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)

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)

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

Closed

Thoracic Cancer

Learn More

To learn more, visit ClinicalTrials.Gov or contact Clinical Research at 864-560-6812.

Principal Investigator(s)

Vikas Dembla, MD

Sponsor(s)

AstraZeneca

Key Trial Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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
- Age ≥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 recurrence
- EGFR-mutant and/or ALK-translocation
- Mixed small cell and NSCLC histology
- Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab

Clinical Research Trials

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)

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)

Key Trial Criteria

Key Inclusion Criteria

Key Exclusion Criteria