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NCT Number: NCT06183762

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

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).

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Key information

Conditions

Advanced Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No treatment is included in this protocol.

Other

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

Primary outcomes

  1. Progression-Free-Survival

    Time frame: Assessed up to around 4.5 years

    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

  2. Overall Survival

    Time frame: Assessed up to around 4.5 years

    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

Secondary outcomes

  1. Clinical relevance between genomic profiling and progression-free-survival

    Time frame: Assessed up to around 4.5 years

    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.

  2. Clinical relevance between genomic profiling and overall survival

    Time frame: Assessed up to around 4.5 years

    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.

  3. ORR

    Time frame: Assessed up to around 4.5 years

    Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements.

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang

CONTACT

[email protected]

+8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Dec 28, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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