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

NCT ID: NCT07256509

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2032-06-30

Brief 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.

Detailed Description

This study includes three stages: a neoadjuvant therapy stage, a surgery stage, and an adjuvant follow-up stage. In the neoadjuvant therapy stage, eligible participants will be stratified by stage (Stage II and Stage III) and mutation type (19Del and L858R) and randomized in a 1:1 ratio to the SYS6010 combined with osimertinib treatment group and the osimertinib monotherapy group. Neoadjuvant therapy will be administered for 3 cycles.

In the surgery stage, the feasibility of surgery will be assessed by a thoracic surgery investigator. Surgery should be performed between Week 10 and Week 12 (i.e., D64-D84 after the first dose of neoadjuvant therapy). Tumor samples collected during surgery will be sent to a central pathology laboratory to assess pathological response.

In the adjuvant therapy stage, all participants who undergo surgery will subsequently enter the adjuvant therapy stage. Participants who do not undergo surgery for reasons other than disease progression will also enter the adjuvant therapy stage.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SYS6010 + Osimertinib

Neoadjuvant Therapy: SYS6010 + Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin

Group Type: EXPERIMENTAL

SYS6010

Intervention Type: DRUG

SYS6010 by intravenous (IV) infusion

Osimertinib

Intervention Type: DRUG

Osimertinib, oral

Osimertinib

Neoadjuvant Therapy: Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin

Group Type: ACTIVE_COMPARATOR

Osimertinib

Intervention Type: DRUG

Osimertinib, oral

Pemetrexed

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

AUC 5 mg/mL•min by IV infusion, Q3W

Interventions

SYS6010

SYS6010 by intravenous (IV) infusion

Intervention Type: DRUG

Osimertinib

Osimertinib, oral

Intervention Type: DRUG

Pemetrexed

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Carboplatin

AUC 5 mg/mL•min by IV infusion, Q3W

Intervention Type: DRUG

Other Intervention Names

Osimertinib Mesylate Tablets

Eligibility Criteria

Inclusion Criteria

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

2. Age 18-75 years, regardless of sex;

3. 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;

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

5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;

6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;

7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);

8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;

10. Life expectancy ≥6 months;

11. Adequate major organ and bone marrow function;

12. Women or men of childbearing potential must use highly effective contraception.

1. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. 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; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.

Exclusion Criteria

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

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

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

4. Eligible only for segmentectomy or wedge resection;

5. Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;

6. Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;

7. History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);

8. History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);

9. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;

10. Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);

11. Active or prior history of interstitial lung disease (ILD)/pneumonitis;

12. Expected to receive live vaccine therapy within 30 days after randomization;

13. History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;

14. Pregnant or lactating women;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Megalith Biopharmaceutical Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

+86-0311-69085587

Other Identifiers

SYS6010-013

Identifier Type: -

Identifier Source: org_study_id