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NCT03224871 · ClinicalTrials.gov registry record · Early Phase 1
UCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC.
A Early Phase 1 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT03224871: Completed Early Phase 1 study, sponsored by University of California, Davis.
NCT03224871 is a Early Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03224871, a Early Phase 1 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The advent of checkpoint blockade immunotherapy has revolutionized the management of metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and durable responses with these agents the majority of patients fail to respond. The investigators hypothesize that a novel strategy combining radiotherapy and intralesional interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade therapy and offer significant clinical benefit to patients who fail to respond to checkpoint blockade alone. The investigators propose a microtrial testing the feasibility of a bold combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and check-point blockade for metastatic non-small cell lung cancer patients who have progressed after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.
Primary Outcome
A dose limiting toxicity (DLT) will be defined as a treatment related grade 3-4 non-hematologic toxicity and will require dose de-escalation. If a DLT does not resolve within 5 days, is not responsive to management, or occurs at the lowest dose level (1 million IU IL-2) after de-escalation then that patient will be removed from trial and the therapy will be deemed intolerable. Therapy will be deemed safe and tolerable if no greater than 33% of patients find the treatment intolerable.
Interventions
- DRUG Pembrolizumab
- DRUG Nivolumab
- RADIATION Radiotherapy
- DRUG Intralesional IL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-08-11 |
| Est. Completion | 2020-01-10 |
| Phase | Early Phase 1 |
What the finished NCT03224871 record still lists
NCT03224871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03224871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03224871 about?
NCT03224871 is a clinical study titled "UCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC.". The advent of checkpoint blockade immunotherapy has revolutionized the management of metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and durable responses with these agents the majority of patients fail to respond. The investigators hypothesize that a novel str...
What is the current status of trial NCT03224871?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2017-08-11. Estimated completion is 2020-01-10.
What interventions are being tested in trial NCT03224871?
The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), Radiotherapy (RADIATION), Intralesional IL-2 (DRUG).
Who is sponsoring clinical trial NCT03224871?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03224871's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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