Durvalumab in Combination With Chemotherapy in Virus-infected Patients With Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04499053|
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small Cell Lung||Drug: Durvalumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Durvalumab (MEDI4736) in Combination With Chemotherapy in Virus-infected Patients With Non-small Cell Lung Cancer|
|Actual Study Start Date :||December 9, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: durvalumab (MEDI4736)
Durvalumab 1500 mg, intravenous, every 3 weeks for 4 cycles, followed by 1500 mg, intravenous, every 4 weeks (maintenance treatment)
durvalumab in combination with platinum-based doublet chemotherapy. 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.
- Adverse Events [ Time Frame: At the end of Cycle 4 (each cycle is 3 weeks) ]Incidence of treatment-emergent Adverse Events according to NCI CTCAE v5.0.
- Radiological Response [ Time Frame: At the end of Cycle 4 (each cycle is 3 weeks) ]Radiological response will be evaluated using Recist Version 1.1 Criteria
- Changes in Viral Load [ Time Frame: At the end of Cycle 4 (each cycle is 3 weeks) ]Evaluate changes in viral load with study treatment
- Change in Cytokine Secretion Assays [ Time Frame: 36 months ]Cytokine secretion assays will be performed on blood samples before, during, and after treatment.
- Correlation of Multiplex IHC to response [ Time Frame: 36 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499053
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Ashlyn Wallace 202-687-4773 email@example.com|
|Principal Investigator: Chul Kim, MD|
|Medstar Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Shovana Okobi 202-877-2749 Shovana.S.Cajas@medstar.net|
|Principal Investigator: Irena Veytsman, MD|
|United States, Maryland|
|Harry and Jeannette Weinberg Cancer Institute at Franklin Square||Recruiting|
|Baltimore, Maryland, United States, 21237|
|Contact: Jean Flack 443-777-7364 firstname.lastname@example.org|
|Principal Investigator: Suman Rao, MD|
|Study Chair:||Chul Kim, MD||Georgetown University|