Number (UTN)
Trial acronym
MERMAID-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab + SoC chemotherapy
Other interventions - Placebo + SoC chemotherapy

Experimental: Durvalumab + SoC chemotherapy - Intravenous administration of Experimental and Standard of Care Therapy

Placebo Comparator: Placebo + SoC chemotherapy - Intravenous administration of Placebo and Standard of Care Therapy


Treatment: Drugs: Durvalumab + SoC chemotherapy
Experimental Treatment

Other interventions: Placebo + SoC chemotherapy
Placebo Comparator

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival (DFS) in MRD+ analysis set (using Investigator assessments according to RECIST 1.1) - To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients
Timepoint [1] 0 0
approximately 4 years
Secondary outcome [1] 0 0
DFS in FAS (using Investigator assessments according to RECIST 1.1) - To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in all patients
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [2] 0 0
DFS (using BICR assessments according to RECIST 1.1) in MRD+ analysis set and in FAS - To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS in MRD+ patients and in all patients
Timepoint [2] 0 0
Approximately 4 years
Secondary outcome [3] 0 0
OS in MRD+ analysis set and in FAS - To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by OS in MRD+ patients and in all patients
Timepoint [3] 0 0
Approximately 6 years
Secondary outcome [4] 0 0
Concentration of durvalumab - To assess the PK of durvalumab
Timepoint [4] 0 0
Approximately 4 years
Secondary outcome [5] 0 0
Presence of ADAs for durvalumab - To investigate the immunogenicity of durvalumab
Timepoint [5] 0 0
Approximately 4 years
Secondary outcome [6] 0 0
Change from baseline in EORTC QLQ-LC13 score - To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy
Timepoint [6] 0 0
Approximately 4 years
Secondary outcome [7] 0 0
Time to deterioration in EORTC QLQ-LC13 score - To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy
Timepoint [7] 0 0
Approximately 4 years
Secondary outcome [8] 0 0
Change from baseline in EORTC QLQ-C30 score - To assess patient-reported symptoms, functioning and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy
Timepoint [8] 0 0
Approximately 4 years
Secondary outcome [9] 0 0
Time to deterioration in EORTC QLQ-C30 score - To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy
Timepoint [9] 0 0
Approximately 4 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
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Hochiminh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT04385368
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Solange Peters
Address 0 0
Centre Hospitalier Universitaire Vaudois (CHUV)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04385368