Small Cell Lung Cancer (SCLC) Clinical Trials

∙ In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Signed and written informed consent

• Age 18 years or older

• Patients with pathology proven metastatic SCLC

• Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy

• WHO/ECOG PS 0-1

• Estimated life expectancy 12 weeks or more

• At least one asymptomatic active (newly diagnosed or unequivocally progressive) untreated brain metastasis ≥ 5mm:

‣ Subjects with largest measurable intracranial lesion ≥5 mm but \<10mm may be allowed to enroll upon agreement with investigator (for patients with target lesions of ≥ 5mm but \<10 mm, 1.5 mm slice thickness brain MRI is required).

⁃ Untreated refers to the lesion not being previously treated with stereotactic radiosurgery/therapy (SRS/SRT) or surgery.

⁃ Prior treatment with whole brain radiation therapy or local surgery is permissible provided unequivocal progression in the lesion has since occurred

• For at least 7 days prior to study start: Patient must be asymptomatic from CNS metastases and on a stable dose of anti-epileptics and corticosteroids. Maximum dose of steroids is 10 mg prednisolone or equivalent/day, dose should be noted.

• Adequate organ and bone marrow function, defined as:

• a. Hematological function: i. Absolute neutrophil count ≥1.5 x109/L ii. Platelet count ≥ 100 x109/L iii. Hemoglobin ≥ 5.6 mmol/l b. Coagulation function: i. Protrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to start of study treatment.

• c. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Dietin Renal Disease (MDRD) calculation \> 30 mL/min/1.73 m2 d. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3x ULN (or \< 5x ULN for subjects with liver metastases) ii. Total bilirubin \< 1.5x ULN (or \< 2x ULN for subjects with liver metastases), except for subjects with Gilberts disease e. Pulmonary function: i. No clinically significant pleural effusion. Pleural effusions managed with indwelling pleural catheter (eg, PleurX) are allowed.

∙ ii. Baseline oxygen saturation \> 90% on room air f. Cardiac function: i. Cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding