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NCT06943664 · ClinicalTrials.gov registry record · Phase 2
Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Not yet
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT06943664: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT06943664 is a Phase 2 study that has not yet begun recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06943664, a Phase 2 study, has not yet begun recruiting, sponsored by Roswell Park Cancer Institute.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This phase II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that has spread from where it first started to other places in the body (metastatic). PIT is a treatment that combines drugs that become active when exposed to light, such as ASP-1929, with immunotherapy to target and kill tumor cells. ASP-1929 combines cetuximab with a light-sensitive component, sarotalocan. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called epidermal growth factor receptor (EGFR), which is found on some types of tumor cells. This may help keep tumor cells from growing. Sarotalocan is a fluorescent dye, infrared-activated fluorescent dye 700, that is light sensitive, and when activated by a special type of laser light, helps destroy or change tumor cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving PIT with ASP-1929 in combination with cemiplimab may kill more tumor cells in patients with refractory, inoperable, or metastatic stage IIIB-IV NSCLC.
Primary Outcome
Will be defined as the proportion of patients who have a partial or complete response to therapy and will be assessed according to immune-modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Cemiplimab
- OTHER Electronic Health Record Review
- BIOLOGICAL Cetuximab Sarotalocan Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2026-08-15 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 2 |
What is known before NCT06943664 opens enrollment
NCT06943664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06943664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06943664 about?
NCT06943664 is a clinical study titled "Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer". This phase II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that ...
What is the current status of trial NCT06943664?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2026-08-15. Estimated completion is 2028-05-01.
What interventions are being tested in trial NCT06943664?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cemiplimab (BIOLOGICAL), Electronic Health Record Review (OTHER), Cetuximab Sarotalocan Sodium (BIOLOGICAL).
Who is sponsoring clinical trial NCT06943664?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06943664's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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