NCT06694129Not yet recruiting
Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC
Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 3 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- National Cancer Center, China
- Diseases
- Lung cancer
- NCT number
- NCT06694129
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 Dec 2024 to the primary completion date, 1 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\) any prior history of NSCLC and/or any prior treatment for NSCLC;
- 2\) prior systemic chemotherapy or radiation therapy or surgical treatment;
Other illness
- 4\) hypersensitivity to ROS1-TKI or intolerance to it.
Other
- 3\) the presence of a second primary tumor;
Who the study is looking for
- 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.
Age in the registry: 18 years to 86 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.