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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

NCT07256509 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

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
2025-11-30
Primary Completion
2026-11-30
Completion
2032-06-30

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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 NCT07256509 on ClinicalTrials.gov