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NOT YET RECRUITING
NCT07854509
PHASE2

A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure

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

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. The study includes a dose escalation phase and an expansion phase.

Official title: A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer in Participants Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-10-15

Completion Date

2029-12-30

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

SKB264+SKB118

Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.