RecruitingPhase 3NCT06437977

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

Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: A Multicenter, Openlabel, Randomized, Phase III Trial


Sponsor

Shanghai Chest Hospital

Enrollment

478 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a pre-surgery treatment approach for early to locally advanced non-small cell lung cancer (NSCLC) that combines targeted radiation (SBRT) with immunotherapy (toripalimab) and chemotherapy before surgical removal, to try to shrink the tumor and improve cure rates. **You may be eligible if...** - You are between 18 and 75 years old - You have untreated, resectable (surgically removable) Stage II, IIIA, or IIIB (N2) NSCLC confirmed by biopsy - Your cancer does not have EGFR or ALK gene mutations - Your lung function is sufficient for surgery in your doctor's judgment - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer is locally advanced and cannot be surgically removed - You have NSCLC in the top of the lung (superior sulcus), large cell neuroendocrine carcinoma, or sarcomatoid tumors - Your cancer has EGFR or ALK mutations (other targeted therapies are more appropriate) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT

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

DRUGToripalimab

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

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NCT06437977


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