OncoMatch/Clinical Trials/NCT07772895
Pemefolacianine for IMI of Lung Cancer
Is NCT07772895 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Pemefolacianine Cohort 1 in Part A and Pemefolacianin Cohort 2 in Part B for lung cancer (locally advanced or metastatic).
Treatment: Pemefolacianine Cohort 1 in Part A · Pemefolacianin Cohort 2 in Part B — The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Prior therapy
Cannot have received: Pemefolacianine for Injection (Pemefolacianine for Injection)
the patient has received Pemefolacianine for Injection previously
Cannot have received: radiation therapy to the chest
History of radiation therapy to the chest
Lab requirements
Kidney function
creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula
Liver function
Total bilirubin level >1.5 times upper limit of normal at screening; AST/ALT > 2.5 times the upper limit of normal (ULN) at screening
Cardiac function
History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) > 470 ms
Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula... Total bilirubin level >1.5 times upper limit of normal at screening; AST/ALT > 2.5 times the upper limit of normal (ULN) at screening... History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) > 470 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Pennsylvania · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07772895 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Pemefolacianine for Injection, radiation therapy to the chest disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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