RecruitingPhase 2NCT05837052

A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC

A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer


Sponsor

Zhejiang University

Enrollment

49 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding serplulimab (an immunotherapy drug) to chemotherapy as a "conversion" therapy can shrink tumors enough in patients with advanced non-small cell lung cancer (NSCLC) that surgery becomes possible. The idea is to give this combination first, and if the tumors respond well enough, follow with surgery to try for a cure. **You may be eligible if...** - You are between 18 and 75 years old with confirmed non-small cell lung cancer - Your cancer is at an advanced stage (stage IIIB–IVA with limited spread — "oligometastatic") - You have not yet received any treatment for your lung cancer - After treatment, surgical removal of the main tumor should be feasible - Your overall health is good (ECOG score 0–1) and lung function is sufficient for surgery **You may NOT be eligible if...** - You have already received any cancer treatment - Your disease is too widely spread to potentially be operable even with response to treatment - You have certain genetic mutations that are better treated with targeted therapy first Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREserplulimab plus chemotherapy as conversion treatment

Patients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions.


Locations(1)

Zhejiang University

Hangzhou, Zhejiang, China

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NCT05837052


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