Actively Recruiting
Phase II Trial of Durvalumab and Tremelimumab With Chemotherapy in HIV-Infected Patients With Non-Small Cell Lung Cancer
Led by Georgetown University · Updated on 2026-03-16
18
Participants Needed
4
Research Sites
43 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of durvalumab and tremelimumab combined with standard platinum-based chemotherapy in patients with stage IV Non-Small-Cell Lung Cancer (NSCLC) who also have HIV infection. This phase II trial focuses on this specific population to understand how these treatments work together in this context. Participants will receive four cycles of treatment every three weeks, including durvalumab (1500 mg), tremelimumab (75 mg), and platinum-based chemotherapy tailored to tumor type. After these induction cycles, patients showing stable disease or better may continue maintenance therapy with durvalumab every four weeks, with or without pemetrexed for non-squamous NSCLC. A single additional dose of tremelimumab is given at week 16. During the study, researchers will monitor adverse events and tumor response using established criteria after four cycles. They will also assess changes in HIV viral load and immune markers over time. Participants will undergo regular visits, scans, and laboratory tests to evaluate treatment effects and safety. The study plans to enroll up to 18 patients and will continue until December 2027.
CONDITIONS
Brief Title
Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage IV Non-Small Cell Lung Cancer who have not received previous systemic therapy for stage IV disease
- HIV infection with effective combination anti-retroviral therapy for at least 4 weeks
- Documented HIV viral load less than 400 copies/mL
- No AIDS-defining opportunistic infections within the last 12 months
- No concurrent incurable AIDS-defining malignancy
- Age 18 years or older at study entry
- ECOG performance status of 0 to 2
- Body weight over 30 kg
- Adequate organ and marrow function including specified blood counts and liver and kidney function
- For women, evidence of post-menopausal status or negative pregnancy test if pre-menopausal
- Willingness and ability to comply with study protocol and visits
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Presence of sensitizing EGFR mutations or ALK translocations
- Coinfection with HIV and untreated HBV or HCV (treated or cured allowed)
- No measurable disease
- Recent anticancer therapy within 21 days prior to study treatment
- Unresolved grade 2 or higher toxicity from previous cancer treatments except alopecia or vitiligo
- Recent whole brain radiation therapy within 2 weeks prior to treatment
- Major surgery within 4 weeks prior to study drug or unresolved side effects
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- Uncontrolled illnesses including infections, heart failure, hypertension, angina, arrhythmia, lung disease, or psychiatric conditions
- Untreated central nervous system metastases or leptomeningeal disease
- Active tuberculosis
- Recent use of immunosuppressive medication with exceptions for certain steroids
- Receipt of live vaccine within 30 days prior to study drug
- Pregnant or breastfeeding women, or those unwilling to use effective contraception
- Known allergy to study drugs or their components
- Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy within 12 months
- Investigator judgment of unsuitability for study participation or compliance issues
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks for induction plus ongoing maintenance treatment
Participants receive 4 cycles of combination treatment with durvalumab and tremelimumab every 3 weeks alongside platinum-based doublet chemotherapy. Only participants who achieve stable disease or better after these cycles continue with maintenance treatment using durvalumab every 4 weeks, with or without pemetrexed depending on tumor type. A single dose of tremelimumab is given at week 16.
Visits every 3 weeks for 4 cycles, then maintenance visits every 4 weeks
Trial Site Locations
Total: 4 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
Harry and Jeannette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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