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

Trial Status: Active

A Randomized, Open Label Phase 3 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 The study will be conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

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), 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.

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 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.


Emory University Hospital / Winship Cancer Institute
Status: ACTIVE


University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Rebecca Hudson
Phone: 410-328-4827

New York

Roswell Park Cancer Institute
Status: ACTIVE


Case Comprehensive Cancer Center
Status: ACTIVE


Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

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

Lead Organization

  • Primary ID MM-398-01-03-04
  • Secondary IDs NCI-2018-02955, 2017-004261-26
  • ID NCT03088813