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Durvalumab and Tremelimumab with Chemotherapy for NSCLC in HIV-positive Patients

This study is testing a combination of two drugs, durvalumab and tremelimumab, along with standard chemotherapy for people with advanced non-small cell lung cancer (NSCLC) who also have HIV. You could be eligible if you have stage IV NSCLC, have not had previous treatment for this stage, and have been on effective HIV medication for at least 4 weeks. The study aims to see how safe and effective this drug combination is. Researchers will be looking at side effects and how well the tumors respond to treatment by the end of the fourth treatment cycle. Up to 18 patients are planned to join this study.

Study design
This is a Phase 2, open-label study, meaning both you and your doctors will know which treatments you are receiving. It is not randomized, and aims to enroll up to 18 participants.
What's involved
You would receive durvalumab and tremelimumab with chemotherapy every three weeks for 4 cycles, followed by maintenance durvalumab (and possibly pemetrexed) every four weeks. A dose of tremelimumab will also be given at week 16.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure side effects and tumor response at the end of Cycle 4 (which is 12 weeks into treatment).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04499053

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Georgetown University
~18 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:DurvalumabTremelimumab

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over At the end of Cycle 4 (each cycle is 3 weeks)
+1 more outcome measured

Conditions

Carcinoma, Non-Small Cell Lung

Explore related trials

Lung Non-Small Cell CarcinomaCD4 GeneHIV Infection

Where it's being run

4 sites across 2 states
District of Columbia2
Maryland2

Study leadership

  • Chul Kim, MD · STUDY_CHAIR · Georgetown University

Who to contact

Jenny Crawford
[email protected]
202-687-0893
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented HIV viral load \< 400 copies/mL
No AIDS-defining opportunistic infections within the last 12 months
No concurrent incurable AIDS-defining malignancy 3. Age \> 18 years at time of study entry. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Body weight \>30kg 6. Adequate normal organ and marrow function as defined below:
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1,000 per mm3
Platelet count ≥ 100,000 per mm3
CD4 T-cell count ≥ 100 per mm3 for HIV-infected patients
Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 9. Must have a life expectancy of at least 12 weeks.

What this trial measures

  • Adverse EventsAt the end of Cycle 4 (each cycle is 3 weeks)

    Incidence of treatment-emergent Adverse Events according to NCI CTCAE v5.0.

  • Radiological ResponseAt the end of Cycle 4 (each cycle is 3 weeks)

    Radiological response will be evaluated using Recist Version 1.1 Criteria