RecruitingPhase 3NCT06670196

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

A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for 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.

Enrollment

420 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a new drug called SKB264 (an antibody-drug conjugate that targets TROP2) with osimertinib (a standard EGFR-targeted therapy) works better than osimertinib alone as a first-line treatment for people with advanced non-squamous non-small cell lung cancer that has a sensitive EGFR mutation. **You may be eligible if...** - You are 18–75 years old with advanced or metastatic non-squamous NSCLC - Your tumor has a confirmed EGFR-sensitive mutation - You have not received any prior systemic treatment for advanced NSCLC - You are in good health (ECOG 0–1) with adequate organ function and a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have received prior EGFR therapy, TROP2-targeted therapy, or topoisomerase I inhibitors - You have active or symptomatic brain metastases, spinal cord compression, or meningeal involvement - You have interstitial lung disease, heart disease, or significant cardiovascular risk factors - You have had another cancer within 3 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB264

4mg/kg, intravenous (IV) infusion

DRUGOsimertinib

80mg, QD


Locations(2)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06670196


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