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ACTIVE NOT RECRUITING
NCT05870319
PHASE3

A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

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

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Official title: A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

376

Start Date

2023-06-26

Completion Date

2026-09-30

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DRUG

SKB264

intravenous (IV) infusion (Q2W)

DRUG

Pemetrexed

500 mg/m2 intravenous (IV) infusion (Q3W)

DRUG

Carboplatin

AUC 5 intravenous (IV) infusion (Q3W) 4cycles

DRUG

Cisplatin

75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China