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RECRUITING
NCT06437977
PHASE3

Neoadjuvant Therapy of SBRT Sequencial with Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC.

Official title: Neoadjuvant Therapy of SBRT Sequencial with Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: a Multicenter, Openlabel, Randomized, Phase III Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

478

Start Date

2024-09-12

Completion Date

2029-06

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

RADIATION

SBRT

SBRT. 24Gy/3fractions Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W

DRUG

Toripalimab

Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W

Locations (1)

Shanghai Chest Hospital

Shanghai, China