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A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer

A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non-small Cell Lung Cancer

NCT03594747•BeiGene

View on ClinicalTrials.gov

Summary

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-75 years old, male or female, and signed informed consent form (ICF)
•2. Advanced NSCLC diagnosed by pathological or clinical physicians
•3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
•4. Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
•5. Must be treatment-naive for locally advanced or metastatic squamous NSCLC
•6. Life expectancy ≥ 12 weeks
•7. Participants must have adequate organ function
•8. Male/Female is willing to use a highly effective method of birth control

Exclusion Criteria

•1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
•2. Received any approved systemic anticancer therapy
•3. Received prior treatment with EGFR inhibitors or ALK inhibitors
•4. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
•5. With history of interstitial lung disease
•6. Clinically significant pericardial effusion
•7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
•8. Any major surgical procedure before randomization
•9. Human immunodeficiency virus infection
•10. Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
+2 more criteria

Locations (43)

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences