RecruitingPhase 2NCT06586697

First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy

Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy:a Phase II, Single Arm, Prospective Trial


Sponsor

Henan Cancer Hospital

Enrollment

47 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted chest radiation therapy after chemotherapy plus immunotherapy can further improve outcomes in patients with extensive-stage small cell lung cancer (SCLC) — an aggressive form of lung cancer — who have not progressed on their initial treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed extensive-stage small cell lung cancer (SCLC) - You have completed 4–6 cycles of chemotherapy combined with a PD-1 or PD-L1 immunotherapy drug and have not progressed - You have at least one measurable lung tumor on imaging - Your overall health is rated 0–1 on standard performance scales **You may NOT be eligible if...** - You have progressed on your initial chemotherapy + immunotherapy treatment - You have previously had chest radiation - You have active brain metastases - You have serious heart or lung conditions that would make radiation unsafe - You are pregnant or breastfeeding 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

RADIATIONThoracic Radiotherapy

Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)


Locations(1)

HenanCH

Zhengzhou, Henan, China

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NCT06586697


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