A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Preoperative Brigatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Fusions.

• Status: Not yet recruiting
• Trial end date: 2024-06-01

Summary

This study is single arm, open label, phase II trial for resectable ALK+ NSCLC. Eligible patients will receive brigatinib after 7-day lead-in 90mg from 4 to 10 weeks.

The objective of this study is as follows.

• Primary objective: To identify molecular mechanism of DTP causing innate drug resistance to neoadjuvant brigatinib in resectable NSCLC harboring ALK fusion by analyzing single cell RNA-seq.

• Secondary objectives:

1. To assess the pathologic response rate to neoadjuvant treatment with Brigatinib

2. To evaluate the clinical efficacy in resectable ALK-positive NSCLC patients treated with brigatinib induction therapy

3. To evaluate the successful curative resection rate

4. To evaluate the safety of brigatinib as neoadjuvant treatment in resectable ALK-rearranged NSCLC patients.

5. To investigate the changes of ALK rearrangement and other hot spot mutations by GUARDANT LUNAR assay of circulating tumor DNA present in blood plasma immediately with serial sampling.

6. To assess of variant allele frequencies between pre-treatment and post-treatment sampling by GUARDANT LUNAR assay

7. To explore cell-free biomarkers that may be predictive of response or primary resistance to brigatinib neoadjuvant therapy

• Phase: Phase 2

Details

• Lead Sponsor: Yonsei University