deltatrials
Recruiting INTERVENTIONAL NCT07329322

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

A Randomized, Open-label, Multicenter, Phase II Clinical 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

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Conditions Non-Small Cell Lung Cancer
Interventions Osimertinib Sacituzumab Tirumotecan
Updated 2 times since 2026 Last updated: Apr 27, 2026 Started: Mar 30, 2026 Primary completion: Aug 31, 2027 Completion: Oct 31, 2032
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Non-Small Cell Lung Cancer, this trial is actively recruiting participants. The trial is conducted by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and has accumulated 2 data snapshots since 2026. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

This is a randomized, open-label, multicenter, Phase 2 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.

This is a randomized, open-label, multicenter, Phase 2 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.

Status Flow

~Feb 2026 – ~May 2026 · 3 months · monthly snapshotNot Yet RecruitingMay 4, 2026 – present · 4 months · daily APIRecruiting

Change History

2 versions recorded

  1. May 4, 2026 — Present [daily]

    Recruiting

    Status: Not Yet Recruiting → Recruiting · Phase: PHASE2 → None

  2. Feb 2026 — May 2026 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations