drugset / Trial / NCT05001724

KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent

NCT05001724

Phase 2/3 Terminated 16 enrolled Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio. Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day. Control group: Docetaxel 75mg/m2 Q3W .

Timeline

Start
2021-10-28
Primary completion
2023-02-13
Completion
2023-04-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2
Subject ERFONRILIMAB Monoclonal antibody 5 mg/kg
Subject Lenvatinib Small molecule