This is a phase II trial of durvalumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection (cohort 1) or hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (cohort 2) will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. We hypothesized that Durvalumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV, HBV, or HCV infection.
Name: Durvalumab
Description: Incidence of treatment-emergent Adverse Events according to NCI CTCAE v5.0.
Measure: Adverse Events Time: At the end of Cycle 4 (each cycle is 3 weeks)Description: Radiological response will be evaluted using Recist Version 1.1 Criteria
Measure: Radiological Response Time: At the end of Cycle 4 (each cycle is 3 weeks)Description: Evaluate changes in viral load with study treatment
Measure: Changes in Viral Load Time: At the end of Cycle 4 (each cycle is 3 weeks)Description: Cytokine secretion assays will be performed on blood samples before, during, and after treatment.
Measure: Change in Cytokine Secretion Assays Time: 36 monthsDescription: Baseline immune biomarkers (e.g. PD-L1 expression, composition of T cells in tumor microenvironment) using multiplex IHC will be compared between responders and non-responders to find predictive biomarkers associated with response to treatment.
Measure: Correlation of Multiplex IHC to response Time: 36 monthsDescription: The blood tumor mutational burden (bTMB) between responders and non-responders will be compared.
Measure: Correlation of bTMB and treatment outcome Time: 36 monthsAllocation: N/A
Single Group Assignment
There are 2 SNPs
Exclusion Criteria: 1. Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) and/or ALK translocations by locally approved laboratory testing including blood-based liquid biopsy. --- L858R ---
Exclusion Criteria: 1. Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) and/or ALK translocations by locally approved laboratory testing including blood-based liquid biopsy. --- L858R --- --- L861Q ---