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

Study summary

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 was 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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIrinotecan liposome injection and Topotecan

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 19, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?118 U.S. locations

Locations may change over time.

Who runs it?Ipsen

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Ipsen
Interventions being studied: Drug: Irinotecan liposome injection; Drug: Topotecan

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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. 1. Patients with asymptomatic CNS metastases prior to enrollment 2. Prior radiation for CNS metastatic disease is completed ≥4 weeks prior to enrollment 3. 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. 4. 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

National Jewish HealthDenver, Colorado
Rocky Mountain Cancer CentersDenver, Colorado
Florida Cancer Specialists (South Region)Fort Myers, Florida
Florida Cancer SpecialistsSt. Petersburg, Florida
Northwest Georgia Oncology CentersMarietta, Georgia
Cancer Treatment Centers of America-GeorgiaNewnan, Georgia
Illinois Cancer Care, PCPeoria, Illinois
Southern Maine Health CareBiddeford, Maine
University of Maryland Medical GroupBaltimore, Maryland
Henry Ford HospitalDetroit, Michigan
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan
Sparrow Regional Cancer CenterLansing, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 19, 2025. Always confirm current availability with the study team.

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