NCT06624059

A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Alectinib	Participants will receive oral alectinib twice daily (BID) for up to 2 years.
DRUG	Cisplatin	Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
DRUG	Carboplatin	Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
DRUG	Pemetrexed	Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-08-28
• Completion: 2026-08-28
• First posted: 2024-10-02
• Last updated: 2026-04-08

Locations

11 sites across 6 countries: Australia, Brazil, Chile, China, Italy, South Korea

Regulatory

• FDA-regulated drug study