SMARCA4-Deficient TumorNCT07121387
A Retrospective Cohort Analysis of SMARCA4-Deficient Lung Cancer
An observational study of SMARCA4-Deficient Tumor and NSCLC (Advanced Non-small Cell Lung Cancer), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This is a single-center retrospective analysis to explore the clinical characteristics, therapeutic efficacy, and tumor immune microenvironment of SMARCA4-deficient advanced non-small-cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SMARCA4-Deficient Tumor, NSCLC (Advanced Non-small Cell Lung Cancer)
- How many people
- 221 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 17 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The clinical information of 221 patients with advanced non-small cell lung cancer from the Department of Oncology of Shanghai Pulmonary Hospital.
Who may be able to join
- Diagnosed with stage III-IV NSCLC according to the American Joint Committee on Cancer staging criteria (7th edition);
- Lesions are measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- Receiving first-line immunotherapy or chemotherapy as anti-tumor treatment.
Who cannot join
- SMARCA4 gene test was not performed;
- Not receive treatment;
- Lost to follow-up after one treatment cycle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Retrospective Cohort Analysis of SMARCA4-Deficient Advanced Lung Cancer
This is a single-center retrospective analysis to explore the clinical characteristics, therapeutic efficacy, and tumor immune microenvironment of SMARCA4-deficient advanced non-small-cell lung cancer (NSCLC).
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SMARCA4-Deficient group | Not described | |
| SMARCA4-Intact group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from the beginning of first-line therapy to the first progression (PD) in patients with lung cancer
Measured: 5 years
Secondary outcomes (3)
Overall survival (OS)
Overall survival (OS) is defined as the duration from the beginning of first-line therapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Measured: 5 years
Objective Response Rate (ORR)
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: 5 years
Disease control rate (DCR)
Disease control rate (DCR) was defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Jan 2020
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SMARCA4-Deficient TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121387
- Sponsor's protocol ID
- L23(357)
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Retrospective Cohort Analysis of SMARCA4-Deficient Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07121387
- Acronym / sponsor ID
- L23(357)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 13 Aug 2025 (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 single-center retrospective analysis to explore the clinical characteristics, therapeutic efficacy, and tumor immune microenvironment of SMARCA4-deficient advanced non-small-cell lung cancer (NSCLC).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMARCA4-Deficient group | – | – |
| SMARCA4-Intact group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The clinical information of 221 patients with advanced non-small cell lung cancer from the Department of Oncology of Shanghai Pulmonary Hospital.
Key inclusion criteria (3 listed)
- Diagnosed with stage III-IV NSCLC according to the American Joint Committee on Cancer staging criteria (7th edition);
- Lesions are measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- Receiving first-line immunotherapy or chemotherapy as anti-tumor treatment.
Key exclusion criteria (3 listed)
- SMARCA4 gene test was not performed;
- Not receive treatment;
- Lost to follow-up after one treatment cycle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
Time frame: 5 years
Time from the beginning of first-line therapy to the first progression (PD) in patients with lung cancer
3 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Objective Response Rate (ORR)
Time frame: 5 years
Disease control rate (DCR)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SMARCA4-Deficient Tumor and NSCLC (Advanced Non-small Cell Lung Cancer), run by Shanghai Pulmonary Hospital, Shanghai, China 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 5 years). 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 13 Aug 2025.