Clinical trial NCT06694129: Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC
Official title: Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-Small Cell Lung Cancer
ROS1 Gene Rearrangement
Resistance
Targeted Therapy
Keywords: Non-Small Cell Lung Cancer
ROS1 Gene Rearrangement
Targeted therapy
Lead sponsor: National Cancer Center, China
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-small cell lung cancer exhibiting ROS1 rearrangement.

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Progression free survival
timeFrame: From enrollment to the end of treatment at 1 year.
Secondary outcomes:
measure: Objective remission rate
timeFrame: From enrollment to the end of treatment at 1 year.
measure: Time to CNS progression
timeFrame: From enrollment to the end of treatment at 1 year.
measure: Overall survival
timeFrame: From enrollment to the end of treatment at 1 year.
Other outcomes:
measure: Exploratory biomarker analysis
timeFrame: From enrollment to the end of treatment at 1 year.
Locations:
Study officials:
References: