Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05429463
PHASE3

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2022-11-11

Completion Date

2029-11-11

Last Updated

2022-12-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sintilimab

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

DRUG

Carboplatin

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

DRUG

Albumin-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