Primary Resistance Mechanisms of ALK TKIs

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jun 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying why some patients with a specific type of lung cancer—called ALK-positive non-small cell lung cancer (NSCLC)—do not respond well to a group of targeted treatments known as ALK inhibitors. These medicines usually work well and help patients live longer, but in a small number of cases, the cancer quickly stops responding within 3 to 6 months. This early lack of response is called “primary resistance.” The study aims to better understand the reasons behind this resistance by analyzing tumor samples to look for genetic changes that might explain why the treatment isn’t working.

Adults with ALK-positive advanced NSCLC who start ALK inhibitor treatment but experience disease progression or no improvement within the first 3 to 6 months may be eligible to take part. Participants will be asked to provide new tumor samples for genetic testing to help researchers identify the causes of resistance. This study is not yet recruiting, but those interested should be willing to undergo biopsy or blood sample collection and able to give informed consent. The information gained from this study could help doctors develop better treatment strategies for patients whose cancer doesn’t respond to current ALK inhibitor therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old.
• • 2. Histologically or cytologically diagnosed NSCLC
• • 3. ALK gene fusion detected at initial diagnosis of NSCLC
• • 4. Patients exhibiting primary resistance to ALK-TKI therapy, defined as the absence of initial response or progression within 3 to 6 months of treatment initiation, were included.
• • 5. Able and willing to provide written informed consent prior to performing any study related procedures and to comply with the study protocol.
• Exclusion Criteria:
• • 1. Unable to provide written inform consent
• • 2. The patients had received other systemic treatments except ALK TKI.
• • 3. Unable to undergo tumor biopsy or venipuncture