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

Advanced Lung Cancer Clinical Trial

Official title:

Real-World Treatment Patterns and Effectiveness of Targeted and Systemic Therapy in Patients With Advanced Lung Cancer Carrying MET Mutation-Positive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183762
• Other study ID #: MET RWS
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Intervention

Other:
• No treatment is included in this protocol.
No drug intervention or tissue sampling will be included in this study.

Locations

Country	Name	City	State
China	Hunan Province Tumor Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival	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	Assessed up to around 4.5 years
Primary	Overall Survival	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	Assessed up to around 4.5 years
Secondary	Clinical relevance between genomic profiling and progression-free-survival	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.	Assessed up to around 4.5 years
Secondary	Clinical relevance between genomic profiling and overall survival	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.	Assessed up to around 4.5 years
Secondary	ORR	Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements.	Assessed up to around 4.5 years