Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

Inclusion Criteria

• At least 18 years of age.
• Able to understand and provide an informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy >12 weeks
• Histopathologically or cytologically confirmed small cell lung cancer
• Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non measurable lesions only are eligible).
• Radiologically confirmed progression on or after first-line platinum based chemotherapy (carboplatin or cisplatin), or chemo-radiation including platinum-based chemotherapy for treatment of limited or extensive stage Small Cell Lung Cancer (SCLC). In addition to platinum-based regimen, one line of immunotherapy as monotherapy or in combination, in first or in second line setting is allowed.
• Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to Grade 1 or better, with the exception of alopecia, peripheral neuropathy, or ototoxicity).
• Adequate bone marrow reserves
• Adequate hepatic function
• Adequate renal function
• Electrocardiogram during the Screening period without any clinically significant findings, per investigator's assessment
• Patients with certain types of asymptomatic CNS metastases that meet ALL the following criteria are eligible.
• Patients with asymptomatic CNS metastases prior to enrollment
• Prior radiation for CNS metastatic disease is completed ≥4 weeks prior to enrollment
• CNS metastases that are stable or have decreased according to the post radiation follow-up scan that is conducted at least 4 weeks after completion of radiation treatment for CNS lesion.
• Patients have discontinued corticosteroids or are on stable low-dose steroids (prednisone or equivalent 10 mg daily or less) for at least 1 week after completion of radiation for CNS lesion prior to enrollment.

Exclusion Criteria

• Any medical or social condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
• Pregnant or breast feeding;
• Patients with large cell neuroendocrine lung carcinoma.
• Patients who have received prior topoisomerase I inhibitor treatment, retreatment with platinum-based regimen, antibody-drug conjugates or molecular targeted agents, more than one line of immunotherapy, or any other additional regimen of prior cytotoxic chemotherapy.
• Patients with the symptomatic Central Nervous System (CNS) metastasis and/or who have developed new or progressive brain metastasis within 3 months following prophylactic and/or therapeutic cranial radiation (whole brain stereotactic radiation).
• Patients with carcinomatous meningitis.
• Unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving the first dose of irinotecan liposome injection.
• Have a previous or concurrent cancer that is distinct in primary (non-pulmonary) site or SCLC histology
• Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is less, prior to the first scheduled day of dosing in this study.
• Severe cardiovascular and pulmonary diseases
• New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled blood pressure.
• Active infection
• Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or topotecan.
• Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1.