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A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701)

NCT04234607 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 738

Last updated 2020-01-22

No results posted yet for this study

Summary

A randomized, double-blind, controlled, multicenter phase III study of TQB2450 or placebo combined with Anlotinib, etoposide and carboplatin versus Etoposide and Carboplatin in subjects with extensive small cell lung cancer. The primary outcome measures include PFS and OS. Extended stage Small Cell Lung Cancer (SCLC) patients will be registered, after signing the informed consent, and then centrally randomized 1:1:1 to the experimental arms and the control arm.

Conditions

  • Extensive 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

Etoposide

Etoposide is a cell cycle-specific antitumor drug

DRUG

Carboplatin

Carboplatin is cell cycle nonspecific antitumor drug

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
2020-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

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 NCT04234607 on ClinicalTrials.gov