RecruitingPhase 2NCT04499053

Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer

A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer


Sponsor

Georgetown University

Enrollment

18 participants

Start Date

Dec 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection 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. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two immunotherapy drugs (durvalumab and tremelimumab) with standard chemotherapy is safe and effective for people with advanced lung cancer (non-small cell type) who also have HIV. People with HIV are often excluded from cancer trials, and this study specifically includes them. **You may be eligible if...** - You have stage IV non-small cell lung cancer (advanced lung cancer) - You have not yet received chemotherapy for your advanced-stage lung cancer - You are living with HIV and have been on effective HIV medications (antiretroviral therapy) for at least 4 weeks - Your HIV viral load is below 400 copies/mL - You have had no AIDS-defining infections in the past year **You may NOT be eligible if...** - You have received prior systemic therapy for your advanced lung cancer - Your HIV is not well-controlled on medications - You have had prior treatment with immunotherapy drugs - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDurvalumab

durvalumab 1500 mg, intravenous, every 3 weeks for 4 cycles, followed by 1500 mg, intravenous, every 4 weeks (maintenance treatment)

DRUGTremelimumab

tremelimumab 75 mg, intravenous, every 3 weeks for 4 cycles. A dose of tremelimumab 75 mg will be given at week 16.


Locations(4)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Harry and Jeannette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04499053


Related Trials