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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

NCT06598527 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

  • Lung Cancer (NSCLC)

Interventions

RADIATION

Stereotactic 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.

DRUG

Tislelizumab

PD-L1 inhibitor

DRUG

Chemotherapy

platinum-based double-agent chemotherapy

Sponsors & Collaborators

  • Yang Hong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2027-01-30
Completion
2030-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598527 on ClinicalTrials.gov