RecruitingPhase 2NCT06849167

Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLC

A Single-Arm Phase II Clinical Trial of Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

63 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Summary

Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy. Participants will undergo large fractionated radiotherapy with a total dose of 48Gy/16 fractions, 3Gy per fraction, 5 days a week. Participants will receive two cycles of concurrent platinum-based doublet chemotherapy and concurrent immunotherapy. Patients without progression will receive consolidation immunotherapy. The maximum duration of immunotherapy is 24 months.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining immunotherapy (a drug that helps the immune system attack cancer) with a condensed course of radiation and chemotherapy given at the same time, followed by continued immunotherapy, improves outcomes for patients with locally advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery. **You may be eligible if...** - You are between 18 and 70 years old - You have been confirmed by biopsy or cytology to have inoperable locally advanced NSCLC (stage IIB–IIIC) - Your cancer has not spread to distant organs - Your general health is adequate and you have lost less than 10% of your body weight recently - Your lung, heart, liver, and kidney function are sufficient to tolerate treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IV) - You have an active autoimmune disease or are on long-term steroids - You have had prior chemotherapy or radiation to the chest - You are pregnant or breastfeeding - You have serious heart or liver disease 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

RADIATIONhypofractionated radiotherapy with immunotherapy

Immunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy


Locations(1)

Peking University Cancer Hospital & Institute

Beijing, China

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NCT06849167