RecruitingPhase 2NCT05798845

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

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)


Sponsor

Shanghai Chest Hospital

Enrollment

124 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (toripalimab) to radiation therapy before surgery can improve outcomes in patients with operable stage II–IIIA non-small cell lung cancer (NSCLC) — lung cancer that has not yet spread to distant organs. **You may be eligible if...** - You are between 18 and 75 years old - You have non-small cell lung cancer confirmed by pathology - Your cancer is at stage II–IIIA (specifically T1-2N1-2M0 or T3N1M0) - No distant spread has been found on CT or PET/CT scans - Your tumor does not have EGFR, ALK, or ROS1 mutations (specific genetic markers) - You are physically fit for lung surgery **You may NOT be eligible if...** - You have known driver gene mutations (EGFR, ALK, ROS1) - Your cancer has spread outside the chest - You have inadequate organ function 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+LDRT

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

DRUGToripalimab

toripalimab 240mg ivgtt d4, d24 (2 cycles)

DRUGChemotherapy drug

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

DRUGToripalimab

toripalimab 240mg ivgtt d1, d22 (2 cycles)


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT05798845


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