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CompletedNCT07121387Updated Aug 13, 2025

A Retrospective Cohort Analysis of SMARCA4-Deficient Lung Cancer

An observational study in SMARCA4-Deficient Tumor and NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
221
Sex
All
01

Study 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).

02

Conditions studied

  • SMARCA4-Deficient Tumor
  • NSCLC (Advanced Non-small Cell Lung Cancer)
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 221 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The clinical information of 221 patients with advanced non-small cell lung cancer from the Department of Oncology of Shanghai Pulmonary Hospital.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • SMARCA4 gene test was not performed;
  • Not receive treatment;
  • Lost to follow-up after one treatment cycle.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
221 participants (actual)
Patient registry
No

Groups and cohorts

  • SMARCA4-Deficient group
  • SMARCA4-Intact group
06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    Time from the beginning of first-line therapy to the first progression (PD) in patients with lung cancer

    Time frame: 5 years

Secondary outcomes

  1. 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.

    Time frame: 5 years

  2. 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)

    Time frame: 5 years

  3. 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).

    Time frame: 5 years

Other outcomes

  1. The correlation between tumor immune microenvironment and therapeutic efficacy

    Multiplex immunofluorescence staining was performed on pathological specimens from individuals diagnosed with SMARCA4-deficient lung cancer who underwent immune combination chemotherapy.

    Time frame: 5 years

07

Study locations

1 site
  • Shanghai Pulmonary Hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07121387
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Responsible party
Yayi He (Professor, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Aug 13, 2025
Start date
Jan 1, 2020
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024
Last update
Aug 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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