A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients with Minimal Residual Disease Following Surgery and Curative Intent Therapy (MERMAID-2)

Phase 3

• Conditions: lung cancer; 10038666; non small-cell lung cancer

• Registration Number: NL-OMON52301
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

• Histologically confirmed NSCLC with resectable stage II-III disease who have
undergone curative intent
therapy (complete resection of the primary tumor ± neoadjuvant and/or adjuvant
therapy) per SoC
• A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and
adrenal glands) along with brain MRI must have been done for surgical planning
prior to surgery
• Complete resection of the primary NSCLC is mandatory
• Patients should have completed curative intent therapy
• Confirmation of suitable resected tumor tissue and whole blood sample
• Post-adjuvant therapy or post-operative CT scan of the chest and abdomen and
brain MRI
• Consents to be accessible for q6w plasma sample collection for MRD evaluation
and for q12w CT scans during the 96-week surveillance period

Inclusion criteria for second screening period:
• CT scan of the chest and abdomen and brain MRI performed within the 28 days
prior to randomization to confirm no evidence of RECIST 1.1-defined disease
recurrence and/or metastasis
• Complete post-operative wound healing
• Must have recovered from all acute, reversible toxic effects from chemotherapy
• Adequate organ and marrow function
• Must have a life expectancy of at least 12 weeks

Exclusion Criteria

Unequivocal evidence of disease recurrence or tissue biopsy-proven disease
recurrence
• EGFR-mutant and/or ALK-translocation
• Mixed small cell and NSCLC histology
• Require re-resection or are deemed to have unresectable NSCLC by a
multidisciplinary evaluation that must
include a thoracic surgeon who performs lung cancer surgery as a significant
part of their practice.
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness (see protocol page 67)
• History of another primary malignancy (check for exceptions)
• History of active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C virus or HIV
• Received any IO therapy in the adjuvant setting or any prior exposure to
durvalumab
• Received any radiotherapy in the neoadjuvant setting
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
treatment (with exceptions)
• Current or prior use of immunosuppressive medication within 14 days before
the first dose of IP (with exceptions)

Study & Design

• Study Type: Interventional
• Study Design: Not specified