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A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)

NCT04325763 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2022-03-31

No results posted yet for this study

Summary

This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Conditions

  • Stage III Non-small-cell Lung Cancer

Interventions

DRUG

TQB2450

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

DRUG

Anlotinib

a multi-target receptor tyrosine kinase inhibitor

DRUG

TQB2450(blank)

Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

DRUG

Anlotinib(blank)

Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

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
2020-05-27
Primary Completion
2022-12-31
Completion
2025-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04325763 on ClinicalTrials.gov