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

NCT06183762 | Recruiting

• 1 other identifier: MET RWS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Clinical relevance between genomic profiling and progression-free-survival

  Assessed up to around 4.5 years

• Clinical relevance between genomic profiling and overall survival

  Assessed up to around 4.5 years

• ORR

  Assessed up to around 4.5 years

Study Arms (4)

ICIs

Patients receiving in first-line immunotherapy with or without anti-angiogenic or chemotherapy

Other: No treatment is included in this protocol.

Savolitinib

Patients receiving in first-line savolitinib treatment

Other: No treatment is included in this protocol.

Glumetinib

Patients receiving in first-line glumetinib treatment

Other: No treatment is included in this protocol.

Bozitinib

Patients receiving in first-line bozitinib treatment

Other: No treatment is included in this protocol.

Interventions

No treatment is included in this protocol. OTHER

No drug intervention or tissue sampling will be included in this study.

Bozitinib; Glumetinib; ICIs; Savolitinib

Eligibility Criteria

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

Study Population

Advanced lung cancer, MET gene mutations

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Province Tumor Hospital

Changsha, Hunan, China

RECRUITING

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Director of Thoracic Oncology Department

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 28, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)