Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Biological: Ipilimumab; Biological: Placebo matching Ipilimumab

• Study Type: Interventional
• Enrollment (Actual): 1351
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution
  • Ciudad Autonoma de Buenos Aires, Argentina, C1226ANZ
    • Local Institution
  • Provincia De Sante Fe, Argentina, S2000DSV
    • Local Institution
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, B1884BBF
      • Local Institution
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Local Institution
    • Wollongong, New South Wales, Australia, 2500
      • Local Institution
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Local Institution
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Local Institution
    • Wodonga, Victoria, Australia, 3690
      • Local Institution
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Local Institution
• Austria
  • Linz, Austria, 4020
    • Local Institution
  • Salzburg, Austria, 5020
    • Local Institution
  • Wien, Austria, 1130
    • Local Institution
  • Wien, Austria, 1145
    • Local Institution
• Belgium
  • Brussels, Belgium, 1090
    • Local Institution
  • Edegem, Belgium, 2650
    • Local Institution
  • Leuven, Belgium, 3000
    • Local Institution
  • Sint Niklaas, Belgium, 9100
    • Local Institution
  • Yvoir, Belgium, 5530
    • Local Institution
• Brazil
  • Passo Fundo, RS, Brazil, 99010-260
    • Local Institution
  • SP, Brazil, 12245-750
    • Local Institution
  • Sao Paulo/SP, Brazil, CEP 01246000
    • Local Institution
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • Local Institution
    • Montreal, Quebec, Canada, H2L 4M1
      • Local Institution
• Chile
  • Santiago, Chile, 8360160
    • Local Institution
  • Santiago, Chile, 8420383
    • Local Institution
  • Valparaiso
    • Vina Del Mar, Valparaiso, Chile, Region de Valparaiso, 2540364
      • Local Institution
• China
  • Beijing, China, 100032
    • Local Institution
  • Beijing, China, 100071
    • Local Institution
  • Beijing, China, 100142
    • Local Institution
  • Beijing, China, 100853
    • Local Institution
  • Shanghai, China, 200030
    • Local Institution
  • Shanghai, China, 200433
    • Local Institution
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution
    • Guangzhou, Guangdong, China, 510060
      • Local Institution
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150084
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430023
      • Local Institution
  • Jiangsu
    • Nangjing, Jiangsu, China, 210002
      • Local Institution
    • Soochow, Jiangsu, China, 215006
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130012
      • Local Institution
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Local Institution
    • Xi'an, Shaanxi, China, 710061
      • Local Institution
  • Sichuan
    • Chengdu City, Sichuan, China, 610041
      • Local Institution
  • Xinjiang
    • Urumqi, Xinjiang, China, 830011
      • Local Institution
  • Zhejiang
    • Hangzhou City, Zhejiang, China, 310009
      • Local Institution
    • Hangzhou City, Zhejiang, China
      • Local Institution
• Colombia
  • Cordoba, Colombia
    • Local Institution
• Czechia
  • Ostrava - Poruba, Czechia, 70852
    • Local Institution
  • Praha 8, Czechia, 180 81
    • Local Institution
• France
  • Caen, France, 14076
    • Local Institution
  • Rennes Cedex 9, France, 35033
    • Local Institution
  • Toulouse Cedex 9, France, 31059
    • Local Institution
  • Vandoeuvre-les-nancy, France, 54511
    • Local Institution
• Germany
  • Bad Berka, Germany, 99438
    • Local Institution
  • Bochum, Germany, 44791
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Erlangen, Germany, 91054
    • Local Institution
  • Frankfurt am Main, Germany, 60590
    • Local Institution
  • Gauting, Germany, 82131
    • Local Institution
  • Grosshansdorf, Germany, 22927
    • Local Institution
  • Hamburg, Germany, 20246
    • Local Institution
  • Heidelberg, Germany, 69126
    • Local Institution
  • Kassel, Germany, 34125
    • Local Institution
  • Mainz, Germany, 55131
    • Local Institution
  • Mannheim, Germany, 68167
    • Local Institution
  • Munchen, Germany, 81925
    • Local Institution
  • Oldenburg, Germany, 26121
    • Local Institution
  • Ulm, Germany, 89081
    • Local Institution
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution
  • Kowloon, Hong Kong
    • Local Institution
• Hungary
  • Budapest, Hungary, 1121
    • Local Institution
  • Budapest, Hungary, 1125
    • Local Institution
  • Budapest, Hungary, H-1121
    • Local Institution
  • Farkasgyepu, Hungary, 8582
    • Local Institution
  • Matrahaza, Hungary, 3233
    • Local Institution
  • Pecs, Hungary, H-7623
    • Local Institution
  • Sopron, Hungary, 9400
    • Local Institution
  • Szolnok, Hungary, H-5000
    • Local Institution
• Ireland
  • Dublin, Ireland, 4
    • Local Institution
  • Dublin, Ireland, 8
    • Local Institution
  • Limerick, Ireland
    • Local Institution
• Israel
  • Beer Sheva, Israel, 84101
    • Local Institution
  • Kfar-saba, Israel, 44281
    • Local Institution
  • Petah-tikva, Israel, 49100
    • Local Institution
  • Ramat-gan, Israel, 52621
    • Local Institution
  • Zerifin, Israel, 70300
    • Local Institution
• Italy
  • Livorno, Italy, 57100
    • Local Institution
  • Lucca, Italy, 55100
    • Local Institution
  • Meldola (FC), Italy, 47014
    • Local Institution
  • Siena, Italy, 53100
    • Local Institution
• Japan
  • Akashi, Hyogo, Japan, 673-8558
    • Local Institution
  • Fukoka, Japan, 811-1395
    • Local Institution
  • Fukuoka, Japan, 8128582
    • Local Institution
  • Osaka, Japan, 5898511
    • Local Institution
  • Oskaka, Japan, 5340021
    • Local Institution
  • Sapporo, Hokkaido, Japan, 0030804
    • Local Institution
  • Sendai, Miyagi, Japan, 980-0873
    • Local Institution
  • Tokyo, Japan, 135-8550
    • Local Institution
  • Aichi
    • Nagoya, Aichi, Japan, 4648681
      • Local Institution
    • Nagoya-shi, Aichi, Japan, 4600001
      • Local Institution
  • Chiba
    • Kashiwa, Chiba, Japan, 2778577
      • Local Institution
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 7910280
      • Local Institution
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608648
      • Local Institution
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 9208641
      • Local Institution
  • Kanagawa
    • Yokohama-Shi, Kanagawa, Japan, 2360051
      • Local Institution
    • Yokohama-shi, Kanagawa, Japan, 2408555
      • Local Institution
  • Miyagi
    • Natori, Miyagi, Japan, 981-1293
      • Local Institution
  • Okayama
    • Kurashiki-shi, Okayama, Japan, 7010192
      • Local Institution
    • Kurashiki-shi, Okayama, Japan, 710-8602
      • Local Institution
  • Osaka
    • Hirakata-shi, Osaka, Japan, 5731191
      • Local Institution
    • Takatsuki, Osaka, Japan, 5698686
      • Local Institution
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 4118777
      • Local Institution
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Local Institution
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 7550241
      • Local Institution
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Local Institution
  • Seoul, Korea, Republic of, 120-752
    • Local Institution
  • Seoul, Korea, Republic of, 135-710
    • Local Institution
  • Seoul, Korea, Republic of, 138-736
    • Local Institution
  • Seoul, Korea, Republic of, 136-705
    • Local Institution
  • Suwon, Korea, Republic of, 443-721
    • Local Institution
  • Suwon, Korea, Republic of, 442-723
    • Local Institution
  • Gyeonggji-do
    • Goyang-si, Gyeonggji-do, Korea, Republic of, 410-769
      • Local Institution
  • Jeonnam
    • Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of, 519-763
      • Local Institution
• Mexico
  • San Luis Potosi, S.l.p., Mexico, C.P. 78218
    • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Local Institution
  • Breda, Netherlands, 4818 CK
    • Local Institution
  • Eindhoven, Netherlands, 5623 EJ
    • Local Institution
• Peru
  • Cercado, Peru
    • Local Institution
  • Lima, Peru, 027
    • Local Institution
  • Lima, Peru, LIMA 41
    • Local Institution
• Poland
  • Elblag, Poland, 82-300
    • Local Institution
  • Karkow, Poland, 31-202
    • Local Institution
  • Lublin, Poland, 20-950
    • Local Institution
  • Otwock, Poland, 05-400
    • Local Institution
  • Poznan, Poland, 60-569
    • Local Institution
  • Torun, Poland, 87-100
    • Local Institution
  • Warszawa, Poland, 02-781
    • Local Institution
• Portugal
  • Coimbra, Portugal, 3041853
    • Local Institution
  • Lisboa, Portugal, 1099-023
    • Local Institution
• Romania
  • Bucuresti, Romania
    • Local Institution
  • Cluj, Romania, 400015
    • Local Institution
  • Judetul CLUJ
    • Cluj Napoca, Judetul CLUJ, Romania, 400058
      • Local Institution
  • Judetul DOLJ
    • Craiova, Judetul DOLJ, Romania, 200385
      • Local Institution
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Local Institution
  • Krasnodar, Russian Federation, 350040
    • Local Institution
  • Kursk, Russian Federation, 305035
    • Local Institution
  • Moscow, Russian Federation, 115478
    • Local Institution
  • Pyatigorsk, Russian Federation, 35702
    • Local Institution
  • Saint Petersburg, Russian Federation, 197758
    • Local Institution
  • Saint Petersburg, Russian Federation, 197022
    • Local Institution
  • St. Petersburg, Russian Federation, 198255
    • Local Institution
  • St. Petersburg, Russian Federation, 194291
    • Local Institution
• South Africa
  • Pretoria, South Africa, 0002
    • Local Institution
  • Eastern CAPE
    • Port Elizabeth, Eastern CAPE, South Africa, 6045
      • Local Institution
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7925
      • Local Institution
• Spain
  • Barcelona, Spain, 08035
    • Local Institution
  • Benidorm-alicante, Spain, 03501
    • Local Institution
  • Castellon, Spain, 12002
    • Local Institution
  • Lleida, Spain, 25198
    • Local Institution
  • Majadahonda, Spain, 28222
    • Local Institution
  • Malaga, Spain, 29010
    • Local Institution
  • Valencia, Spain, 46017
    • Local Institution
  • Galicia
    • A Coruna, Galicia, Spain, 15006
      • Local Institution
• Sweden
  • Linkoping, Sweden, 58185
    • Local Institution
  • Stockholm, Sweden, 17176
    • Local Institution
  • Uppsala, Sweden, 75185
    • Local Institution
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution
  • Winterthur, Switzerland, 8401
    • Local Institution
  • Zuerich, Switzerland, 8091
    • Local Institution
• Taiwan
  • Changhua City, Taiwan, R.O.C.
    • Local Institution
  • Taichung, Taiwan, 40705
    • Local Institution
  • Taipei, Taiwan, 100
    • Local Institution
  • Taoyuan County, Taiwan, 33305
    • Local Institution
• Thailand
  • Chiang Mai, Thailand, 50200
    • Local Institution
  • Songkhla, Thailand, 90110
    • Local Institution
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Local Institution
  • London, United Kingdom, N18 1QX
    • Local Institution
  • Preston, United Kingdom, PR2 9HT
    • Local Institution
  • Sutton, United Kingdom, SM2 5PT
    • Local Institution
  • Truro, United Kingdom, TR1 3LJ
    • Local Institution
  • Manchester
    • Withington, Manchester, United Kingdom, M20 4BX
      • Local Institution
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Auburn, California, United States, 95602
      • Sutter Medical Center
    • La Jolla, California, United States, 92093
      • UCSD Moores Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists S.
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists, LLC
    • Lake City, Florida, United States, 32024
      • Lake City Cancer Care
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Medical Oncology, LLC
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
    • Skokie, Illinois, United States, 60077
      • Presence Medical Group Hematology Oncology
    • Springfield, Illinois, United States, 62794-9678
      • SIU School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • St. Francis Medical Group Oncology And Hematology Specialist
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Ashland Bellefonte Cancer Center
    • Lexington, Kentucky, United States, 40536-0093
      • University of Kentucky
    • Mount Sterling, Kentucky, United States, 40353
      • Montgomery Cancer Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St Joseph Mercy Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Cancer Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Hematology & Oncology Consultants, P.C.
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Regional Cancer Care Associates, LLC/Cherry Hill Division
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Nassau
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Incorporated
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Cancer Specialists and Research Institute, LLC
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology Hematology Associates
    • Chattanooga, Tennessee, United States, 37421
      • Associated in Oncology and Hematology
    • Germantown, Tennessee, United States, 38138
      • The Jones Clinic, PC
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37232
      • Henry-Joyce Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • University Of Texas, M. D. Anderson Cancer Center
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research and Treatment Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Hospital
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Mary Babb Randolph Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

• Prior systemic therapy for lung cancer
• Symptomatic Central Nervous System (CNS) metastases
• History of autoimmune disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin; Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses	Drug: Cisplatin; Other Names: Platinol; Drug: Carboplatin; Other Names: Paraplatin; Drug: Etoposide; Other Names: Eposin; Etopophos; Neoposid; Biological: Ipilimumab; Other Names: BMS-734016; Yervoy
Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin; Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses	Drug: Cisplatin; Other Names: Platinol; Drug: Carboplatin; Other Names: Paraplatin; Drug: Etoposide; Other Names: Eposin; Etopophos; Neoposid; Biological: Placebo matching Ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.	Randomization until date of death, up to March 2015, approximately 38 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in All Randomized Participants	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.	From randomization until date of death, up to March 2015, approximately 38 months
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.	From randomization until disease progression, up to March 2015, approximately 38 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601. Erratum In: J Clin Oncol. 2019 Dec 1;37(34):3327.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2011
• Primary Completion (Actual): March 19, 2015
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

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; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Carboplatin; Etoposide; Ipilimumab
• Other Study ID Numbers: CA184-156; 2011-000850-48 (EudraCT Number)