AzTrials
AzTrials

Small Cell Lung CancerPhase 3RESILIENTNCT03088813

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

A Phase 3 study testing Irinotecan liposome injection and Topotecan in people with Small Cell Lung Cancer, run by Ipsen at 118 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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: 1. Dose determination of irinotecan liposome injection 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Irinotecan liposome injection and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
491 participants
Where
118 sitesin 18 countries
Study dates
25 Apr 2018to 27 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

118 sites in 18 countries.

118 sites in 18 countries

United States22 sites

  • University of Maryland Medical Group

    Baltimore, Maryland, 21201

  • Southern Maine Health Care

    Biddeford, Maine, 04005

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29414

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • National Jewish Health

    Denver, Colorado, 80206

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733

  • Florida Cancer Specialists (South Region)

    Fort Myers, Florida, 33916

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Greenville Hospital System University Medical Center

    Greenville, South Carolina, 29605

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48219

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Tri County Hematology & Oncology Associates, Inc

    Massillon, Ohio, 44646

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Cancer Treatment Centers of America-Georgia

    Newnan, Georgia, 30265

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Illinois Cancer Care, PC

    Peoria, Illinois, 61615

  • MultiCare Health System Institute for Research and Innovation

    Spokane, Washington, 99204

  • Summit Cancer Treatment Center

    Spokane, Washington, 99208

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

Other trials in United States

Ukraine10 sites

  • CI Chernivtsi RC Oncological Dispensary

    Chernivtsi

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

    Dnipro

  • Communal Non-profit Enterprise Regional Center of Oncology

    Kharkiv, 61070

  • Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council

    Kremenchuk, 39617

  • CI Kryvyi Rih Oncological Dispensary of DRC

    Kryvyi Rih

  • Treatment-Prevention Institution Volyn Regional Oncological Dispensary

    Lutsk

  • Odesa Regional Oncologic Dispensary

    Odesa

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy

  • CCCH City Oncological Center SHEI Uzhgorod NU

    Uzhhorod, 88000

  • Medical Clinic Innovacia, LLC

    Vyshhorod, 07352

Other trials in Ukraine

China9 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • The First Hospital of Jilin University

    Changchun, 450008

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Tongji Hospital

    Hubei, 430030

  • Linyi Cancer Hospital

    Linyi

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

Brazil8 sites

  • Hospital de Cancer de Barretos, Fundacoa Pio X II

    Barretos

  • Hospital de Caridade de Ijuí

    Ijuí

  • Oncobio Servicos de Saude

    Nova Lima

  • HGB - Hospital Giovanni Battista - Mãe de Deus Center

    Porto Alegre

  • Hospital Nossa Senhora da Conceição

    Porto Alegre

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto

Other trials in Brazil

Spain8 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital General Universitario Gregorio Marañon

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Romania6 sites

  • S.C Gral Medical S.R.L

    Bucharest

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

    Cluj-Napoca

  • S.C Medisprof S.R.L

    Cluj-Napoca

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

    Craiova

  • S.C Radiotherapy Center Cluj S.R.L

    Floreşti

  • Oncomed SRL

    Timișoara

Other trials in Romania

Russia6 sites

  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

    Arkhangelsk

  • "VitaMed" LLC

    Moscow

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk

  • SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

    Saint Petersburg, 197022

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg

  • SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

    Yaroslavl

Other trials in Russia

Turkey (Türkiye)6 sites

  • Baskent University Adana Application and Research Center

    Adana

  • Trakya University Medical Faculty

    Edirne

  • Istanbul Medeniyet Uni Goztepe Training&Res Hosp

    Istanbul

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul

  • Inonu Uni. Med. Fac.

    Malatya

  • Namik Kemal University

    Tekirdağ

Other trials in Turkey (Türkiye)

Hungary5 sites

  • Semmelweis Egyetem

    Budapest

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Gyula

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok

  • Tudogyogyintezet Torokbalint

    Törökbálint

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg

Other trials in Hungary

Poland5 sites

  • KO-MED Centra Kliniczne Biala Podlaska

    Biała Podlaska

  • Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

    Gdynia

  • SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

    Olsztyn

  • Przychodnia Med-Polonia Sp. z o.o.

    Poznan

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan

Other trials in Poland

Serbia5 sites

  • Clinical Center "Bezanijska kosa"

    Belgrade

  • Clinical Center Kragujevac

    Belgrade

  • Oncomed System

    Belgrade

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz

  • General Hospital Uzice

    Užice, 31000

Other trials in Serbia

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • National Taiwan University Hospital

    Taipei, 100

  • Tri-Service General Hospital

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Australia4 sites

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • South West Healthcare

    Warrnambool, Victoria, 3280

  • Southern Medical Day Care Centre

    Wollongong

  • Princess Alexandra Hospital

    Woolloongabba

Other trials in Australia

Belgium4 sites

  • AZ Klina

    Brasschaat

  • UZ Leuven

    Leuven

  • Centre Hospitalier de l'Ardenne

    Libramont

  • AZ Sint-Maarten

    Mechelen

Other trials in Belgium

France4 sites

  • CHU Brest - Hôpital Morvan

    Brest

  • Hôpital Nord - CHU Marseille

    Marseille

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321

Other trials in France

Germany4 sites

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Evangelisches Krankenhaus Hamm GmbH

    Hamm, 50063

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69126

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

Other trials in Germany

South Korea4 sites

  • Chungbuk National University Hospital

    Cheongju-si

  • Asan Medical Center

    Seoul

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

    Seoul

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

    Suwon

Other trials in South Korea

Italy3 sites

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine

Other trials in Italy

About this study

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

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
Read the 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.

Being tested
Irinotecan liposome injection, Topotecan
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan liposome injectionDrug

    Also called ONIVYDE®

    IV

  • TopotecanDrug

    IV

Study groups in NCT03088813
Study groupRoleWhat they receive
Part 1: Experimental Arm, dose level 1ExperimentalIrinotecan liposome injection
Receives: Drug: Irinotecan liposome injection
Part 1: Experimental Arm, dose level 2ExperimentalIrinotecan liposome injection
Receives: Drug: Irinotecan liposome injection
Part 2: Experimental ArmExperimentalIrinotecan liposome injection
Receives: Drug: Irinotecan liposome injection
Part 2: Control ArmActive comparatorTopotecan
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 680 days

  2. 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.

    Measured: 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

  3. 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.

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

Secondary outcomes (9)

  1. 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 PD or commencement of new anti-neoplastic therapy.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

    Measured: 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

  8. 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.

    Measured: Baseline (Day 1) and Week 12

  9. 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.

    Measured: Baseline (Day 1) and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2017
  2. Study start25 Apr 2018
  3. Primary completion8 Feb 2022
  4. Study completion27 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
491 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088813
Sponsor's protocol ID
MM-398-01-03-04
Other IDs
2017-004261-26, 2017
Acronym
RESILIENT
Status last verified
Feb 2025
First submitted
9 Mar 2017
Last updated
19 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Spigel DR, Dowlati A, Chen Y, Navarro A, Yang JC, Stojanovic G, Jove M, Rich P, Andric ZG, Wu YL, Rudin CM, Chen H, Zhang L, Yeung S, Benzaghou F, Paz-Ares L, Bunn PA; RESILIENT Trial Investigators. RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 1;42(19):2317-2326. doi: 10.1200/JCO.23.02110. Epub 2024 Apr 22.

    PubMed 38648575

  • 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.

    PubMed 35195913

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan liposome injection and Topotecan in people with Small Cell Lung Cancer, run by Ipsen at 118 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Ukraine, China, Brazil, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) (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 680 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03088813, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in