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

NCT05798845 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-03-11

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Shanghai Chest Hospital

    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
2025-02-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05798845 on ClinicalTrials.gov