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.
This is an open-label, non-randomized phase II trial of durvalumab in combination with
platinum-based doublet chemotherapy. Patients with stage IV NSCLC with HIV (cohort 1) or
HBV/HCV (cohort 2) infection will be eligible. Patients will receive standard chemotherapy
plus durvalumab (1500 mg Q3W) every three weeks for 4 cycles, followed by maintenance
treatment with durvalumab (1500 mg Q4W; with or without pemetrexed for non-squamous NSCLC per
the discretion of the investigator).
Patient will be enrolled into the trial using an optimal two-stage phase II trial design. If
0 of the 7 achieved a response, no further patients will be enrolled in that cohort. If 1 or
more of the first 7 patients has a response, accrual would continue until a total of 18
patients have been enrolled in that cohort. Objective response will be evaluated using the
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Safety and tolerability will be
evaluated by assessing the incidence of treatment-related grade 3 or higher AEs.
Treatment-related grade 3 or higher AEs will be defined as any grade 3 or higher AEs that
occur during the first 42 days of treatment and are related to the study treatment. AEs will
be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Subjects will receive 4 cycles of combination treatment: durvalumab (1500 mg every 3 weeks)
in combination with platinum-based doublet chemotherapy. The platinum-based doublet
chemotherapies (carboplatin plus paclitaxel/nab-paclitaxel vs. pemetrexed plus
carboplatin/cisplatin) are dependent on the tumor histology of the subject (squamous vs.
non-squamous). Only subjects who achieve stable disease or better radiological response after
4 cycles of induction treatment will be eligible to continue study treatment in maintenance.
The choice to treat non-squamous subjects with pemetrexed maintenance after the 4 induction
cycles will be determined by the investigator.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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