Non Small Cell Lung CancerNCT04777175
A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Yongchang Zhang at 2 sites in China.
Trial summary
In advanced non-small cell lung cancer, there will be some rare mutations, such as ALK, KRAS, etc. The efficacy of these immunotherapies on these different rare mutations has not been reported. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- immunity therapy
- How many people
- 186 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 12 Jan 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced non-small-cell lung cancer carrying KRAS, ALK, ERBB2, MET, RET, BRAF mutation.
Who may be able to join
- 1.Diagnosed as advanced non-small cell lung cancer
- 2.Confirmed as KARS, ALK, ERBB2, MET, RET, BRAF mutation
Who cannot join
- The patient is diagnosed with small cell lung cancer
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Nong Yang, MD, +86 731 89762323, yangnong0217@163.com
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
- Recruiting
Hunan Cancer hospital
Changsha, Hunan
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
About this study
In advanced non-small cell lung cancer, there will be some rare mutations, such as ALK, KRAS, etc. The efficacy of these immunotherapies on these different rare mutations has not been reported. Therefore, we conducted this retrospective clinical study to explore the efficacy of immunotherapy for different rare mutations.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- immunity therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunity therapyDrug
The patient receives immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| KRAS mutation | patients carry with KRAS mutation Receives: Drug: immunity therapy | |
| ALK fusion | patients carry with ALK fusion Receives: Drug: immunity therapy | |
| ERBB2 mutation | patients carry with ERBB2 mutation Receives: Drug: immunity therapy | |
| MET skipping/amplication | patients carry with MET skipping/amplication Receives: Drug: immunity therapy | |
| RET fusion | patients carry with RET fusion Receives: Drug: immunity therapy | |
| BRAF mutation | patients carry with BRAF mutation Receives: Drug: immunity therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Measured: January 2021- January 2021 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion12 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell 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
- Retrospective
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongchang Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Province Tumor Hospital
- Responsible party
- Sponsor-investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777175
- Sponsor's protocol ID
- IRMLC
- Status last verified
- Sep 2024
- First submitted
- 27 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04777175
- Acronym / sponsor ID
- IRMLC
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Yongchang ZhangUniversity, hospital or other
- Collaborators
- Hunan Province Tumor Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 12 Jan 2025 (estimated)
- First posted
- 2 Mar 2021 (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.
In advanced non-small cell lung cancer, there will be some rare mutations, such as ALK, KRAS, etc. The efficacy of these immunotherapies on these different rare mutations has not been reported. Therefore, we conducted this retrospective clinical study to explore the efficacy of immunotherapy for different rare mutations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| KRAS mutation | – | Drug: immunity therapypatients carry with KRAS mutation |
| ALK fusion | – | Drug: immunity therapypatients carry with ALK fusion |
| ERBB2 mutation | – | Drug: immunity therapypatients carry with ERBB2 mutation |
| MET skipping/amplication | – | Drug: immunity therapypatients carry with MET skipping/amplication |
| RET fusion | – | Drug: immunity therapypatients carry with RET fusion |
| BRAF mutation | – | Drug: immunity therapypatients carry with BRAF mutation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced non-small-cell lung cancer carrying KRAS, ALK, ERBB2, MET, RET, BRAF mutation.
Key inclusion criteria (2 listed)
- 1.Diagnosed as advanced non-small cell lung cancer
- 2.Confirmed as KARS, ALK, ERBB2, MET, RET, BRAF mutation
Key exclusion criteria (1 listed)
- The patient is diagnosed with small cell lung cancer
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 |
|---|---|---|
| immunity therapyThe patient receives immunotherapy | Drug | ALK fusion, BRAF mutation, ERBB2 mutation, KRAS mutation, MET skipping/amplication, RET fusion |
Primary outcome
PFS
Time frame: January 2021- January 2021 (1 year)
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
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.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Yongchang Zhang at 2 sites 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 2 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 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: January 2021- January 2021 (1 year)). 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.