CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 482 enrolled
Drug / intervention
KN046 +1 moredrug
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/NCT04474119
NCT04474119Phase 3Unknown

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Platinum-containing Chemotherapy Versus Placebo Combined With Platinum-containing Chemotherapy in First Line Advanced Squamous Non-small Cell Lung Cancer Subjects (ENREACH-L-01)

Jiangsu Alphamab Biopharmaceuticals Co., Ltd·interventional·Posted Jul 16, 2020·Updated Nov 24, 2021

In Brief

A Phase 3 clinical trial evaluating KN046 and KN046 placebo for Squamous Non-small-cell Lung Cancer. Targeting 482 participants across 1 site.

Detailed Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment.

Study Details

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

Timeline

Phase 3UnknownOverdue
202120222023202420252026
First PostedJul 16, 2020
Enrollment StartSep 14, 2020
Primary CompletionAug 30, 2022
Study CompletionAug 30, 2023
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 6.0 years ago

Interventions

KN046drug

In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.

KN046 placebodrug

In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks.