A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC

Inclusion criteria

• more than 18 years,
• Willing and able to sign written informed consent,
• Histologically confirmed diagnosis of adenocarcinoma NSCLC:

• positive mutated KRas homogeneous population for EGFR Wild type (WT) patients (exclusive with EGFR mutation)
• EGFR activating mutation (All mutations: 719, 790, 861, 858 or del exon 19 and exon 20),
• Patient with EGFR mutation will be sensitive to TKI
• Treatment naïve patients,
• Performance status ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) criteria,
• No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole,
• Adequate hematologic (ANC count ≥ 1,500/uL, platelet count ≥ 100,000/mm3), hepatic (bilirubin level ≤ 1.5 mg/dL, Transaminase (AST/ALT) ≤ 80 IU/L), and renal (creatinine concentration ≤ 1.5 mg/dL) function,
• Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs.

Exclusion criteria

• Known severe hypersensitivity to Gefitinib or Afatinib or any of the tablet excipients,
• Inability to swallow tablets,
• Other coexisting malignant disease,
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis),
• Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control,
• Subjects under guardianship, curators or judicial protection