NCT04642469

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

Detailed description

This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during surveillance period.

Conditions

• Carcinoma, Non- Small Cell Lung

Interventions

Type	Name	Description
DRUG	Durvalumab	Intravenous administration of Durvalumab
OTHER	Placebo	Placebo Comparator

Timeline

• Start date: 2020-11-30
• Primary completion: 2023-05-31
• Completion: 2024-01-15
• First posted: 2020-11-24
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

115 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Peru, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study