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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT04499053
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Carcinoma, Non-Small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    durvalumab 1500 mg, intravenous, every 3 weeks for 4 cycles, followed by 1500 mg, intravenous, every 4 weeks (maintenance treatment)
  • Tremelimumab — DRUG
    tremelimumab 75 mg, intravenous, every 3 weeks for 4 cycles. A dose of tremelimumab 75 mg will be given at week 16.

Study Details

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.

Key Dates

Start date
Dec 9, 2020
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab (MEDI4736) and tremelimumab
    Durvalumab in combination with tremelimumab and 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 with durvalumab in maintenance.

Primary Outcome Measure

Adverse Events [ Time Frame: At the end of Cycle 4 (each cycle is 3 weeks) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Jenny Crawford
[email protected]
202-687-0893
Chul Kim, MD (PRINCIPAL_INVESTIGATOR)
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010
Leila Sounna
[email protected]
202-877-4775
Stephen Liu, MD (PRINCIPAL_INVESTIGATOR)
Harry and Jeannette Weinberg Cancer Institute at Franklin SquareBaltimoreMaryland21237
Amy Avergas
[email protected]
443-777-8876
Kevin Chen, MD (PRINCIPAL_INVESTIGATOR)
Marlene and Stewart Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Kaylee Martin
[email protected]
410-328-2288
Katherine Scilla, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCMedstar Washington Hospital Center· Washington D.C., DCHarry and Jeannette Weinberg Cancer Institute at Franklin Square· Baltimore, MDMarlene and Stewart Greenebaum Comprehensive Cancer Center· Baltimore, MD

Related Studies