A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT06670196
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • SKB264 — DRUG
    4mg/kg, intravenous (IV) infusion
  • Osimertinib — DRUG
    80mg, QD

Study Details

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.

Key Dates

Start date
Nov 27, 2024
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: SKB264+Osimertinib
    Participants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle, Osimertinib once-daily for each 4-week cycle.
  • Active Comparator: Osimertinib
    Participants will receive Osimertinib once-daily for each 4-week cycle.

Primary Outcome Measure

Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) [ Time Frame: Randomization up to approximately 36 months ]

Central Contacts

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