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Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

NCT05116462 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2025-06-26

No results posted yet for this study

Summary

This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

Conditions

Interventions

DRUG

Pemetrexed

500 mg/m2 D1 IV Q3W

DRUG

Carboplatin

AUC 5 or 6 mg/ml/min D1 IV Q3W

DRUG

Paclitaxel

175 or 200 mg/m2 D1 IV Q3W

DRUG

Sintilimab

200 mg D1 IV Q3W

DRUG

Cisplatin

75 mg/m2 D1 IV Q3W

DRUG

Nab paclitaxel

100 mg/m2 D1, 8, 15 IV Q3W

DRUG

Placebo

20 ml D1 IV Q3W

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2026-09-30
Completion
2028-10-14

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05116462 on ClinicalTrials.gov