Trial Number

035-20

Condition

Lung Cancer

Participant Age Range

18 years and older

Participant Gender

Any

Enrolling Participants

No

Overview

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)

Up to 30% of patients with non-small cell lung cancer (NSCLC) present with surgically resectable disease. Adjuvant chemotherapy following resection of NSCLC is standard practice to reduce risk of disease recurrence. However, it is challenging to determine who will benefit from adjuvant chemotherapy. There is evidence that identification of minimal residual disease (MRD) through detection of circulating tumor DNA (ctDNA) post-surgery can accurately predict disease recurrence. Data suggest that the combination of immunotherapy and chemotherapy in the adjuvant setting, where patients have undergone a complete resection but may have residual disease, may provide additional benefits to single agent immunotherapy and improve disease-free survival (DFS). This study aims to exploit the emerging clinical value of MRD as an adjuvant biomarker for risk of disease recurrence to inform targeted escalation of adjuvant therapy only in patients with evidence of residual disease post-surgery who are thus at high risk for disease recurrence while preventing overtreatment of MRD-negative patients, the majority of whom have been cured by surgery alone. The research hypothesis for this study is that concurrent durvalumab plus standard of care chemotherapy will be more effective than placebo plus standard of care chemotherapy for the treatment of MRD-positive patients who have undergone complete resection of stage II-III NSCLC when administered in the adjuvant setting.

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