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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Male or female, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF).

Histologically or cytologically confirmed NSCLC.

No prior systemic anti-tumor therapy.

No prior local therapy for NSCLC.

Disqualifiers

Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%.

Participants with other malignant tumors within 3 years prior to randomization.

Resting electrocardiogram (ECG) showing clinically significant abnormal results.

Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.

Trial design

Treatments tested in this trial

  • Sacituzumab Tirumotecan
  • Osimertinib

Treatment groups

60 Participants
are divided into 2 treatment groups