Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
- 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), immunotherapy, or chemo-radiation including platinum-based chemotherapy for treatment of limited or extensive stage Small Cell Lung Cancer (SCLC).
- 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).
- 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 ≥2 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.
- 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 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.
- Patients with the symptomatic Central Nervous System (CNS) metastasis and/or who have developed new or progressive brain metastasis 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.
The study will be conducted in two parts:
Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were
Part 1 Primary Objectives:
- Describe the safety and tolerability of irinotecan liposome injection monotherapy
administered every 2 weeks
- Determine the optimal irinotecan liposome injection monotherapy dose for Part 2 of this
Part 2: A randomized, efficacy study of irinotecan liposome injection versus IV topotecan.
Approximately 450 patients will be enrolled in part 2.
Part 2 objectives: Detailed in the Primary & Secondary outcome measure sections.
Trial Phase Phase II/III
Trial Type Treatment
- Primary ID MM-398-01-03-04
- Secondary IDs NCI-2018-02955, 2017-004261-26
- Clinicaltrials.gov ID NCT03088813