RecruitingPhase 3NCT06598527

Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study


Sponsor

Yang Hong

Enrollment

360 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are: Dose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough? Participants will: Receive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy. Tumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Chinese study is testing whether adding targeted radiation therapy (SBRT) before immunotherapy and chemotherapy improves outcomes compared to immunotherapy and chemotherapy alone as a pre-surgery treatment for patients with resectable stage II-III non-small cell lung cancer (NSCLC). **You may be eligible if...** - You have confirmed non-small cell lung cancer, stage IIa to IIIa (or potentially resectable IIIb) - Your tumor has been evaluated as removable by a surgical team - You are between 18 and 75 years old - You have good performance status (ECOG 0-1) - Your blood counts and organ function meet study requirements **You may NOT be eligible if...** - You have an autoimmune disease (with some exceptions) - You need systemic corticosteroids at high doses - You have had prior chest radiotherapy - Your NSCLC has EGFR mutation or ALK fusion (different targeted treatments are available) - You have active hepatitis B or C, or HIV - 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

RADIATIONStereotactic body radiotherapy (SBRT)

Radiation source: 6MV photon linear gas pedal is used. Position immobilization: supine position, hands up, vacuum bag or styrofoam immobilization. Radiotherapy plan design: 4DCT positioning, radiotherapy plan design at 20% respiratory time-phase CT, isocentric irradiation, IMRT or VMAT design. Definition of target area: Gross tumor volume (GTV) includes the primary tumor in the lung, excluding lymph nodes. Internal target volume (ITV); Internal target volume (ITV) is formed by the fusion of 10 respiratory phases of GTV; Planning target volume (PTV) is formed by expanding the ITV by 0.5 cm in all directions.

DRUGTislelizumab

PD-L1 inhibitor

DRUGChemotherapy

platinum-based double-agent chemotherapy


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06598527


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