A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07376382
Phase
PHASE3
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，intravenous injection
  • Osimertinib — DRUG
    Osimertinib 80mg P.O. QD
  • platinum-pemetrexed — DRUG
    Pemetrexed (500 mg/m\^2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m\^2) every 3 weeks. Pemetrexed (500 mg/m\^2) plus cisplatin (75 mg/m\^2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m\^2) every 3 weeks.

Study Details

This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups: Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 12, 2026
Completion
Jun 6, 2029

Study Design

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

Arms

  • Experimental: SYS6010 combination
    SYS6010 + Osimertinib
  • Active Comparator: Investigator's Choice of treatment
    Investigator's choice of treatment means the treatment chosen by investigators to treat NSCLC including Osimertinib or Osimertinib plus platinum-pemetrexed Osimertin.ib

Primary Outcome Measure

Progression Free Survival(PFS) evaluated by IRC [ Time Frame: Up to 3.5 years ]

Central Contacts

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