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

Primary Purpose

Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Irinotecan liposome injection

Topotecan

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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.

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.

Sites / Locations

National Jewish Health
Rocky Mountain Cancer Centers
Florida Cancer Specialists (South Region)
Florida Cancer Specialists
Northwest Georgia Oncology Centers
Cancer Treatment Centers of America-Georgia
Illinois Cancer Care, PC
Southern Maine Health Care
University of Maryland Medical Group
Henry Ford Hospital
Cancer & Hematology Centers of Western Michigan
Sparrow Regional Cancer Center
Roswell Park Cancer Institute
North Shore Hematology Oncology Associates, PC
Case Western Reserve University
Tri County Hematology & Oncology Associates, Inc
University of Oklahoma Health Sciences Center
Charleston Hematology Oncology Associates, PA
Greenville Hospital System University Medical Center
Tennessee Oncology
MultiCare Health System Institute for Research and Innovation
Summit Cancer Treatment Center
Border Medical Oncology Research Unit
South West Healthcare
Southern Medical Day Care Centre
Princess Alexandra Hospital
AZ Klina
UZ Leuven
Centre Hospitalier de l'Ardenne
AZ Sint-Maarten
Hospital de Cancer de Barretos, Fundacoa Pio X II
Hospital de Caridade de Ijuí
Oncobio Servicos de Saude
HGB - Hospital Giovanni Battista - Mãe de Deus Center
Hospital Nossa Senhora da Conceição
INCA - Instituto Nacional de Câncer
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Beijing Cancer Hospital
The First Affiliated Hospital of Bengbu Medical College
The First Hospital of Jilin University
West China Hospital, Sichuan University
Guangdong Provincial People's Hospital
Zhejiang Cancer Hospital
Tongji Hospital
Linyi Cancer Hospital
Henan Cancer Hospital
CHU Brest - Hôpital Morvan
Hôpital Nord - CHU Marseille
Institut de Cancérologie de la Loire
Centre Hospitalier de Saint-Quentin
Universitaetsklinikum Freiburg
Evangelisches Krankenhaus Hamm GmbH
Universitaetsklinikum Heidelberg
Pius-Hospital Oldenburg
Semmelweis Egyetem
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Tudogyogyintezet Torokbalint
Zala Megyei Szent Rafael Korhaz
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Fondazione IRCCS Istituto Nazionale dei Tumori
Azienda Sanitaria Universitaria Integrata di Udine
Chungbuk National University Hospital
Asan Medical Center
The Catholic University of Korea, Seoul St. Mary's Hospital
The Catholic University of Korea, St. Vincent's Hospital
KO-MED Centra Kliniczne Biala Podlaska
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
Przychodnia Med-Polonia Sp. z o.o.
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
S.C Gral Medical S.R.L
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
S.C Medisprof S.R.L
S.C Centrul de Oncologie Sf. Nectarie S.R.L
S.C Radiotherapy Center Cluj S.R.L
Oncomed SRL
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
"VitaMed" LLC
BHI of Omsk region "Clinical Oncology Dispensary"
SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"
SPb SBIH "City Clinical Oncological Dispensary"
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
Clinical Center "Bezanijska kosa"
Oncomed System
Clinical Center Kragujevac
Institute for Pulmonary Diseases of Vojvodina
General Hospital Uzice
ICO l'Hospitalet - Hospital Duran i Reynals
Hospital General Universitario de Alicante
Hospital Universitari Vall d'Hebron
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Hospital Regional Universitario de Malaga
Hospital Universitario Virgen del Rocio
Hospital Universitari i Politecnic La Fe
Changhua Christian Hospital
Kaohsiung Chang Gung Memorial Hospital
National Taiwan University Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital, Linkou
Baskent University Adana Application and Research Center
Trakya University Medical Faculty
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Inonu Uni. Med. Fac.
Namik Kemal University
CI Chernivtsi RC Oncological Dispensary
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Communal Non-profit Enterprise Regional Center of Oncology
Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council
CI Kryvyi Rih Oncological Dispensary of DRC
Treatment-Prevention Institution Volyn Regional Oncological Dispensary
Odesa Regional Oncologic Dispensary
RCI Sumy Regional Clinical Oncological Dispensary
CCCH City Oncological Center SHEI Uzhgorod NU
Medical Clinic Innovacia, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Part 1: Experimental Arm, dose level 1

Part 1: Experimental Arm, dose level 2

Part 2: Experimental Arm

Part 2: Control Arm

Arm Description

Irinotecan liposome injection

Topotecan

Outcomes

Primary Outcome Measures

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

An adverse event (AE) was any untoward medical occurrence in a participant following or during exposure to a study treatment, whether or not causally related to the study treatment. An undesirable medical condition could be symptoms, signs or abnormal results of an investigation. An SAE was any AE that: resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; resulted in congenital anomaly or birth defect; or was medically important. A TEAE was any AE that occurred or worsened on or after the day of first dose of study treatment and within 30 days after discontinuation of study treatment.

Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)

A TEAE was considered as DLT if it occurred during the safety evaluation period (i.e. first 28 days of treatment or 14 days after the second dose of study treatment if there was a treatment delay due to non-DLT related reasons) and were deemed related to the study treatment by the investigator. The determination of whether an Adverse Event was considered a Dose Limiting Toxicity was made by the Safety Review Committee (SRC) comprising the Part 1 Investigators and the Medical Monitor(s) of the Sponsor.

Part 2: Overall Survival (OS)

The OS was defined as the time from randomization date to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status.

Secondary Outcome Measures

Part 1: Objective Response Rate (ORR)

The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) recorded from date of first dose of study treatment until documented PD or death. ORR analysis was based on BOR using RECIST v1.1 per investigator assessment. Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had computed tomography (CT)-scans and brain magnetic resonance imaging (MRI) every 6 weeks to measure tumor lesion size. This was continued throughout treatment until progressive disease (PD) or commencement of new anti-neoplastic therapy.

Part 1: Progression-Free Survival (PFS)

The PFS was defined as time from first dose of study treatment to the first documented objective PD using RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, progression is defined as at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Part 1: OS

The OS was defined as the time from first dose of study treatment to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status.

Part 2: PFS

The PFS was defined as time from randomization to first documented objective PD using RECIST 1.1 (or response assessment in neuro-oncology brain metastases [RANO-BM] criteria for central nervous system [CNS] lesions) as assessed by blinded independent central review (BICR) or death due to any cause, whichever occurred first. Per RECIST 1.1, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Part 2: ORR

The ORR was defined as percentage of participants with a BOR characterized as either a CR or PR, recorded from randomization until documented PD or death relative to the total number of participants. ORR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Part 2: Median Duration of Response (DoR)

The DoR was defined as time from the first documented objective response (CR or PR, whichever was earlier) to the date of first documented PD or death due to any cause. The DoR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions and PR is >=30% decrease in the sum of the longest diameter of target lesions. The DoR was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Part 2: Median Time to Objective Response (OR)

Time to OR as per RECIST v1.1 Criteria according to BICR was defined as time from the date of randomization to the date of first documented objective tumor response (CR or PR, whichever was first). Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesion. Participants with a new anti-cancer therapy prior to OR were censored at the last tumor assessment prior to new anti-cancer therapy. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy.

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Scores range from 0-100 and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in dyspnea scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Score ranges from 0-100 scale and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in cough scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

Full Information

NCT ID

NCT03088813

First Posted

March 9, 2017

Last Updated

September 27, 2023

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT03088813

Brief Title

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

Acronym

RESILIENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

April 25, 2018 (Actual)

Primary Completion Date

February 8, 2022 (Actual)

Study Completion Date

July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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: Dose determination of irinotecan liposome injection A randomized, efficacy study of irinotecan liposome injection versus topotecan

Detailed Description

The study was conducted in two parts: Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were planned to 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 intravenous (IV) topotecan. Approximately 450 patients were planned to 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Randomized

Enrollment

491 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Experimental Arm, dose level 1

Arm Type

Experimental

Arm Description

Irinotecan liposome injection

Arm Title

Part 1: Experimental Arm, dose level 2

Arm Type

Experimental

Arm Description

Irinotecan liposome injection

Arm Title

Part 2: Experimental Arm

Arm Type

Experimental

Arm Description

Irinotecan liposome injection

Arm Title

Part 2: Control Arm

Arm Type

Active Comparator

Arm Description

Topotecan

Intervention Type

Drug

Intervention Name(s)

Irinotecan liposome injection

Other Intervention Name(s)

ONIVYDE®

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Topotecan

Intervention Description

Primary Outcome Measure Information:

Title

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

Description

Time Frame

The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 506 days

Title

Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)

Description

Time Frame

From the start of the first study treatment administration (Day 1) up to 14 days after the second dose of study treatment administration, a maximum of 42 days

Title

Part 2: Overall Survival (OS)

Description

Time Frame

From date of randomization (within 7 days before start of study treatment) until death. Assessed up to Part 2 DCO date of 08 February 2022 (approximately 900 days)

Secondary Outcome Measure Information:

Title

Part 1: Objective Response Rate (ORR)

Description

Time Frame

RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days

Title

Part 1: Progression-Free Survival (PFS)

Description

Time Frame

Title

Part 1: OS

Description

Time Frame

From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days)

Title

Part 2: PFS

Description

Time Frame

Title

Part 2: ORR

Description

Time Frame

Title

Part 2: Median Duration of Response (DoR)

Description

Time Frame

Title

Part 2: Median Time to Objective Response (OR)

Description

Time Frame

Title

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12

Description

Time Frame

Baseline (Day 1) and Week 12

Title

Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12

Description

The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Score ranges from 0-100 scale and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in cough scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy.

Time Frame

Baseline (Day 1) and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

National Jewish Health

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Rocky Mountain Cancer Centers

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Florida Cancer Specialists (South Region)

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Northwest Georgia Oncology Centers

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Cancer Treatment Centers of America-Georgia

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Illinois Cancer Care, PC

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61615

Country

United States

Facility Name

Southern Maine Health Care

City

Biddeford

State/Province

Maine

ZIP/Postal Code

04005

Country

United States

Facility Name

University of Maryland Medical Group

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Cancer & Hematology Centers of Western Michigan

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Sparrow Regional Cancer Center

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48219

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

North Shore Hematology Oncology Associates, PC

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Case Western Reserve University

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Tri County Hematology & Oncology Associates, Inc

City

Massillon

State/Province

Ohio

ZIP/Postal Code

44646

Country

United States

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Charleston Hematology Oncology Associates, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Greenville Hospital System University Medical Center

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Tennessee Oncology

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

MultiCare Health System Institute for Research and Innovation

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Summit Cancer Treatment Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Border Medical Oncology Research Unit

City

Albury

State/Province

New South Wales

ZIP/Postal Code

2640

Country

Australia

Facility Name

South West Healthcare

City

Warrnambool

State/Province

Victoria

ZIP/Postal Code

3280

Country

Australia

Facility Name

Southern Medical Day Care Centre

City

Wollongong

Country

Australia

Facility Name

Princess Alexandra Hospital

City

Woolloongabba

Country

Australia

Facility Name

AZ Klina

City

Brasschaat

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

Country

Belgium

Facility Name

Centre Hospitalier de l'Ardenne

City

Libramont

Country

Belgium

Facility Name

AZ Sint-Maarten

City

Mechelen

Country

Belgium

Facility Name

Hospital de Cancer de Barretos, Fundacoa Pio X II

City

Barretos

Country

Brazil

Facility Name

Hospital de Caridade de Ijuí

City

Ijuí

Country

Brazil

Facility Name

Oncobio Servicos de Saude

City

Nova Lima

Country

Brazil

Facility Name

HGB - Hospital Giovanni Battista - Mãe de Deus Center

City

Porto Alegre

Country

Brazil

Facility Name

Hospital Nossa Senhora da Conceição

City

Porto Alegre

Country

Brazil

Facility Name

INCA - Instituto Nacional de Câncer

City

Rio De Janeiro

Country

Brazil

Facility Name

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

City

Santo André

Country

Brazil

Facility Name

Fundação Faculdade Regional de Medicina de São José do Rio Preto

City

São José Do Rio Preto

Country

Brazil

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

The First Affiliated Hospital of Bengbu Medical College

City

Bengbu

ZIP/Postal Code

233004

Country

China

Facility Name

The First Hospital of Jilin University

City

Changchun

ZIP/Postal Code

450008

Country

China

Facility Name

West China Hospital, Sichuan University

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Tongji Hospital

City

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

Linyi Cancer Hospital

City

Linyi

Country

China

Facility Name

Henan Cancer Hospital

City

Zhengzhou

Country

China

Facility Name

CHU Brest - Hôpital Morvan

City

Brest

Country

France

Facility Name

Hôpital Nord - CHU Marseille

City

Marseille

Country

France

Facility Name

Institut de Cancérologie de la Loire

City

Saint-Priest-en-Jarez

Country

France

Facility Name

Centre Hospitalier de Saint-Quentin

City

Saint-Quentin

ZIP/Postal Code

02321

Country

France

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Evangelisches Krankenhaus Hamm GmbH

City

Hamm

ZIP/Postal Code

50063

Country

Germany

Facility Name

Universitaetsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Pius-Hospital Oldenburg

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Facility Name

Semmelweis Egyetem

City

Budapest

Country

Hungary

Facility Name

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

City

Gyula

Country

Hungary

Facility Name

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

City

Szolnok

Country

Hungary

Facility Name

Tudogyogyintezet Torokbalint

City

Törökbálint

Country

Hungary

Facility Name

Zala Megyei Szent Rafael Korhaz

City

Zalaegerszeg

Country

Hungary

Facility Name

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

City

Meldola

Country

Italy

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori

City

Milano

Country

Italy

Facility Name

Azienda Sanitaria Universitaria Integrata di Udine

City

Udine

Country

Italy

Facility Name

Chungbuk National University Hospital

City

Cheongju-si

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, St. Vincent's Hospital

City

Suwon

Country

Korea, Republic of

Facility Name

KO-MED Centra Kliniczne Biala Podlaska

City

Biała Podlaska

Country

Poland

Facility Name

Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

City

Gdynia

Country

Poland

Facility Name

SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

City

Olsztyn

Country

Poland

Facility Name

Przychodnia Med-Polonia Sp. z o.o.

City

Poznań

Country

Poland

Facility Name

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

City

Poznań

Country

Poland

Facility Name

S.C Gral Medical S.R.L

City

Bucuresti

Country

Romania

Facility Name

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

City

Cluj-Napoca

Country

Romania

Facility Name

S.C Medisprof S.R.L

City

Cluj-Napoca

Country

Romania

Facility Name

S.C Centrul de Oncologie Sf. Nectarie S.R.L

City

Craiova

Country

Romania

Facility Name

S.C Radiotherapy Center Cluj S.R.L

City

Floreşti

Country

Romania

Facility Name

Oncomed SRL

City

Timişoara

Country

Romania

Facility Name

SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

City

Arkhangel'sk

Country

Russian Federation

Facility Name

"VitaMed" LLC

City

Moscow

Country

Russian Federation

Facility Name

BHI of Omsk region "Clinical Oncology Dispensary"

City

Omsk

Country

Russian Federation

Facility Name

SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

SPb SBIH "City Clinical Oncological Dispensary"

City

Saint Petersburg

Country

Russian Federation

Facility Name

SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

City

Yaroslavl

Country

Russian Federation

Facility Name

Clinical Center "Bezanijska kosa"

City

Belgrade

Country

Serbia

Facility Name

Oncomed System

City

Belgrade

Country

Serbia

Facility Name

Clinical Center Kragujevac

City

Belgrad

Country

Serbia

Facility Name

Institute for Pulmonary Diseases of Vojvodina

City

Sremska Kamenica

Country

Serbia

Facility Name

General Hospital Uzice

City

Užice

ZIP/Postal Code

31000

Country

Serbia

Facility Name

ICO l'Hospitalet - Hospital Duran i Reynals

City

L'Hospitalet De Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital General Universitario de Alicante

City

Alicante

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

Country

Spain

Facility Name

Hospital Regional Universitario de Malaga

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Changhua Christian Hospital

City

Changhua

Country

Taiwan

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Tri-Service General Hospital

City

Taipei

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital, Linkou

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Baskent University Adana Application and Research Center

City

Adana

Country

Turkey

Facility Name

Trakya University Medical Faculty

City

Edirne

Country

Turkey

Facility Name

Istanbul Medeniyet Uni Goztepe Training&Res Hosp

City

Istanbul

Country

Turkey

Facility Name

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

City

Istanbul

Country

Turkey

Facility Name

Inonu Uni. Med. Fac.

City

Malatya

Country

Turkey

Facility Name

Namik Kemal University

City

Tekirdağ

Country

Turkey

Facility Name

CI Chernivtsi RC Oncological Dispensary

City

Chernivtsi

Country

Ukraine

Facility Name

CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

City

Dnipro

Country

Ukraine

Facility Name

Communal Non-profit Enterprise Regional Center of Oncology

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council

City

Kremenchuk

ZIP/Postal Code

39617

Country

Ukraine

Facility Name

CI Kryvyi Rih Oncological Dispensary of DRC

City

Kryvyi Rih

Country

Ukraine

Facility Name

Treatment-Prevention Institution Volyn Regional Oncological Dispensary

City

Luts'k

Country

Ukraine

Facility Name

Odesa Regional Oncologic Dispensary

City

Odesa

Country

Ukraine

Facility Name

RCI Sumy Regional Clinical Oncological Dispensary

City

Sumy

Country

Ukraine

Facility Name

CCCH City Oncological Center SHEI Uzhgorod NU

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Medical Clinic Innovacia, LLC

City

Vyshhorod

ZIP/Postal Code

07352

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

35195913

Citation

Paz-Ares L, Spigel DR, Chen Y, Jove M, Juan-Vidal O, Rich P, Hayes T, Calderon VG, Caro RB, Navarro A, Dowlati A, Zhang B, Moore Y, Yao X, Kokhreidze J, Ponce S, Bunn PA. RESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer. Cancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23.

Results Reference

derived

Learn more about this trial

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

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