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

NCT05429463 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-12-14

No results posted yet for this study

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.

Conditions

  • Squamous Cell Non-small Cell Lung Cancer

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2025-11-11
Completion
2029-11-11

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429463 on ClinicalTrials.gov