NCT04234607

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)

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 738 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-01-21
• Last updated: 2020-01-22

Locations

26 sites across 1 country: China