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

NCT06694129 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: NCC4601
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Non-Small Cell Lung Cancer; ROS1 Gene Rearrangement; Targeted therapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From enrollment to the end of treatment at 1 year.

Secondary Outcomes (3)

• Objective remission rate

  From enrollment to the end of treatment at 1 year.

• Time to CNS progression

  From enrollment to the end of treatment at 1 year.

• Overall survival

  From enrollment to the end of treatment at 1 year.

Other Outcomes (1)

• Exploratory biomarker analysis

  From enrollment to the end of treatment at 1 year.

Study Arms (3)

Cohort 1

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

Drug: Entrectinib

Cohort 2

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.

Drug: Entrectinib

Cohort 3

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

Drug: Entrectinib

Interventions

Entrectinib DRUG

Patients in each cohort were treated with Entrectinib.

Also known as: Rozlytrek

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with non-small cell lung cancer exhibiting ROS1 rearrangement.

You may qualify if:

• \) Histologically or cytologically confirmed non-small cell lung cancer;
• \) TNM stage of the ninth edition is IIIB, IIIC, or IV;
• \) ROS1 fusion positive confirmed by one of the following qualified results: next-generation sequencing technology, fluorescence in situ hybridization, reverse transcription polymerase chain reaction;
• \) No prior systemic chemotherapy, radiation therapy, or surgery;
• \) Aged 18 years or older;
• \) ECOG PS score of 0-1.

You may not qualify if:

• \) any prior history of NSCLC and/or any prior treatment for NSCLC;
• \) prior systemic chemotherapy or radiation therapy or surgical treatment;
• \) the presence of a second primary tumor;
• \) hypersensitivity to ROS1-TKI or intolerance to it.

Sponsors & Collaborators

• National Cancer Center, China: lead

Biospecimen

Retention: SAMPLES WITH DNA

Tissue specimens or blood after resistance to entrectinib.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

entrectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Puyuan Xing

CONTACT

+86 135 2100 5935; xingpuyuan@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share