Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC

Launched by NATIONAL CANCER CENTER, CHINA · Nov 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a targeted therapy called entrectinib in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The goal is to see how effective and safe entrectinib is for patients who have this specific type of cancer, especially looking at how it works in the brain and what happens if a patient develops resistance to the treatment. This is an observational study, meaning that it won’t change your usual treatment plan, but your medical information will be collected to help improve future treatments for others with the same condition.

To be eligible for this trial, participants must be adults aged 18 or older with confirmed advanced NSCLC that has a specific gene change known as ROS1 fusion. They should not have received any previous treatments for their cancer, like chemotherapy or surgery. The study will include three groups based on previous treatments: those who haven’t had any targeted therapy, those who progressed after a first-generation treatment, and those who have tried multiple treatments without success. Participants can expect regular follow-ups and monitoring of their health during the trial, and they will also have the opportunity to receive genetic testing if they develop resistance to entrectinib.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) Histologically or cytologically confirmed non-small cell lung cancer;
• • 2) TNM stage of the ninth edition is IIIB, IIIC, or IV;
• • 3) ROS1 fusion positive confirmed by one of the following qualified results: next-generation sequencing technology, fluorescence in situ hybridization, reverse transcription polymerase chain reaction;
• • 4) No prior systemic chemotherapy, radiation therapy, or surgery;
• • 5) Aged 18 years or older;
• • 6) ECOG PS score of 0-1.
• Exclusion Criteria:
• • 1) any prior history of NSCLC and/or any prior treatment for NSCLC;
• • 2) prior systemic chemotherapy or radiation therapy or surgical treatment;
• • 3) the presence of a second primary tumor;
• • 4) hypersensitivity to ROS1-TKI or intolerance to it.