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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Able to understand and voluntarily sign the written informed consent form (ICF);

Age 18-75 years, regardless of sex;

Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;

Must be eligible for complete surgical resection of the primary tumor;

Disqualifiers

Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;

Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;

T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and/or bulky N2 disease;

Eligible only for segmentectomy or wedge resection;

Trial design

Treatments tested in this trial

  • SYS6010
  • Osimertinib
  • Pemetrexed
  • Cisplatin
  • Carboplatin

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations