NCT03822351

Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Detailed description

Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).

Conditions

• Stage III Non-small Cell Lung Cancer
• Unresectable

Interventions

Type	Name	Description
DRUG	Durvalumab + Oleclumab	Durvalumab + Oleclumab
DRUG	Durvalumab	Durvalumab
DRUG	Durvalumab + Monalizumab	Durvalumab + Monalizumab

Timeline

• Start date: 2018-12-19
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2019-01-30
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

73 sites across 9 countries: United States, Canada, France, Hong Kong, Italy, Poland, Portugal, Spain, Taiwan

Regulatory

• FDA-regulated drug study