NCT03794544

Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 102 Years
• Healthy volunteers: Not accepted

Summary

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I \[\>2cm\] to IIIA) non-small cell lung cancer (NSCLC).

Conditions

• Resectable
• Early-stage
• NSCLC

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
COMBINATION_PRODUCT	Oleclumab	Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
COMBINATION_PRODUCT	Monalizumab	Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
COMBINATION_PRODUCT	Danvatirsen	Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Timeline

• Start date: 2019-03-08
• Primary completion: 2021-01-13
• Completion: 2021-01-13
• First posted: 2019-01-07
• Last updated: 2022-02-24
• Results posted: 2022-02-24

Locations

18 sites across 7 countries: United States, Canada, France, Italy, Portugal, Spain, Switzerland

Regulatory

• FDA-regulated drug study