drugset / Trial / NCT05294172

KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

NCT05294172

Phase 3 Active not recruiting 295 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

Timeline

Start
2022-06-07
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject KL-A167 Unknown 1200 mg
Background Cisplatin Other / unclassified 80 mg/m2
Background Gemcitabine Small molecule 1000 mg/m2