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

Study Overview
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Brief Summary
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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).

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

Conditions
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Advanced Lung Cancer

Intervention / Treatment
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* Other: No treatment is included in this protocol.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |