For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. At least 18 years of age.
  2. Able to understand and provide an informed consent
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Life expectancy >12 weeks
  5. Histopathologically or cytologically confirmed small cell lung cancer
  6. Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non measurable lesions only are eligible).
  7. 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.
  8. 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).
  9. Adequate bone marrow reserves
  10. Adequate hepatic function
  11. Adequate renal function
  12. Electrocardiogram during the Screening period without any clinically significant findings, per investigator's assessment
  13. Patients with certain types of asymptomatic CNS metastases that meet ALL the following criteria are eligible.
  14. Patients with asymptomatic CNS metastases prior to enrollment
  15. Prior radiation for CNS metastatic disease is completed ≥4 weeks prior to enrollment
  16. 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.
  17. 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

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
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    Study’s details


    Contition

    Small Cell Lung Cancer

    Age (in years)

    18 - 200

    Phase

    Phase 2/Phase 3

    Participants needed

    480

    Est. Completion Date

    Apr 2023

    Treatment type

    Interventional


    Sponsor

    Ipsen

    ClinicalTrials.gov identifier

    NCT03088813

    Study number

    MM-398-01-03-04

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