Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07329322
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.

Key Dates

Start date
Mar 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Oct 31, 2032

Study Design

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

Arms

  • Experimental: Sacituzumab Tirumotecan+Osimertinib
    Participants will receive Sacituzumab Tirumotecan for each 2-week cycle, Osimertinib once-daily for each 2-week cycle.
  • Experimental: Sacituzumab Tirumotecan
    Participants will receive Sacituzumab Tirumotecan for each 2-week cycle

Primary Outcome Measure

Major Pathological Response (MPR) rate [ Time Frame: up to 60 months ]

Central Contacts

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