Advanced Lung CancerNCT06183762
A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer
An observational study of Advanced Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- No treatment is included in this protocol.
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced lung cancer, MET gene mutations
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Province Tumor Hospital
Changsha, Hunan
Nong Yang, MD, +86 731 89762323, yangnong0217@163.com
Ming Zhou, MD, +86 731 89762321, zhouming243@gmail.com
About this study
Official title: 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).
- Conditions
- Advanced Lung Cancer
- Being tested
- No treatment is included in this protocol.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment is included in this protocol.Other
No drug intervention or tissue sampling will be included in this study.
| Study group | Role | What they receive |
|---|---|---|
| ICIs | Patients receiving in first-line immunotherapy with or without anti-angiogenic or chemotherapy Receives: Other: No treatment is included in this protocol. | |
| Savolitinib | Patients receiving in first-line savolitinib treatment Receives: Other: No treatment is included in this protocol. | |
| Glumetinib | Patients receiving in first-line glumetinib treatment Receives: Other: No treatment is included in this protocol. | |
| Bozitinib | Patients receiving in first-line bozitinib treatment Receives: Other: No treatment is included in this protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Assessed up to around 4.5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Assessed up to around 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183762
- Sponsor's protocol ID
- MET RWS
- Status last verified
- Sep 2024
- First submitted
- 4 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Effectiveness of Targeted and Systemic Therapy in Patients With Advanced Lung Cancer Carrying MET Mutation-Positive
- ClinicalTrials.gov ID
- NCT06183762
- Acronym / sponsor ID
- MET RWS
- Conditions
- Advanced Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICIs | – | Other: No treatment is included in this protocol.Patients receiving in first-line immunotherapy with or without anti-angiogenic or chemotherapy |
| Savolitinib | – | Other: No treatment is included in this protocol.Patients receiving in first-line savolitinib treatment |
| Glumetinib | – | Other: No treatment is included in this protocol.Patients receiving in first-line glumetinib treatment |
| Bozitinib | – | Other: No treatment is included in this protocol.Patients receiving in first-line bozitinib treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced lung cancer, MET gene mutations
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment is included in this protocol.No drug intervention or tissue sampling will be included in this study. | Other | Bozitinib, Glumetinib, ICIs, Savolitinib |
Primary outcome
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
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
3 secondary outcomes
Clinical relevance between genomic profiling and progression-free-survival
Time frame: Assessed up to around 4.5 years
Clinical relevance between genomic profiling and overall survival
Time frame: Assessed up to around 4.5 years
ORR
Time frame: Assessed up to around 4.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongchang Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: Assessed up to around 4.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.