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Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)

NCT03358875 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2025-02-10

Study results available
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Summary

The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.

Conditions

Interventions

DRUG

Tislelizumab

Tislelizumab administered by intravenous (IV) infusion

DRUG

Docetaxel

Docetaxel administered as an IV infusion over 1 hour

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2021-07-15
Completion
2024-01-18

Countries

  • Brazil
  • Bulgaria
  • China
  • Lithuania
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • Slovakia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03358875 on ClinicalTrials.gov