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

National Cancer Center, China

Status: Not yet enrolling

Conditions: Targeted Therapy; ROS1 Gene Rearrangement; Resistance; Non-Small Cell Lung Cancer

Treatments: Drug: Entrectinib

Study type: Observational

Funder types: Other

Identifiers

NCT06694129

NCC4601

Details and patient eligibility

About

The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.

Full description

The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of entrectinib's brain protection and resistance mechanism. Because this study is a non-interventional study, it will not interfere with your usual treatment. However, your medical data will be analyzed, and the results will help improve future treatment options for ROS1 positive NSCLC patients and improve their quality of life.This study was divided into three cohorts. Cohort 1: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had not received TKI treatment, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 2: For patients with advanced ROS1-positive NSCLC who met the inclusion criteria and had received first-generation ROS1 TKI treatment with disease progression on crizotinib, they were treated with entrectinib until disease progression or intolerance (N=15); Cohort 3: For patients with ROS1-positive NSCLC who had failed multiple lines of treatment, they were treated with entrectinib until disease progression or intolerance (N=10). Regular follow-up was conducted and relevant clinical data were recorded, followed by Cox regression analysis and survival analysis. The information that needs to be recorded includes baseline and treatment genetic testing, demographic information, anti-cancer history, and concomitant medication use, as well as the use of study drugs and adverse events during treatment visits, survival and subsequent drug use after discharge, and the follow-up frequency consistent with clinical practice. Subjects are eligible for a complimentary NGS test upon the development of entrectinib resistance.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 86 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 3 patient groups

Cohort 1

Description:

For eligible patients with advanced ROS1-positive NSCLC who have not received TKI treatment, receive entrectinib therapy until disease progression or intolerance.

Treatment:

Drug: Entrectinib

Cohort 2

Description:

For patients with NSCLC who have progressed after receiving first-generation ROS1 TKI crizotinib and meet the eligibility criteria, they can receive entrectinib treatment until disease progression or intolerance.

Treatment:

Drug: Entrectinib

Cohort 3

Description:

For patients with ROS1-positive NSCLC who have failed multi-line therapy, receive entrectinib until disease progression or intolerance.

Treatment:

Drug: Entrectinib