NCT06107374 Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG
| NCT ID | NCT06107374 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | CellSight Technologies, Inc. |
| Condition | Advanced Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2023-11-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease. 2. Measurable disease. 3. ECOG performance status of 0, 1 or 2. 4. Subjects are willing to be followed at the University of Iowa. Exclusion Criteria: 1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives. 2. Pregnant women or nursing mothers. 3. Patients with severe claustrophobia.
Contact & Investigator
Muhammad Furqan, M.D.
PRINCIPAL INVESTIGATOR
Holden Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06107374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06107374 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06107374 currently recruiting?
Yes, NCT06107374 is actively recruiting participants. Contact the research team at amy-mundisev@uiowa.edu for enrollment information.
Where is the NCT06107374 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT06107374 clinical trial?
NCT06107374 is sponsored by CellSight Technologies, Inc.. The principal investigator is Muhammad Furqan, M.D. at Holden Comprehensive Cancer Center. The trial plans to enroll 20 participants.
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