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RECRUITING
NCT05798845
PHASE2

The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

This randomized phase II trial is to explore the clinical efficacy, safety and feasibility of neoadjuvant immunotherapy plus radiotherapy compared with neoadjuvant immunotherapy plus chemotherapy in operable stage II-IIIA (N+) non small cell lung cancer (NSCLC) and the optimal radiotherapy pattern.

Official title: Exploratory Phase II Clinical Study of Toripalimab Plus Radiotherapy Versus Toripalimab Plus Chemotherapy for the Neoadjuvant Treatment of Operable Stage II-IIIA (N+) Non-small Cell Lung Cancer (NSCLC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-02-20

Completion Date

2026-12-31

Last Updated

2026-03-11

Healthy Volunteers

No

Conditions

Interventions

RADIATION

SBRT+LDRT

primary tumor SBRT, DT: 24Gy/3Fx, d1-3; positive lymph nodes LDRT, DT: 3Gy/3Fx, d1-3, d22-24 (2 cycles)

DRUG

Toripalimab

toripalimab 240mg ivgtt d4, d24 (2 cycles)

DRUG

Chemotherapy drug

Non-squamous carcinoma: pemetrexed + platinum or paclitaxel + platinum Squamous carcinoma: paclitaxel + platinum or gemcitabine + platinum

DRUG

Toripalimab

toripalimab 240mg ivgtt d1, d22 (2 cycles)

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China