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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Other: No treatment is included in this protocol.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yongchang Zhang, MD; Phone Number: 7+861383123436 +8613873123436; Email: zhangyongchang@csu.edu.cn
• Study Contact Backup: Name: Nong Yang; Phone Number: +8613873123436; Email: yangnong0217@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Province Tumor Hospital
      • Contact: Ming Zhou, MD; Phone Number: +86 731 89762321; Email: zhouming243@gmail.com
      • Contact: Nong Yang, MD; Phone Number: +86 731 89762323; Email: yangnong0217@163.com
      • Principal Investigator: Nong Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Advanced lung cancer, MET gene mutations

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICIs; Patients receiving in first-line immunotherapy with or without anti-angiogenic or chemotherapy	Other: No treatment is included in this protocol.; No drug intervention or tissue sampling will be included in this study.
Savolitinib; Patients receiving in first-line savolitinib treatment	Other: No treatment is included in this protocol.; No drug intervention or tissue sampling will be included in this study.
Glumetinib; Patients receiving in first-line glumetinib treatment	Other: No treatment is included in this protocol.; No drug intervention or tissue sampling will be included in this study.
Bozitinib; Patients receiving in first-line bozitinib treatment	Other: No treatment is included in this protocol.; No drug intervention or tissue sampling will be included in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 23, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: MET RWS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No