Durvalumab and Chemotherapy in Resected Non Small Cell Lung Cancer
Research type
Research Study
Full 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)
IRAS ID
279274
Contact name
Gary Middleton
Contact email
Sponsor organisation
AstraZeneca UK Ltd.
Eudract number
2020-000556-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 23 days
Research summary
This double-blind placebo-controlled phase 3 trial is evaluating the efficacy of durvalumab + chemotherapy followed by durvalumab versus placebo + chemotherapy followed by placebo in patients with stage II-III non-small cell lung cancer (NSCLC) who have minimal residual disease (MRD) after complete resection.
Study participants will undergo screening, treatment, and follow-up.
Eligible patients are males and/or females ≥18 years old whose tumours are EGFR/ALK wild-type; who meet all eligibility criteria; and who consent to participate in the study.
Screening can last up to 12 weeks after surgery and may require several visits. During this screening period, a personalized panel for detection of MRD will be developed based on whole exome sequencing data (WES) from the patient’s tumour and whole blood samples. A blood sample collected after surgery will be tested using this personalized panel. Approximately 232 patients who are MRD positive
based on this blood test may be eligible for randomization provided all other eligibility criteria are met.Approximately 100 MRD-negative patients will also be randomized into the study. Patients eligible for randomization will be assigned to 1 of 2 treatment groups by a computer program.
Approximately 332 patients will be randomized 1:1 to either durvalumab plus chemotherapy or placebo plus chemotherapy for the first 4 cycles; patients will then receive either durvalumab or placebo alone for up to an additional 10 cycles. During the 12 month treatment period, patients will be required to come to the clinic for treatment, study procedures, and collection of samples.
Patients will receive treatment until completion of 12 months of treatment; discontinuation of treatment for any reason; or if a tumour is identified on a scan, whichever occurs first.
After a patient ends treatment, they will enter a follow-up period until the end of the study. This study is expected to last approximately 6 years.
REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/1141
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion