Efficacy and Safety Analysis of First-Line ABCP Therapy in Advanced SMARCA4-Mutated NSCLC

Launched by FUZHOU GENERAL HOSPITAL · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment called ABCP for people with advanced non-small cell lung cancer (NSCLC) who have a specific genetic change called a SMARCA4 mutation. This mutation is linked to a more aggressive form of lung cancer that doesn’t respond well to standard treatments and usually has a shorter survival time. The ABCP treatment combines four medicines that work together to help the immune system fight cancer and directly attack the tumor. Researchers want to see if this treatment is safe and more effective for patients with this mutation.

People who might be eligible for this study are adults with advanced or recurrent non-squamous NSCLC that cannot be treated with surgery or radiation, who have the SMARCA4 mutation confirmed by genetic testing, and who have not received any previous cancer treatment. Participants need to be generally healthy enough to take part (with a good performance status) and should not have certain conditions like active autoimmune diseases or bleeding problems. If accepted, patients will receive the ABCP treatment and be closely monitored to track how well it works and to check for any side effects. The study is currently not recruiting yet, but it aims to help find better treatment options for this hard-to-treat type of lung cancer.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with pathologically confirmed NSCLC, meeting the following criteria based on the IASLC 9th Edition Lung Cancer TNM Staging System (International Association for the Study of Lung Cancer/Union for International Cancer Control): Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC) disease not amenable to curative-intent concurrent chemoradiotherapy, metastatic, or recurrent (Stage IV) non-squamous NSCLC;
• • 2. Confirmed SMARCA4 mutation (verified by NGS testing);
• • 3. ECOG performance status 0-1, with no prior systemic anticancer therapy;
• • 4. Absence of driver gene mutations (e.g., EGFR, ALK, ROS1);
• • 5. Patients capable of providing sufficient blood samples (detailed in sample requirements) and complete baseline clinical data, including: age, gender, smoking history, family history, lesion location(s), lesion size(s), number of lesions, tumor markers, pathological indicators, treatment records, and re-examination/follow-up information;
• • 6. Voluntary participation with signed informed consent form, willingness to undergo follow-up assessments and provide treatment process details, efficacy data, and prognostic information, with commitment to complete the entire study.
• Exclusion Criteria:
• • (1) Active autoimmune diseases or interstitial lung disease; (2) Bleeding tendency or contraindications to Bevacizumab.