A Phase 2 diagnostic study with 68Ga-EVG321 in Patients with Small Cell Lung Cancer

Prior treatment

• Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical
• Organ allograft requiring immunosuppressive therapy

Other illness

• Known hypersensitivity to gallium-68, EVG321 or to any of the excipients of the IMP
• Any condition that precludes raised arms position for prolonged imaging purposes
• Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supra-ventricular arrhythmia)

Lab values

• Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, participants will be excluded if they meet the following criteria: • Hematologic (Platelets <75K/mcL; ANC <1.0 K/mcL) • Hepatic (Bilirubin >2.0 x ULN; AST/ALT >2.5 x ULN) • Renal (eGFR or creatinine clearance <30 mL)
• Marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval calculated with Fridericia's correction (QTcF > 470 msec for both males and females)
• History of clinical risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Age

• Other known co-existing malignancies with clinical relevance except participants with a history of malignant tumors in complete remission >3 years, with no evidence of recurrence <5 years

Other

• Persons with any kind of relationship with the investigator or employed by the sponsor or investigator
• Persons held in an institution by legal or official order.
• Claustrophobia interfering with PET/CT imaging
• Pregnancy, breast-feeding
• Participants with bladder outflow obstruction or unmanageable urinary incontinence

• Signed and dated ICF prior to any study-mandated procedure
• Male or female participants aged 18 years old and above at the time of signing the ICF
• ECOG performance status 0, 1 or 2
• Participants with histologically or cytologically confirmed small cell lung cancer (SCLC)
• Participants with evaluable ex-vivo tumour tissue
• Women of childbearing potential (WOCBP) defined as all women physiologically capable of becoming pregnant, must have a documented negative urine/serum pregnancy test. WOCBP who are sexually active, must agree to use highly effective means of contraception (as per CTFG criteria, refer to Appendix A of protocol) during the study period and for at least 7 months after study drug discontinuation.
• Sexually active male participants must agree to use condoms throughout the study period and for 4 months after study drug discontinuation if their female partner is of child-bearing potential and is using no highly effective methods of contraception, or have documented sterilization by vasectomy. In addition, male participants agree not to donate semen during the same period.