Lung Cancer Clinical Trial
Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
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 will be conducted in two parts:
Dose determination of irinotecan liposome injection
A randomized, efficacy study of irinotecan liposome injection versus topotecan
Full Description
The study was conducted in two parts:
Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were 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 intravenous (IV) topotecan.
Approximately 450 patients will be enrolled in part 2.
Part 2 objectives: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with IV topotecan.
Eligibility Criteria
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), 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.
Patients with asymptomatic CNS metastases prior to enrollment
Prior radiation for CNS metastatic disease is completed ≥4 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 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.
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There are 50 Locations for this study
Denver Colorado, 80206, United States
Denver Colorado, 80218, United States
Fort Myers Florida, 33916, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Newnan Georgia, 30265, United States
Peoria Illinois, 61615, United States
Biddeford Maine, 04005, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Lansing Michigan, 48219, United States
Buffalo New York, 14263, United States
East Setauket New York, 11733, United States
Cleveland Ohio, 44106, United States
Massillon Ohio, 44646, United States
Oklahoma City Oklahoma, 73104, United States
Charleston South Carolina, 29414, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Spokane Washington, 99204, United States
Spokane Washington, 99208, United States
Albury New South Wales, 2640, Australia
Warrnambool Victoria, 3280, Australia
Wollongong , , Australia
Woolloongabba , , Australia
Brasschaat , , Belgium
Leuven , , Belgium
Libramont , , Belgium
Mechelen , , Belgium
Barretos , , Brazil
Ijuà , , Brazil
Nova Lima , , Brazil
Porto Alegre , , Brazil
Porto Alegre , , Brazil
Rio De Janeiro , , Brazil
Santo André , , Brazil
São José Do Rio Preto , , Brazil
Beijing , 10014, China
Bengbu , 23300, China
Changchun , 45000, China
Chengdu , 61004, China
Guangzhou , 51008, China
Hangzhou , 31002, China
Hubei , 43003, China
Linyi , , China
Zhengzhou , , China
Brest , , France
Marseille , , France
Saint-Priest-en-Jarez , , France
Saint-Quentin , 02321, France
Freiburg , 79106, Germany
Hamm , 50063, Germany
Heidelberg , 69126, Germany
Oldenburg , 26121, Germany
Budapest , , Hungary
Gyula , , Hungary
Szolnok , , Hungary
Törökbálint , , Hungary
Zalaegerszeg , , Hungary
Meldola , , Italy
Milano , , Italy
Udine , , Italy
Cheongju-si , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Suwon , , Korea, Republic of
Biała Podlaska , , Poland
Gdynia , , Poland
Olsztyn , , Poland
Poznań , , Poland
Poznań , , Poland
Bucuresti , , Romania
Cluj-Napoca , , Romania
Cluj-Napoca , , Romania
Craiova , , Romania
FloreÅŸti , , Romania
TimiÅŸoara , , Romania
Arkhangel'sk , , Russian Federation
Moscow , , Russian Federation
Omsk , , Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , , Russian Federation
Yaroslavl , , Russian Federation
Belgrade , , Serbia
Belgrade , , Serbia
Belgrad , , Serbia
Sremska Kamenica , , Serbia
Užice , 31000, Serbia
L'Hospitalet De Llobregat Barcelona, 08908, Spain
Alicante , , Spain
Barcelona , 08035, Spain
Madrid , 28041, Spain
Madrid , , Spain
Málaga , 29010, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Changhua , , Taiwan
Kaohsiung , , Taiwan
Taipei , 100, Taiwan
Taipei , , Taiwan
Taoyuan , 333, Taiwan
Adana , , Turkey
Edirne , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Malatya , , Turkey
TekirdaÄŸ , , Turkey
Chernivtsi , , Ukraine
Dnipro , , Ukraine
Kharkiv , 61070, Ukraine
Kremenchuk , 39617, Ukraine
Kryvyi Rih , , Ukraine
Luts'k , , Ukraine
Odesa , , Ukraine
Sumy , , Ukraine
Uzhgorod , 88000, Ukraine
Vyshhorod , 07352, Ukraine
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