NCT06522360

Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. The safety of these combinations will also be studied.

Detailed description

To compare the 2-year PFS rate of ALK+ NSCLC patients treated with brigatinib to those treated with brigatinib and local consolidation therapy (LCT). To compare the 2-year PFS rate of ALK+ NSCLC patients treated with brigatinib to those treated with brigatinib and chemotherapy. To assess the safety and tolerability of brigatinib and LCT. To assess the safety and tolerability of brigatinib and chemotherapy. To increase trial enrollment in underserved population. To determine overall survival (OS) in patients treated with single agent brigatinib, brigatinib plus LCT and brigatinib plus chemotherapy. To assess the time to progression of non-LCT lesions in the brigatinib plus LCT arm.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Brigatinib	Given by mouth
DRUG	Carboplatin	Given by mouth
DRUG	Pemetrexed	Given by vein

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-04-17
• Completion: 2025-04-17
• First posted: 2024-07-26
• Last updated: 2025-04-24

Regulatory

• FDA-regulated drug study