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

NCT07329322 | Recruiting Phase 2

• 1 other identifier: SKB264-II-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR) rate

  MPR rate is defined as the proportion of participants achieving ≤ 10% residual viable tumor cells in the postoperative surgical specimen.

  up to 60 months

Secondary Outcomes (13)

• pathological Complete Response (pCR) rate

  up to 60 months

• Residual viable tumor percentage (RVT%)

  up to 60 months

• R0 resection rate

  up to 60 months

• Pathological lymph node downstaging rate

  up to 60 months

• Pathological primary tumor downstaging rate

  up to 60 months

Study Arms (2)

Sacituzumab Tirumotecan+Osimertinib

EXPERIMENTAL

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

Drug: Sacituzumab Tirumotecan; Drug: Osimertinib

Sacituzumab Tirumotecan

EXPERIMENTAL

Participants will receive Sacituzumab Tirumotecan for each 2-week cycle

Drug: Sacituzumab Tirumotecan

Interventions

Sacituzumab Tirumotecan DRUG

Sacituzumab Tirumotecan: 4mg/kg, intravenous (IV) infusion

Sacituzumab Tirumotecan; Sacituzumab Tirumotecan+Osimertinib

Osimertinib DRUG

80mg, QD

Sacituzumab Tirumotecan+Osimertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• At least one target lesion as assessed by the investigator according to RECIST v1.1.
• Life expectancy ≥ 24 weeks.
• Adequate organ and bone marrow function.
• For female participants of childbearing potential and male participants with partners of childbearing potential, they must agree to use effective medical contraception from the start of signing the ICF until 6 months after the last dose.
• Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures.

You may not qualify if:

• 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.
• Uncontrolled systemic diseases in the investigator's judgment.
• History of interstitial lung disease (ILD), drug-induced ILD, or non-infectious pneumonitis, have current ILD or non-infectious pneumonitis.
• Clinically severe lung damage due to complications of lung disorder.
• Participants who have received systemic corticosteroids therapy with \> 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before randomization.
• Known active pulmonary tuberculosis.
• Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.
• Active hepatitis B.
• Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Known hypersensitivity to osimertinib, sacituzumab tirumotecan, or any of their components (including but not limited to polysorbate-20); known history of severe hypersensitivity to other biologics.
• Have received a live vaccine within 30 days prior to randomization, or plan to receive a live vaccine during the study.
• Pregnant or lactating women.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yina Diao

CONTACT

028-67252634; diaoyina@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 9, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2032
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CN (1)