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NOT YET RECRUITING
NCT07256509
PHASE2

A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.

Official title: A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-30

Completion Date

2032-06-30

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DRUG

SYS6010

SYS6010 by intravenous (IV) infusion

DRUG

Osimertinib

Osimertinib, oral

DRUG

Pemetrexed

500 mg/m\^2 by IV infusion, Q3W

DRUG

Cisplatin

75 mg/m\^2 by IV infusion, Q3W

DRUG

Carboplatin

AUC 5 mg/mL•min by IV infusion, Q3W