NCT07121387

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

August 6, 2025

Last Update Submit

August 6, 2025

Conditions

SMARCA4-Deficient TumorNSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

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

    5 years

Secondary Outcomes (3)

  • Overall survival (OS)

    5 years

  • Objective Response Rate (ORR)

    5 years

  • Disease control rate (DCR)

    5 years

Other Outcomes (1)

  • The correlation between tumor immune microenvironment and therapeutic efficacy

    5 years

Study Arms (2)

SMARCA4-Deficient group

SMARCA4-Intact group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 13, 2025

Study Start

January 1, 2020

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)