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)

Trial number:
NCT04385368
Trial phase:
3
Study type:
Immunotherapy
Overall status:
Recruiting

Study start date

July, 2020

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)

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

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 protocolAge ≥18 years at the time of screening Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease Complete resection of the primary NSCLC

Postoperative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrenceEGFR-mutant and/or ALK-translocation Mixed small cell and NSCLC histology Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Quadruple, Masking description: Double- Blind, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes, Outcomes assessor masked: Yes,

Conditions

Carcinoma, Non-Small-Cell Lung

Other study ID numbers

D910LC00001

Choose trial site (518)

National University Hospital 119228
National University Hospital 119228 Withdrawn
1E Kent Ridge Rd, Singapore 119228
National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
11 Hospital Crescent, Singapore 169610
Tan Tock Seng Hospital Singapore
Tan Tock Seng Hospital Singapore Not yet recruiting
11 Jln Tan Tock Seng, Level 1, Singapore 308433