drugset / Trial / NCT05001724
KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | ERFONRILIMAB | Monoclonal antibody | 5 mg/kg | — |
| Subject | Lenvatinib | Small molecule | — | — |