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Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dinutuximab
Irinotecan
Topotecan
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Dinutuximab, Irinotecan, Topotecan

Eligibility Criteria

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

Inclusion Criteria:

  1. Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin).
  2. Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
  3. Have no curative therapy available.
  4. Have a life expectancy of at least 12 weeks.
  5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Have adequate bone marrow and hepatic function.
  7. Have calculated creatinine clearance (CrCL) ≥30 mL/minute or serum creatinine ≤1.5 times below the upper limit of normal.
  8. Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment.
  9. Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.

Exclusion Criteria:

  1. Candidate for re-treatment with original platinum-based regimen as second-line therapy.
  2. Prior treatment with irinotecan, topotecan, or dinutuximab.
  3. Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation.
  4. Have mixed small cell and non-small cell histologic features.
  5. Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical 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.
  6. Have a history or current evidence of uncontrolled cardiovascular disease.
  7. Have not recovered from prior surgery, significant trauma, systemic anticancer therapy, radiation therapy or investigational therapy to Grade 1 or better toxicity prior to enrollment (Part 1) or randomization (Part 2).
  8. Have had organ allograft or hematopoietic transplantation.
  9. Known to be human immunodeficiency virus (HIV) positive.
  10. Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion.
  11. Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2).
  12. Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
  13. Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.

Sites / Locations

  • Alaska Clinical Research Center
  • Cancer Treatment Centers of America - Western Regional Medical Center
  • Innovative Clinical Research Institute
  • Genesis Cancer Center
  • USC Norris Comprehensive Cancer Center
  • VA Palo Alto Health Care System
  • Olive View - UCLA
  • Innovative Clinical Research Institute
  • Hartford Hospital
  • Eastern Connecticut Hematology and Oncology Assoc
  • Alpha Oncology Research LLC
  • 21st Century Oncology
  • Comprehensive Hematology Oncology
  • Winship Cancer Institute, Emory University
  • Northwest Georgia Oncology Centers, P.C.
  • Baptist Health Floyd Cancer Center
  • Physicians' Clinic of Iowa Hematology and Oncology
  • Kentucky Cancer Clinic
  • University of Kentucky
  • 21st Century Oncology
  • Cox Health Medical
  • Billings Clinic Cancer Center
  • St. Vincent Frontier Cancer Center
  • The University of New Mexico Comprehensive Cancer Center
  • UH Cleveland Medical Center
  • Cancer Treatment Centers of America at Southwestern RMC
  • Kaiser Permanente Northwest Center for Health Research CRSS
  • Fox Chase Cancer Center Office of Clinical Research
  • Cancer Treatment Centers of America at Eastern Regional Medical Center
  • Charleston Oncology
  • Spartanburg Medical Center/Gibbs Cancer Center and Research Institute
  • Prairie Lakes Health Care
  • Center for Biomedical Research
  • Texas Health Physicians Group
  • Plano Cancer Institute
  • The University of Texas Health Science Center at Tyler, Office of Clinical Studies
  • Vista Oncology (Shelton office)
  • United Hospital Center
  • Camden Clark Medical Center / Regional Cancer Center
  • University of Wisoncsin - Carbone Cancer Ctr
  • Mid North Coast Cancer Institute Coff Habour Health Campus
  • Mater Misericordiae Limited and Mater Medical Research Institute Limited
  • Royal Adelaide Hospital
  • Ballarat Health Services
  • Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad
  • Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas
  • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
  • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo
  • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte
  • Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven
  • Clinic of Oncology, UMHAT Pulmed
  • First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD
  • First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia
  • Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia
  • Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia
  • Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia
  • Clinic of Oncology, UMHAT SofiaMed
  • Clinic of Oncology, MHAT Sveta Marina
  • Cross Cancer Institute - Clinical Trials Unit
  • Horizon Health Network - The Moncton Hosoital
  • Princess Margaret Cancer Centre
  • Windsor Regional Hospital Cancer Program
  • McGill University Health Center
  • L'Institut Universitaire de Cardiologie et de pneumologie de Quebec
  • Hopital Nord
  • Institut Regional du Cancer de Montpellier
  • Institut de Cancérologie de l'Ouest - Centre Paul Papin
  • Clinique Victor Hugo
  • URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
  • URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
  • Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud
  • CHU Brest
  • Centre François Baclesse
  • CHI Créteil
  • Institut Paoli-Calmettes, Service Dòncologie Médicale
  • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Centre Paul Strauss
  • Nouvel Hôpital Civil de Strasbourg
  • LTD High Technology Hospital Medcenter
  • LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''
  • High Technology Medical Center, University Clinic
  • Institute of Clinical Oncology
  • Multiprofile Clinic Consillium Medulla
  • Princess Margaret Hospital
  • Queen Elizabeth Hospital
  • Queen Mary Hospital
  • Hetenyi Geza Hospital
  • Koranyi National Institute of Pulmonology - Horváth
  • Koranyi National Institute of TBC and Pulmonology
  • Korányi National Institute
  • Semmelweis Egyetem AOK Pulmonologiai Klinika
  • Veszprém Megyei Tüdőgyógyintézet
  • Matrai Gyogyintezet
  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály
  • Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
  • Tudogyogyintezet Torokbalint
  • Zala Megyei Szent Rafael Korhaz
  • Sri Venkateshwara Hospitals
  • KLES Dr Prabhakar Kore Hospital & MRC
  • Jaslok Hospital & Research Center
  • Deenanath Mangeshkar Hospital
  • Grant Medical Foundation Ruby Hall Clinic
  • Birla Cancer Centre, SMS Hospital
  • Healthcare Global (HCG) Towers
  • Bhagawan Mahaveer Cancer Hospital
  • Dipartimento di Oncologia, ARNAS Garibaldi
  • Istituto Nazionale dei Tumori
  • Istituto Europeo di Oncologia (IEO), Milano
  • Ospedale Santa Maria della Misericordia, Perugia
  • Radiation Oncology, Campus Bio-Medico University
  • Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena
  • A.O.U. San Luigi Gonzaga, Orbassano (Torino)
  • Kosin University Gospel Hospital
  • Chungbuk National University Hospital
  • Kyungpook National University Medical Center
  • Kyungpook University Chilgok Hospital
  • Keimyung University Dongsan Medical Centre
  • Chungnam National University Hospital
  • CHA Bundang Medical Center
  • Seoul National University Bundang Hospital
  • Pusan National University Yangsan Hospital
  • Inha University Hospital
  • Chonnam National University Hwasun Hospital
  • Gachon Universtiy Gil Medical Center
  • Korea University Anam Hospital
  • Seoul National University Boramae Medical Center
  • Ulsan University Hospital
  • Wonju Severance Christian Hospital
  • Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos
  • National Cancer Institute
  • Vilnius University Hospital Santaros Klinikos
  • Hospital Kuala Lumpur
  • Department of Medicine, Faculty of Medicine
  • Hospital Umum Sarawak
  • National Cancer Institute
  • Cebu Doctors University Hospital
  • Davao Doctors Hospital
  • Manila Doctors Hospital
  • St. Luke's Medical Center - Quezon City
  • St. Luke's Medical Centre
  • Szpital Specjalistyczny w Prabutach Sp. z o.o
  • Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie
  • Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Szpital Chorób Płuc im Św. Józefa w Pilchowicach
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
  • Centrum Onkologii-Instytut im. Sklodowskiej-Curie
  • Wojskowy Instytut Medyczny
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • Oncopremium Team LTD
  • Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca
  • Medisprof LTD
  • SC Oncolab LTD
  • SC Oncology Center Sf. Nectarie LTD
  • Emergency County Hospital Satu-Mare, Medical Oncology Clinic
  • Emergency Hospital ,Sf. Ioan cel Nou'
  • Oncocenter Oncology Clinic LTD
  • State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
  • State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary
  • Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region
  • Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation
  • State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department
  • State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"
  • State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1
  • State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary
  • Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary
  • State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary
  • Center of Palliative Care-Devita LLC
  • State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital
  • BioEq, LLC
  • Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov
  • State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)
  • Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
  • State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary
  • State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital
  • St. Jacob´s Hospital Bardejov - Department of Clinical Oncology
  • Faculty Hospital Zilina
  • Hospital General Universitario de Elche
  • Hospital Universitario Marqués de Valdecilla
  • CHU A Coruña
  • Hospital Universitario Puerta de Hierro
  • Complejo Hospitalario de Navarra
  • Hospital General de Alicante
  • Hospital Quirón Dexeus
  • Hospital Universitari Vall d´Hebron
  • Hospital Universitario Reina Sofia
  • Instituto Catalán de Oncología (ICO) - Josep Trueta
  • Hospital Universitario Lucus Augusti
  • Hospital General Universitário Gregorio Marañón
  • Hospital Universitario La Paz
  • Hospital Universitario Madrid Norte Sanchinarro
  • H. M. Puerta del Sur (H. Móstoles)
  • Hospital Regional de Málaga (H. Carlos Haya)
  • Complexo Hospitalario Universitario de Ourense (CHUO)
  • Hospital Virgen de los Lirios Alcoy
  • Corporació Sanitària Parc Taulí
  • Hospital Universitario Virgen de Valme
  • Hospital Universitario y Politécnico de La Fe
  • Hospital Álvaro Cunqueiro
  • Hospital Lozano Blesa
  • E-Da Hospital
  • E-Da Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Chung Shan Medical University Hospital
  • Chi Mei Hospital, Liouying
  • Chang-Gung Memorial Hospital, Linkou
  • King Chulalongkorn Memorial Hospital
  • National Cancer Institute of Thailand
  • Siriraj Hopsital
  • Maharaj Nakorn Chiang Mai Hospital
  • Srinagarind Hospital
  • Naresuan University Hospital
  • Songklanagarind Hospital
  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council," Municipal Institution "Multifield Dnipropetrovsk City Hospital #4" of Dnipropetrovsk Regional Council, Department of Chemotherapy
  • Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre
  • Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology
  • Communal Non-profit Enterprise "Kyiv City Clinical Oncology Center" of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients
  • Municipal Nonprofit Institution "Odessa Regional Oncology Dispensary" of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department)
  • Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy
  • Princess Alexandra Hospital
  • Royal Marsden Hospital
  • St James' Institute of Oncology
  • St Bartholomew's Hospital
  • Royal Free Hospital
  • Guy's and St Thomas' NHS Foundation Trust
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Part 1: Dinutuximab + Irinotecan

Part 2: Irinotecan

Part 2: Dinutuximab + Irinotecan

Part 2: Topotecan

Arm Description

Dinutuximab (10 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.

Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.

Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.

Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS will be derived as: (date of death - date of randomization) + 1. Subjects who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the subject was known to be alive.

Secondary Outcome Measures

Progression-free Survival (PFS)
PFS will be defined as the time from the date of randomization to the date of first documentation of tumor progression or death from any cause, whichever occurs first.
Objective Response Rate (ORR)
The ORR is the percentage of subjects with best overall response of either complete response (CR) or partial response (PR); ORR = CR + PR. Per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters as confirmed by CT or MRI.
Clinical Benefit Rate (CBR)
The CBR is defined as the percentage of subjects with either a CR, PR, or stable disease (SD), relative to the number of subjects in the treatment group. Per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study, as confirmed by CT or MRI .

Full Information

First Posted
March 22, 2017
Last Updated
November 12, 2020
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03098030
Brief Title
Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
Official Title
A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 27, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Dinutuximab, Irinotecan, Topotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
483 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dinutuximab + Irinotecan
Arm Type
Experimental
Arm Description
Dinutuximab (10 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.
Arm Title
Part 2: Irinotecan
Arm Type
Active Comparator
Arm Description
Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.
Arm Title
Part 2: Dinutuximab + Irinotecan
Arm Type
Experimental
Arm Description
Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.
Arm Title
Part 2: Topotecan
Arm Type
Active Comparator
Arm Description
Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.
Intervention Type
Biological
Intervention Name(s)
Dinutuximab
Other Intervention Name(s)
Unituxin®, ch14.18
Intervention Description
Dinutuximab injection, for intravenous (IV) use
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar®
Intervention Description
Irinotecan injection, IV infusion
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin®
Intervention Description
Topotecan for injection
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS will be derived as: (date of death - date of randomization) + 1. Subjects who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the subject was known to be alive.
Time Frame
Up to approximately 2.5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS will be defined as the time from the date of randomization to the date of first documentation of tumor progression or death from any cause, whichever occurs first.
Time Frame
Up to approximately 2.5 years
Title
Objective Response Rate (ORR)
Description
The ORR is the percentage of subjects with best overall response of either complete response (CR) or partial response (PR); ORR = CR + PR. Per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters as confirmed by CT or MRI.
Time Frame
Up to approximately 2.5 years
Title
Clinical Benefit Rate (CBR)
Description
The CBR is defined as the percentage of subjects with either a CR, PR, or stable disease (SD), relative to the number of subjects in the treatment group. Per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study, as confirmed by CT or MRI .
Time Frame
Up to approximately 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin). Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible). Have no curative therapy available. Have a life expectancy of at least 12 weeks. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Have adequate bone marrow and hepatic function. Have calculated creatinine clearance (CrCL) ≥30 mL/minute or serum creatinine ≤1.5 times below the upper limit of normal. Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment. Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration. Exclusion Criteria: Candidate for re-treatment with original platinum-based regimen as second-line therapy. Prior treatment with irinotecan, topotecan, or dinutuximab. Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation. Have mixed small cell and non-small cell histologic features. Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical 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. Have a history or current evidence of uncontrolled cardiovascular disease. Have not recovered from prior surgery, significant trauma, systemic anticancer therapy, radiation therapy or investigational therapy to Grade 1 or better toxicity prior to enrollment (Part 1) or randomization (Part 2). Have had organ allograft or hematopoietic transplantation. Known to be human immunodeficiency virus (HIV) positive. Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion. Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2). Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2). Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.
Facility Information:
Facility Name
Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Cancer Treatment Centers of America - Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Olive View - UCLA
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology Assoc
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Alpha Oncology Research LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
21st Century Oncology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Comprehensive Hematology Oncology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Baptist Health Floyd Cancer Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Physicians' Clinic of Iowa Hematology and Oncology
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
21st Century Oncology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Cox Health Medical
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
The University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
UH Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cancer Treatment Centers of America at Southwestern RMC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Kaiser Permanente Northwest Center for Health Research CRSS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Fox Chase Cancer Center Office of Clinical Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Cancer Treatment Centers of America at Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Charleston Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Spartanburg Medical Center/Gibbs Cancer Center and Research Institute
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Prairie Lakes Health Care
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Center for Biomedical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Health Physicians Group
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Plano Cancer Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
The University of Texas Health Science Center at Tyler, Office of Clinical Studies
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Vista Oncology (Shelton office)
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Facility Name
United Hospital Center
City
Bridgeport
State/Province
West Virginia
ZIP/Postal Code
26330
Country
United States
Facility Name
Camden Clark Medical Center / Regional Cancer Center
City
Parkersburg
State/Province
West Virginia
ZIP/Postal Code
26101
Country
United States
Facility Name
University of Wisoncsin - Carbone Cancer Ctr
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Mid North Coast Cancer Institute Coff Habour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
NSW 2450
Country
Australia
Facility Name
Mater Misericordiae Limited and Mater Medical Research Institute Limited
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
QLD 4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ballarat Health Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Facility Name
Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Clinic of Oncology, UMHAT Pulmed
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Clinic of Oncology, UMHAT SofiaMed
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Clinic of Oncology, MHAT Sveta Marina
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Cross Cancer Institute - Clinical Trials Unit
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Horizon Health Network - The Moncton Hosoital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Windsor Regional Hospital Cancer Program
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
L'Institut Universitaire de Cardiologie et de pneumologie de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hopital Nord
City
Marseille
State/Province
Alpes-Côte d'Azur
ZIP/Postal Code
13915
Country
France
Facility Name
Institut Regional du Cancer de Montpellier
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34298
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Centre Paul Papin
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49055
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
State/Province
Pays De La Loire
ZIP/Postal Code
72000
Country
France
Facility Name
URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
City
Bron
State/Province
Rhône-Alpes
ZIP/Postal Code
69677
Country
France
Facility Name
URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
City
Lyon
State/Province
Rhône-Alpes
ZIP/Postal Code
69004
Country
France
Facility Name
Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud
City
Pierre Bénite
State/Province
Rhône-Alpes
ZIP/Postal Code
69945
Country
France
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHI Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Institut Paoli-Calmettes, Service Dòncologie Médicale
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Nouvel Hôpital Civil de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
LTD High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Facility Name
LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
High Technology Medical Center, University Clinic
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Institute of Clinical Oncology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Multiprofile Clinic Consillium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Princess Margaret Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Pokfulam
Country
Hong Kong
Facility Name
Hetenyi Geza Hospital
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Koranyi National Institute of Pulmonology - Horváth
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Koranyi National Institute of TBC and Pulmonology
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Korányi National Institute
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Semmelweis Egyetem AOK Pulmonologiai Klinika
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Veszprém Megyei Tüdőgyógyintézet
City
Farkasgyepű
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Matrai Gyogyintezet
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Sri Venkateshwara Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560076
Country
India
Facility Name
KLES Dr Prabhakar Kore Hospital & MRC
City
Nehru Nagar
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Jaslok Hospital & Research Center
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
Deenanath Mangeshkar Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Grant Medical Foundation Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Birla Cancer Centre, SMS Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Healthcare Global (HCG) Towers
City
Bangalore
ZIP/Postal Code
560020
Country
India
Facility Name
Bhagawan Mahaveer Cancer Hospital
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
Dipartimento di Oncologia, ARNAS Garibaldi
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
Istituto Europeo di Oncologia (IEO), Milano
City
Milan
Country
Italy
Facility Name
Ospedale Santa Maria della Misericordia, Perugia
City
Perugia
Country
Italy
Facility Name
Radiation Oncology, Campus Bio-Medico University
City
Rome
ZIP/Postal Code
I-00128
Country
Italy
Facility Name
Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena
City
Siena
ZIP/Postal Code
I-53100
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga, Orbassano (Torino)
City
Torino
Country
Italy
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Kyungpook University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Centre
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeonnam
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Gachon Universtiy Gil Medical Center
City
Namdong
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju-Si, Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Department of Medicine, Faculty of Medicine
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Umum Sarawak
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
National Cancer Institute
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Cebu Doctors University Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
St. Luke's Medical Center - Quezon City
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
St. Luke's Medical Centre
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Szpital Specjalistyczny w Prabutach Sp. z o.o
City
Prabuty
State/Province
Pomeranian Voivodeship
ZIP/Postal Code
82-550
Country
Poland
Facility Name
Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie
City
Olsztyn
State/Province
Warminsko-Mazurskie
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina
City
Mrozy
ZIP/Postal Code
05-320
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Szpital Chorób Płuc im Św. Józefa w Pilchowicach
City
Pilchowice
ZIP/Postal Code
44-145
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
City
Łódź
State/Province
Łódź Voivodeship
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Oncopremium Team LTD
City
Baia-Mare
ZIP/Postal Code
430291
Country
Romania
Facility Name
Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Medisprof LTD
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
SC Oncolab LTD
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
SC Oncology Center Sf. Nectarie LTD
City
Craiova
Country
Romania
Facility Name
Emergency County Hospital Satu-Mare, Medical Oncology Clinic
City
Satu-Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Emergency Hospital ,Sf. Ioan cel Nou'
City
Suceava
ZIP/Postal Code
720224
Country
Romania
Facility Name
Oncocenter Oncology Clinic LTD
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region
City
Kursk
ZIP/Postal Code
305524
Country
Russian Federation
Facility Name
Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"
City
Moscow
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary
City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Center of Palliative Care-Devita LLC
City
Saint Petersburg
ZIP/Postal Code
197183
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
BioEq, LLC
City
Saint-Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Facility Name
Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
St. Jacob´s Hospital Bardejov - Department of Clinical Oncology
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Faculty Hospital Zilina
City
Žilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
CHU A Coruña
City
Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Quirón Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitari Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Instituto Catalán de Oncología (ICO) - Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital General Universitário Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
H. M. Puerta del Sur (H. Móstoles)
City
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hospital Regional de Málaga (H. Carlos Haya)
City
Málaga
ZIP/Postal Code
29006
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Ourense (CHUO)
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital Virgen de los Lirios Alcoy
City
Planta
ZIP/Postal Code
03804
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario y Politécnico de La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
E-Da Hospital
City
Kaohsiung City
ZIP/Postal Code
42445
Country
Taiwan
Facility Name
E-Da Hospital
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Chi Mei Hospital, Liouying
City
Tainan City
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
National Cancer Institute of Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hopsital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Naresuan University Hospital
City
Phitsanulok
ZIP/Postal Code
65000
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council," Municipal Institution "Multifield Dnipropetrovsk City Hospital #4" of Dnipropetrovsk Regional Council, Department of Chemotherapy
City
Dnipro
State/Province
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre
City
Uzhgorod
State/Province
Zakarpattia
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Communal Non-profit Enterprise "Kyiv City Clinical Oncology Center" of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Municipal Nonprofit Institution "Odessa Regional Oncology Dispensary" of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department)
City
Odessa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy
City
Vinnitsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Princess Alexandra Hospital
City
Harlow
State/Province
Essex
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Chelsea
State/Province
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
St James' Institute of Oncology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35278766
Citation
Edelman MJ, Dvorkin M, Laktionov K, Navarro A, Juan-Vidal O, Kozlov V, Golden G, Jordan O, Deng CQ, Bentsion D, Chouaid C, Dechev H, Dowlati A, Fernandez Nunez N, Ivashchuk O, Kiladze I, Kortua T, Leighl N, Luft A, Makharadze T, Min Y, Quantin X; DISTINCT study investigators. Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer. Lung Cancer. 2022 Apr;166:135-142. doi: 10.1016/j.lungcan.2022.03.003. Epub 2022 Mar 4.
Results Reference
derived

Learn more about this trial

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

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