RecruitingPhase 3NCT05429463

Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC(neoSCORE Ⅱ)

Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC(neoSCORE Ⅱ):A Prospective, Randomized, Open-Label, Multi-Center Phase 3 Trial


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

250 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Summary

This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (neoSCORE II) is testing whether adding sintilimab (an immunotherapy drug) to standard chemotherapy before surgery improves outcomes for people with resectable squamous cell non-small cell lung cancer (NSCLC) — a specific type of lung cancer — allowing more people to successfully undergo surgery after shrinking the tumor first. **You may be eligible if:** - You are between 18 and 75 years old - You have squamous cell NSCLC confirmed by biopsy - Your cancer has not been treated before and is classified as resectable Stage IIA–IIIB - Your general health is good (ECOG 0–1) - Your life expectancy is more than 6 months - Your blood counts, liver, kidney, and thyroid function are within acceptable ranges **You may NOT be eligible if:** - You have non-squamous NSCLC (e.g., adenocarcinoma) - You have previously received any treatment for this cancer - You have severe organ dysfunction - You are pregnant or breastfeeding 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

BIOLOGICALSintilimab

200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

DRUGCarboplatin

AUC 5-6 mg/mL/min by IV infusion Q3W, given on cycle day 1.

DRUGAlbumin-Bound Paclitaxel

260 mg/m\^2 by IV infusion Q3W, given on cycle day 1.


Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT05429463