Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients
Condition: NSCLC Stage IV
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      Pembrolizumab is approved for advanced stage non-small cell lung cancer. However, the
      response rate is low (around 10-15 %) in patients treated in Macau SAR, China. The
      investigators hypothesize CD38 expressing cells and/or other immune populations will help to
      predict response.
    

Detailed description: 
      Lung cancer is the leading cause of cancer death, the overall survival rate is low. Recently,
      using anti-PD-L1 immunotherapy for treatment of cancer shows promising in some types of
      cancer, including melanoma, head and neck squamous cell cancer, and lung cancer etc.
      Pembrolizumab is a FDA-approved anti-PD-L1 drug for treatment of advanced stage non-small
      cell lung cancer. In China, it is approved for used in Macau and Hong Kong. Biomarkers
      associated with predictive response includes PD-L1 high expression, high mutational burden,
      and T-cell infiltration based on several clinical trial studies in the western countries.
      However, the response rate is low (around 10-15 %) in patients treated in Macau SAR, China.
      The investigators hypothesize that immunophenotying, molecular analysis and functional
      characterization of CD38 expressing cells and/or other immune populations CD38 will help to
      identify predictive, Progression and resistance markers associated with PDL1 treatment
      response. The investigators will collect the blood samples of Pembrolizumab response and
      non-response Chinese lung cancer patients and compare the imumnophenotypic and molecular
      dynamic changes during treatment courses. The investigators will also examine the role of
      CD38 and other molecular markers associated with Pembrolizumab response, functional
      characterize in vitro. The molecular mechanism controlling Pembrolizumab response will be
      better understood for designing a better treatment strategy.
    

Intervention name(s): Pembrolizumab
Intervention type(s): Drug
Intervention description(s): pembrolizumab is a PD-1 inhibitor. Treatment and follow up will be performed at Kiang Wu Hospital in their clinical oncology center. Clinically pathological related information will be recorded.
Intervention MeSH terms: Pembrolizumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study cohort will include locally advanced or metastatic NSCLC patients with PD-L1
        status available and receive pembrolizumab treatment per the judgement of treating
        physicians in the participating site in Macau. 30-40 patients are anticipated to be
        enrolled in the study, the majority of which are estimated to be from mainland China.
      
Biospecimen description: 
      7 ml of whole blood from patients and donor will be collected. Blood samples will be stored
      in EDTA-coating tube. PBMC will be isolated using a density gradient technique. Whole blood
      will be processed using standard protocol.
    
Keywords: NSCLC; PD-L1; Biomarkers