Trials / Terminated
TerminatedNCT05001724
KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent
A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Compare Efficacy, Safety, and Tolerability of KN046 Combined With Lenvatinib Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer After Failure of Anti-PD-(L)1 Agent
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | KN046 | KN046 is 5 milligram per kilogram, every 3 weeks. |
| DRUG | Lenvatinib | Lenvatinib is RP3D milligram per day, every day. |
| DRUG | Docetaxel | Docetaxel is 75 milligram per Square meter, every 3 weeks. |
Timeline
- Start date
- 2021-10-28
- Primary completion
- 2023-02-13
- Completion
- 2023-04-07
- First posted
- 2021-08-12
- Last updated
- 2023-04-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05001724. Inclusion in this directory is not an endorsement.