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NCT04499053 · ClinicalTrials.gov registry record · Phase 2
Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer
A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 4
- Study locations
NCT04499053: Recruiting Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Georgetown University.
NCT04499053 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 18 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04499053, a Phase 2 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Incidence of treatment-emergent Adverse Events according to NCI CTCAE v5.0.
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
Study Locations (4)
District of Columbia
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.
- Medstar Washington Hospital Center - Washington D.C.
Maryland
- Marlene and Stewart Greenebaum Comprehensive Cancer Center - Baltimore
- Harry and Jeannette Weinberg Cancer Institute at Franklin Square - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-12-09 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT04499053 shows while recruiting
NCT04499053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT04499053 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT04499053 about?
NCT04499053 is a clinical study titled "Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer". 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 durvalu...
What is the current status of trial NCT04499053?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-12-09. Estimated completion is 2027-12.
What conditions does trial NCT04499053 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT04499053?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT04499053?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04499053 being conducted?
This trial has 4 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04499053's enrollment target sits among peer trials
18 120th of 130 higher than 9 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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