CI

At a glance

ClinicalIndex Comparison Record
Phase 3Terminated· 16 enrolled
Drug / intervention
KN046 +2 morebiological
Likely dose
KN046 5 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05001724
NCT05001724Phase 3Terminated
Terminated

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

Jiangsu Alphamab Biopharmaceuticals Co., Ltd·interventional·Posted Aug 12, 2021·Updated Apr 25, 2023

In Brief

A Phase 3 clinical trial evaluating KN046, Lenvatinib, and 1 other intervention for Advanced Non-small Cell Lung Cancer. Terminated early, enrolled 16 participants across 1 site.

Signals

Trial was terminated early

Detailed 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3TerminatedFinished
20222023202420252026
First PostedAug 12, 2021
Enrollment StartOct 28, 2021
Primary CompletionFeb 13, 2023
Study CompletionApr 7, 2023
TodayJul 1, 2026
Enrollment to primary: 1.3 yearsPosted 4.9 years ago

Interventions

KN046biological

KN046 is 5 milligram per kilogram, every 3 weeks.

Lenvatinibdrug

Lenvatinib is RP3D milligram per day, every day.

Docetaxeldrug

Docetaxel is 75 milligram per Square meter, every 3 weeks.