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 | Not Yet Recruiting Phase 2

• 1 other identifier: SYS6010-013
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (9)

• Major Pathological Response (MPR) Rate

  Defined as the proportion of participants with ≤10% residual viable tumor cells in the resected primary tumor bed, as assessed by blinded independent pathological review (BIPR).

  Within 8 weeks post-surgery

• Pathological Complete Response (pCR) Rate

  The proportion of participants with no residual viable tumor cells in both the resected primary tumor bed and lymph nodes, as assessed by BIPR.

  Within 8 weeks post-surgery

• Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery

  Within 8 weeks post-surgery

• Disease-Free Survival (DFS)

  Investigator-assessed DFS per RECIST v1.1

  Up to approximately 5.5 years after the last participant enrolled

• Event-Free Survival (EFS)

  Investigator-assessed DFS per RECIST v1.1

  Up to approximately 5.5 years after the last participant enrolled

• Objective Response Rate (ORR)

  Investigator-assessed ORR per RECIST v1.1

  Up to approximately 5.5 years after the last participant enrolled

• Overall Survival (OS)

  Up to approximately 5.5 years after the last participant enrolled

• Incidence of Adverse Events (AEs)

  Up to approximately 5.5 years after the last participant enrolled

• Anti-drug Antibodies (ADAs) to SYS6010

  Up to approximately 5.5 years after the last participant enrolled

Study Arms (2)

SYS6010 + Osimertinib

EXPERIMENTAL

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

Drug: SYS6010; Drug: Osimertinib

Osimertinib

ACTIVE COMPARATOR

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

Drug: Osimertinib; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

SYS6010 DRUG

SYS6010 by intravenous (IV) infusion

SYS6010 + Osimertinib

Osimertinib DRUG

Osimertinib, oral

Also known as: Osimertinib Mesylate Tablets

Osimertinib; SYS6010 + Osimertinib

Pemetrexed DRUG

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

Osimertinib

Cisplatin DRUG

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

Osimertinib

Carboplatin DRUG

AUC 5 mg/mL•min by IV infusion, Q3W

Osimertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;
• 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;
• No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);
• At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Life expectancy ≥6 months;
• Adequate major organ and bone marrow function;
• Women or men of childbearing potential must use highly effective contraception.
• \. 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.

You may not qualify if:

• Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;
• 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;
• Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;
• Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;
• History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);
• History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);
• Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
• Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);
• Active or prior history of interstitial lung disease (ILD)/pneumonitis;
• Expected to receive live vaccine therapy within 30 days after randomization;
• History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;
• Pregnant or lactating women;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

+86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Open-label, Phase II

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): June 30, 2032
• Last Updated: December 5, 2025

Record last verified: 2025-11