RecruitingPhase 3NCT06711900

A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With 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 Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

432 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new antibody-drug conjugate (SKB264) combined with the immunotherapy pembrolizumab against standard chemotherapy plus pembrolizumab as a first treatment for a specific type of advanced lung cancer (non-squamous NSCLC) where tumors do not express PD-L1. **You may be eligible if...** - You have advanced non-squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV) not suitable for surgery or radiation - Your tumor has no PD-L1 expression (TPS less than 1%) - Your tumor does not have EGFR mutations, ALK fusions, or other driver mutations with approved targeted therapies - You have not had prior systemic treatment for advanced lung cancer - You are in good overall health (ECOG 0 or 1) **You may NOT be eligible if...** - Your tumor expresses PD-L1 - Your tumor has targetable genetic mutations (EGFR, ALK, ROS1, NTRK, BRAF, etc.) - You have received prior systemic therapy for your advanced lung cancer 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

IV Infusion

DRUGPembrolizumab

IV Infusion

DRUGpemetrexed

IV Infusion

DRUGcarboplatin or cisplatin

IV Infusion


Locations(1)

Shanghai Oriental Hospital

Shanghai, China

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NCT06711900


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