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KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer

NCT04474119 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2021-11-24

No results posted yet for this study

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.

Conditions

  • Squamous Non-small-cell Lung Cancer

Interventions

DRUG

KN046

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.

DRUG

KN046 placebo

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.

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou, MD, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2022-08-30
Completion
2023-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474119 on ClinicalTrials.gov