NCT05170204

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Alectinib	Participants will receive oral alectinib twice daily with food.
DRUG	Entrectinib	Participants will receive oral entrectinib once daily, with or without food.
DRUG	Durvalumab	Participants will receive IV durvalumab every 4 weeks.

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-12-20
• Completion: 2030-06-19
• First posted: 2021-12-27
• Last updated: 2026-03-06

Locations

45 sites across 19 countries: United States, Australia, Belgium, Brazil, Chile, China, Colombia, France, Germany, Italy, Japan, Mexico, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study