Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03088813




Registration number
NCT03088813
Ethics application status
Date submitted
9/03/2017
Date registered
23/03/2017
Date last updated
29/04/2019

Titles & IDs
Public title
Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
MM-398-01-03-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Irinotecan liposome injection
Treatment: Drugs - Topotecan

Experimental: Experimental Arm - Irinotecan liposome injection

Active Comparator: Control Arm - Topotecan


Treatment: Drugs: Irinotecan liposome injection
IV

Treatment: Drugs: Topotecan
IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) - Overall survival is defined as the time from randomization to date of death. The primary hypothesis will test whether OS is increased in patients treated with irinotecan liposome injection
Timepoint [1] 0 0
40 months
Secondary outcome [1] 0 0
Progression-free survival - Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first
Timepoint [1] 0 0
40 months
Secondary outcome [2] 0 0
Objective Response - Objective response is defined as the time from randomization to date of progression or death. Objective response rate (ORR) is the proportion of patients who achieve partial response or complete response according to RECIST v1.1 guidelines
Timepoint [2] 0 0
40 months
Secondary outcome [3] 0 0
Proportion of Patients with Symptom Improvement - Patient-reported EORTC-QLQ symptom scales for cough, dyspnea, and fatigue
Timepoint [3] 0 0
Randomization to 30 Days after permanent treatment termination
Secondary outcome [4] 0 0
Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities - Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any study drug.
Timepoint [4] 0 0
Enrollment to 30 days after permanent treatment termination

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [3] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maine
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
France
State/province [12] 0 0
Calvados
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Saint-Quentin
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Hamm
Country [18] 0 0
Germany
State/province [18] 0 0
Heidelberg
Country [19] 0 0
Germany
State/province [19] 0 0
Muenchen
Country [20] 0 0
Germany
State/province [20] 0 0
Oldenburg
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
Málaga
Country [24] 0 0
Spain
State/province [24] 0 0
Sevilla
Country [25] 0 0
Spain
State/province [25] 0 0
Valencia
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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 will be conducted in two parts:

1. Dose determination of irinotecan liposome injection

2. A randomized, efficacy study of irinotecan liposome injection versus topotecan
Trial website
https://clinicaltrials.gov/show/NCT03088813
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications