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.
Study ID
NCT07256509
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYS6010 — DRUG
    SYS6010 by intravenous (IV) infusion
  • Osimertinib — DRUG
    Osimertinib, oral
  • Pemetrexed — DRUG
    500 mg/m\^2 by IV infusion, Q3W
  • Cisplatin — DRUG
    75 mg/m\^2 by IV infusion, Q3W
  • Carboplatin — DRUG
    AUC 5 mg/mL•min by IV infusion, Q3W

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Jun 30, 2032

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6010 + Osimertinib
    Neoadjuvant Therapy: SYS6010 + Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin
  • Active Comparator: Osimertinib
    Neoadjuvant Therapy: Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin

Primary Outcome Measure

Major Pathological Response (MPR) Rate [ Time Frame: Within 8 weeks post-surgery ]

Central Contacts

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