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

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

October 15, 2024

Primary Completion Date

January 30, 2027

Study Completion Date

January 30, 2030

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

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Yang Hong

OTHER