IPSEN (RESILIENT): A randomized, open-label phase III study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy

Including patients who:

• Are 18 years or older
• Are able to understand and provide an informed consent
• Have an ECOG performance status of 0 or 1
• Have life expectancy of >12 weeks
• Have histopathologically or cytologically confirmed small cell lung cancer
• Have evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non measurable lesions only are eligible)
• Have radiologically confirmed progression on or after first-line platinum-based chemotherapy (carboplatin or cisplatin), immunotherapy or chemo-radiation, including platinum-based chemotherapy for treatment of limited or extensive-stage SCLC
• Have recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to grade I or better, with the exception of alopecia)
• Have adequate bone marrow reserves
• Have adequate hepatic function and adequate renal function
• Have had an electrocardiogram during the screening period without any clinically significant findings, per investigator's assessment

Excluding patients who:

• Have had 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
• Are pregnant or breastfeeding
• Have large cell neuroendocrine lung carcinoma
• Have received prior topoisomerase I inhibitor treatment, retreatment with e 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
• Have symptomatic CNS metastasis and/or who have developed new or progressive brain metastasis following prophylactic and/or therapeutic cranial radiation (whole brain stereotactic radiation)
• Have carcinomatous meningitis
• Are unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least one week or strong CYP3A4 inducers at least two 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
• Have had investigational therapy administered within four weeks, or within a time interval less than at least five half-lives of the investigational agent, whichever is less, prior to the first scheduled day of dosing in this study
• Have severe cardiovascular and pulmonary diseases
• Have New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
• Have active infection
• Have known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products or topotecan
• Have clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion or diarrhea of >grade I

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