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NCT Number: NCT07121387

A Retrospective Cohort Analysis of SMARCA4-Deficient 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).

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Key information

Conditions

SMARCA4-Deficient Tumor Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC (Advanced Non-small Cell Lung Cancer) Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Pulmonary Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    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.

  2. Objective Response Rate (ORR)

    Time frame: 5 years

    The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  3. Disease control rate (DCR)

    Time frame: 5 years

    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).

Other outcomes

  1. The correlation between tumor immune microenvironment and therapeutic efficacy

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

A Real-World Retrospective Cohort Analysis of SMARCA4-Deficient Advanced Lung Cancer

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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