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Clinical Trials List

Protocol NumberMM-398-01-03-04
NCT Number(ClinicalTrials.gov Identfier)NCT03088813

2018-06-01 - 2022-09-30

Phase III

Recruiting5

ICD-10C34

Malignant neoplasm of bronchus and lung

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    IPSEN BIOSCIENCE, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Ying Liu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

劉劍英

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Recruiting

Audit

None

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Small cell lung cancer

Objectives

Part 1 Primary Objectives The primary objectives of Part 1 are: • Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks • To determine the irinotecan liposome injection monotherapy dose (85 mg/m2 or 70 mg/m2 administered every 2 weeks) for Part 2 of this study Secondary Objectives The secondary objectives of Part 1 are to assess the preliminary efficacy of irinotecan liposome injection (at either the 85 mg/m2 dose level or the 70 mg/m2 dose level) as determined by • Objective response rate (ORR) • Progression free survival (PFS) • Overall survival (OS) Part 2 Primary Objective The primary objective of Part 2 is to compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with IV topotecan. Secondary Objectives The secondary objectives of Part 2 are to compare the following between the treatment arms: • Progression free survival (PFS) • Overall response rate (ORR) • Proportion of patients with improvement in symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) • Safety profile

Test Drug

ONIVYDE

Active Ingredient

Irinotecan

Dosage Form

Injection

Dosage

4.3

Endpoints

Primary Outcome Measures :
Overall survival (OS) [ Time Frame: 40 months ]
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


Secondary Outcome Measures :
Progression-free survival [ Time Frame: 40 months ]
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

Objective Response [ Time Frame: 40 months ]
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

Proportion of Patients with Symptom Improvement [ Time Frame: Randomization to 30 Days after permanent treatment termination ]
Patient-reported EORTC-QLQ symptom scales for cough, dyspnea, and fatigue

Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities [ Time Frame: Enrollment to 30 days after permanent treatment termination ]
Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any study drug.

Inclution Criteria

Inclusion Criteria
In order for inclusion, patients must have/be:
General Inclusion Criteria
(1) At least 18 years of age.
(2) Able to understand and provide the study an informed consent
(3) ECOG performance status of 0 or 1.
(4) Life expectancy >12 weeks
Disease Specific Inclusion Criteria
(5) Histopathologically or cytologically confirmed small cell lung cancer according to the
International Association for the Study of Lung Cancer (IASLC) histopathological
classification. Mixed or combined subtypes according to the IASLC are not allowed.
(6) Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with
non-measurable lesions only are eligible).
(7) 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 SCLC.
(8) 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).
Hematologic, Biochemical and Organ Function Inclusion Criteria
(9) During the Screening period, adequate bone marrow reserves as evidenced by:
(a) Absolute neutrophil count >1,500 cells/µL (1.5 x 109
/L) without the use of
hematopoietic growth factors within the immediately preceding 14 days; and
(b) Platelet count >100,000 cells/µL (100 x 109
/L); and
(c) Hemoglobin >9 g/dL; transfusions are allowed
(10) Adequate hepatic function as evidenced by:
(a) Serum total bilirubin within normal range for the institution
(b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x
ULN (≤5 x ULN is acceptable if liver metastases are present)
(c) Serum albumin ≥3.0 g/dL (≥30 g/L)
(11) Adequate renal function as evidenced by a serum creatinine ≤1.5 x ULN and creatinine
clearance ≥40 mL/min. Actual body weight should be used for calculating creatinine
clearance using the Cockcroft-Gault Equation (except for patients with body mass index
>30 kg/m2 when lean body weight should be used instead)
(12) Electrocardiogram during the Screening period without any clinically significant
findings, per investigator’s assessment

Exclusion Criteria

Exclusion Criteria
Patients must meet all the inclusion criteria listed above and none of the following exclusion
criteria:
General Exclusion Criteria
(1) 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
(2) Pregnant or breast feeding; females of child-bearing potential must test negative for
pregnancy at the time of enrollment based on a urine or serum pregnancy test. Both male
and female patients of reproductive potential must agree to use a highly effective method
of birth control, during the study and for 4 months following the last dose of study drug.
Disease Specific Exclusion Criteria
(3) Patients with large cell neuroendocrine lung carcinoma.
(4) Patients who have received any of the following treatments:
(a) Prior treatment regimens with irinotecan, topotecan or any other topoisomerase I
inhibitor including investigational topoisomerase I inhibitors.
(b) Retreatment with the same platinum-based regimen after relapse of first-line
therapy.
(c) Any antibody-drug conjugates or molecular targeted agents (e.g. poly ADP-ribose
polymerase inhibitors), either alone or in combination with other treatments.
(d) More than one line of immunotherapy (e.g. nivolumab, pembrolizumab,
ipilimumab, atezolizumab, tremelimumab and/or durvalumab).
• One line of immunotherapy is allowed, which is defined as the following:
monotherapy or combination of immunotherapy agents given as either (i)
in combination with chemotherapy followed by immunotherapy
maintenance in the first line setting, (ii) only as a maintenance following
response to first-line chemotherapy or (iii) immunotherapy given as second
line treatment following progression.
(e) Any other additional regimen of prior cytotoxic chemotherapy, not described
above.
(5) Patients with a history of immunotherapy induced colitis or pneumonitis based on clinical
assessment and/or confirmed by biopsy.
(6) Patients with the following CNS metastasis:
(a) Patients who have developed new or progressive brain metastasis following
prophylactic and/or therapeutic cranial radiation (whole brain stereotactic
radiation).
(b) Patients with symptomatic CNS metastasis (a patient with brain metastasis who
received cranial radiotherapy is eligible if asymptomatic for neurological
symptoms for ≥2 weeks after completion of cranial radiotherapy and is off
corticosteroids for treatment of CNS metastasis. Patients with asymptomatic brain
metastases are eligible to be enrolled directly to the study).
(c) Patients with carcinomatous meningitis.
(7) 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.
(8) Have a previous or concurrent cancer that is distinct in primary (non-pulmonary) site or
SCLC histology, except carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated
>3 years ago without evidence of recurrence.
(9) 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.
Hematologic, Biochemical and Organ Function Exclusion Criteria
(10) Severe cardiovascular and pulmonary diseases (e.g. myocardial infarction, unstable
angina pectoris, coronary angioplasty or stenting, deep vein thrombosis, stroke,
pulmonary fibrosis, active uncontrolled bleeding, or a known bleeding diathesis) less
than 6 months before inclusion.
(11) New York Heart Association Class III or IV congestive heart failure, ventricular
arrhythmias, or uncontrolled blood pressure.
(12) Active infection (e.g. acute bacterial infection, tuberculosis, active hepatitis B or active
human immunodeficiency virus) which in the investigator’s opinion might compromise
the patient’s participation in the trial or affect the study outcome.
(13) Known hypersensitivity to any of the components of irinotecan liposome injection, other
liposomal products, or topotecan.
(14) Clinically significant gastrointestinal disorder including hepatic disorders, bleeding,
inflammation, occlusion, or diarrhea > grade 1.

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    486 participants

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