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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Advanced lung cancer, MET gene mutations

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No treatment is included in this protocol.

    Other intervention

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

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: ICIs1 intervention
Group B: Savolitinib1 intervention
Group C: Glumetinib1 intervention
Group D: Bozitinib1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Assessed up to around 4.5 years
2

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

Time frame
Assessed up to around 4.5 years

Secondary outcomes

1

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.

Time frame
Assessed up to around 4.5 years
2

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.

Time frame
Assessed up to around 4.5 years
3

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.

Time frame
Assessed up to around 4.5 years

Other outcomes

Sponsors and contacts

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