A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer

Recruiting

• Conditions: Advanced Lung Cancer

• Registration Number: NCT06183762
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data will be collected in a forward-looking manner. This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. The criteria for retrospective collection were consistent with those for prospective collection. Eligible patients will be enrolled after NGS analysis of tumor tissue and informed consent has been obtained. Information required for the study will be collected (every 3 months).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-23
• Last Update Submitted: 2023-12-23
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients must be ≥18 years of age.
2. Provision of fully informed consent prior to any study specific procedures.
3. Histologically or cytologically confirmed, unresectable stage IIIB/IIIC or stage IV NSCLC.
4. Genetic variants of tumor tissue detected by NGS.

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free-Survival	Assessed up to around 4.5 years	From the time the first patient included in the observational analysis received treatment until disease progression, death due to various causes or censored at the date of last contact
Overall Survival	Assessed up to around 4.5 years	From the time the first patient included in the observational analysis received treatment until death due to various causes or censored at the date of last contact

Secondary Outcome Measures

Name	Time	Method
ORR	Assessed up to around 4.5 years	Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements.
Clinical relevance between genomic profiling and overall survival	Assessed up to around 4.5 years	Kaplan-Meier analysis for overall survival, utilizing data from various genetic testing methods including NGS and FISH, to evaluate the impact of different genetic alterations.
Clinical relevance between genomic profiling and progression-free-survival	Assessed up to around 4.5 years	Kaplan-Meier analysis for progression-free survival, utilizing data from various genetic testing methods including NGS and FISH, to evaluate the impact of different genetic alterations.

Trial Locations

Locations (1)

Hunan Province Tumor Hospital; 🇨🇳 Changsha, Hunan, China