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

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 was conducted in two parts:

1. Dose determination of irinotecan liposome injection
2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Irinotecan liposome injection; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Wollongong, Australia
    • Southern Medical Day Care Centre
  • Woolloongabba, Australia
    • Princess Alexandra Hospital
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Border Medical Oncology Research Unit
  • Victoria
    • Warrnambool, Victoria, Australia, 3280
      • South West Healthcare
• Belgium
  • Brasschaat, Belgium
    • AZ Klina
  • Leuven, Belgium
    • UZ Leuven
  • Libramont, Belgium
    • Centre Hospitalier de l'Ardenne
  • Mechelen, Belgium
    • Az Sint-Maarten
• Brazil
  • Barretos, Brazil
    • Hospital de Cancer de Barretos, Fundacoa Pio X II
  • Ijuí, Brazil
    • Hospital de Caridade de Ijui
  • Nova Lima, Brazil
    • Oncobio Servicos de Saude
  • Porto Alegre, Brazil
    • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Porto Alegre, Brazil
    • Hospital Nossa Senhora da Conceicao
  • Rio De Janeiro, Brazil
    • INCA - Instituto Nacional de Cancer
  • Santo André, Brazil
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • São José Do Rio Preto, Brazil
    • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Bengbu, China, 233004
    • The First Affiliated Hospital of Bengbu Medical College
  • Changchun, China, 450008
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hubei, China, 430030
    • Tongji Hospital
  • Linyi, China
    • Linyi Cancer Hospital
  • Zhengzhou, China
    • Henan cancer hospital
• France
  • Brest, France
    • Chu Brest - Hôpital Morvan
  • Marseille, France
    • Hôpital Nord - CHU Marseille
  • Saint-Priest-en-Jarez, France
    • Institut de Cancerologie de La Loire
  • Saint-Quentin, France, 02321
    • Centre Hospitalier de Saint-Quentin
• Germany
  • Freiburg, Germany, 79106
    • Universitaetsklinikum Freiburg
  • Hamm, Germany, 50063
    • Evangelisches Krankenhaus Hamm GmbH
  • Heidelberg, Germany, 69126
    • Universitaetsklinikum Heidelberg
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem
  • Gyula, Hungary
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Szolnok, Hungary
    • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
  • Törökbálint, Hungary
    • Tudogyogyintezet Torokbalint
  • Zalaegerszeg, Hungary
    • Zala Megyei Szent Rafael Korhaz
• Italy
  • Meldola, Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milano, Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Udine, Italy
    • Azienda Sanitaria Universitaria Integrata di Udine
• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Chungbuk National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Suwon, Korea, Republic of
    • The Catholic university of Korea, St. Vincent's Hospital
• Poland
  • Biała Podlaska, Poland
    • KO-MED Centra Kliniczne Biala Podlaska
  • Gdynia, Poland
    • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
  • Olsztyn, Poland
    • SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
  • Poznań, Poland
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  • Poznań, Poland
    • Przychodnia Med-Polonia Sp. z o.o.
• Romania
  • Bucuresti, Romania
    • S.C Gral Medical S.R.L
  • Cluj-Napoca, Romania
    • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  • Cluj-Napoca, Romania
    • S.C Medisprof S.R.L
  • Craiova, Romania
    • S.C Centrul de Oncologie Sf. Nectarie S.R.L
  • Floreşti, Romania
    • S.C Radiotherapy Center Cluj S.R.L
  • Timişoara, Romania
    • Oncomed Srl
• Russian Federation
  • Arkhangel'sk, Russian Federation
    • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
  • Moscow, Russian Federation
    • "VitaMed" LLC
  • Omsk, Russian Federation
    • BHI of Omsk region "Clinical oncology dispensary"
  • Saint Petersburg, Russian Federation, 197022
    • SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"
  • Saint Petersburg, Russian Federation
    • SPb SBIH "City Clinical Oncological Dispensary"
  • Yaroslavl, Russian Federation
    • SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
• Serbia
  • Belgrad, Serbia
    • Clinical Center Kragujevac
  • Belgrade, Serbia
    • Clinical Center "Bezanijska kosa"
  • Belgrade, Serbia
    • Oncomed System
  • Sremska Kamenica, Serbia
    • Institute For Pulmonary Diseases of Vojvodina
  • Užice, Serbia, 31000
    • General Hospital Uzice
• Spain
  • Alicante, Spain
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46026
    • Hospital Universitari I Politecnic La Fe
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
      • Ico L'Hospitalet - Hospital Duran I Reynals
• Taiwan
  • Changhua, Taiwan
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
• Turkey
  • Adana, Turkey
    • Baskent University Adana Application and Research Center
  • Edirne, Turkey
    • Trakya University Medical Faculty
  • Istanbul, Turkey
    • Istanbul Medeniyet Uni Goztepe Training&Res Hosp
  • Istanbul, Turkey
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Malatya, Turkey
    • Inonu Uni. Med. Fac.
  • Tekirdağ, Turkey
    • Namik Kemal University
• Ukraine
  • Chernivtsi, Ukraine
    • CI Chernivtsi RC Oncological Dispensary
  • Dnipro, Ukraine
    • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
  • Kharkiv, Ukraine, 61070
    • Communal Non-profit Enterprise Regional Center of Oncology
  • Kremenchuk, Ukraine, 39617
    • Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council
  • Kryvyi Rih, Ukraine
    • CI Kryvyi Rih Oncological Dispensary of DRC
  • Luts'k, Ukraine
    • Treatment-Prevention Institution Volyn Regional Oncological Dispensary
  • Odesa, Ukraine
    • Odesa Regional Oncologic Dispensary
  • Sumy, Ukraine
    • RCI Sumy Regional Clinical Oncological Dispensary
  • Uzhgorod, Ukraine, 88000
    • CCCH City Oncological Center SHEI Uzhgorod NU
  • Vyshhorod, Ukraine, 07352
    • Medical Clinic Innovacia, LLC
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists (South Region)
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers
    • Newnan, Georgia, United States, 30265
      • Cancer Treatment Centers of America-Georgia
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care, PC
  • Maine
    • Biddeford, Maine, United States, 04005
      • Southern Maine Health Care
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Group
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers of Western Michigan
    • Lansing, Michigan, United States, 48219
      • Sparrow Regional Cancer Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • East Setauket, New York, United States, 11733
      • North Shore Hematology Oncology Associates, PC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Massillon, Ohio, United States, 44646
      • Tri County Hematology & Oncology Associates, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Washington
    • Spokane, Washington, United States, 99204
      • MultiCare Health System Institute for Research and Innovation
    • Spokane, Washington, United States, 99208
      • Summit Cancer Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Experimental Arm, dose level 1; Irinotecan liposome injection	Drug: Irinotecan liposome injection; IV; Other Names: ONIVYDE®
Experimental: Part 1: Experimental Arm, dose level 2; Irinotecan liposome injection	Drug: Irinotecan liposome injection; IV; Other Names: ONIVYDE®
Experimental: Part 2: Experimental Arm; Irinotecan liposome injection	Drug: Irinotecan liposome injection; IV; Other Names: ONIVYDE®
Active Comparator: Part 2: Control Arm; Topotecan	Drug: Topotecan; IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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.	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
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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.	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
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.	From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days)
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.	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 900 days
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.	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
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.	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
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.	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
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.	Baseline (Day 1) and Week 12
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.	Baseline (Day 1) and Week 12

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan; Topotecan
• Other Study ID Numbers: MM-398-01-03-04; 2017-004261-26 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No