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RECRUITING
NCT06711900
PHASE3

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

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

432

Start Date

2024-10-30

Completion Date

2028-12

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

SKB264

IV Infusion

DRUG

Pembrolizumab

IV Infusion

DRUG

pemetrexed

IV Infusion

DRUG

carboplatin or cisplatin

IV Infusion

Locations (1)

Shanghai Oriental Hospital

Shanghai, China