Pemefolacianine for IMI of Lung Cancer

Prior treatment

• No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery (e.g., Cytalux)
• Received a systemic investigational drug of any kind for any indication within 4 weeks or 5 half-lives prior to administration of Pemefolacianine for Injection and/or the patient has received Pemefolacianine for Injection previously

Other illness

• Contraindications for surgery or any medical condition that in the opinion of the investigator could significantly jeopardize the safety of the subject
• History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
• History of radiation therapy to the chest

Lab values

• Patients with impaired renal function as defined by a creatinine clearance (CrCl) \<60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
• 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
• Total bilirubin level \>1.5 times upper limit of normal at screening
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \> 2.5 times the upper limit of normal (ULN) at screening
• The patient is pregnant, breast feeding, or plans to become pregnant within 6 months of the administration of Pemefolacianine for Injection or has a positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential

Other

• Known sensitivity to fluorescent light

• Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
• Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
• Are scheduled to undergo surgical thoracoscopy or open surgery (thoracotomy) and resection of the lung.
• If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
• Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments