Imaging T-cell activation in advanced lung cancer
Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy
This study is testing if a special type of imaging can help track how well immunotherapy is working in people with advanced lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CellSight Technologies, Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Trial ID | NCT04726215 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the immunological response to checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer (NSCLC) using [18F]F AraG PET imaging. Approximately 50 patients will undergo two PET/CT scans with [18F]F AraG at different time points: one before treatment and one shortly after receiving immunotherapy. The study aims to quantify changes in [18F]F AraG PET signal and correlate these changes with radiographic responses to treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed advanced NSCLC who are scheduled to receive immunotherapy.
Not a fit: Patients with serious comorbidities, pregnant or nursing women, and those with severe claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune responses in lung cancer patients undergoing immunotherapy, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies using PET imaging to evaluate immunotherapy responses have shown promise, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease. 2. RECIST measurable disease. 3. ECOG performance status of 0, 1 or 2. 4. Life expectancy \>/= 6 months at enrollment. 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.
Where this trial is running
Palo Alto, California and 2 other locations
- Palo Alto Veterans Institute of Research — Palo Alto, California, United States (Recruiting)
- Sutter Cancer Center — Sacramento, California, United States (Recruiting)
- Stony Brook University — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Deepak Behera, MD — CellSight Technologies, Inc.
- Study coordinator: Samuel Quezada
- Email: squezada@cellsighttech.com
- Phone: 6507991589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.