Efficacy and Safety Study of Anlotinib With Pembrolizumab in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Non-small Cell Lung Cancer

  • participants needed
  • sponsor
    Peking Union Medical College Hospital
Updated on 7 December 2022
systemic therapy
progressive disease
cancer chemotherapy
solid tumour
recurrent non-small cell lung cancer
lung carcinoma
secondary malignant neoplasm of liver
proto-oncogene tyrosine-protein kinase ros


The purpose of this study is to assess the safety and efficacy of Anlotinib (AL3818) combined with pembrolizumab (MK-3475) in treatment-nave adults with no prior systemic therapy for advanced non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses is that the combination of Anlotinib and pembrolizumab is superior to pembrolizumab alone(historical data) as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Condition NSCLC
Treatment Pembrolizumab, Anlotinib, oral capsule
Clinical Study IdentifierNCT04164745
SponsorPeking Union Medical College Hospital
Last Modified on7 December 2022

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