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



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:April 25, 2018
End Date:December 2022

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RESILIENT: 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

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

The study will be conducted in two parts:

Part 1: Open-label dose finding study of irinotecan liposome injection. Approximately 24-36
patients will be enrolled.

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
study

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.

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

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.
We found this trial at
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Greenville, South Carolina 29605
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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201 Borella Road
Albury, New South Wales 2640
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Biddeford, Maine 04005
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Denver, Colorado 80218
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East Setauket, New York 11733
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Lewiston, Maine 04240
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Orlando, Florida 32804
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Vancouver, Washington 98683
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Worcester, Massachusetts 01608
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