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ACTIVE NOT RECRUITING
NCT05116462
PHASE3

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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).

Official title: A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

506

Start Date

2024-03-15

Completion Date

2028-10-14

Last Updated

2025-06-26

Healthy Volunteers

No

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

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China