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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)

Overview

Overview

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

Key Inclusion Criteria

Key Inclusion 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
Key Exclusion Criteria

Key Exclusion Criteria

  • 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
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Phase III

Principal Investigator(s)

Vikas Dembla, MD

Sponsor(s)

AstraZeneca

Contact Us

Contact Us

To participate in this study, please contact Sue Stanley, RN at
864-560-7252