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History of Changes for Study: NCT04737187
Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT)
Latest version (submitted December 5, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 2, 2021 None (earliest Version on record)
2 February 8, 2021 Contacts/Locations and Study Status
3 August 2, 2021 Study Status and Contacts/Locations
4 January 4, 2022 Contacts/Locations and Study Status
5 January 27, 2022 Contacts/Locations and Study Status
6 April 4, 2022 Recruitment Status, Contacts/Locations and Study Status
7 February 7, 2023 Study Status
8 March 15, 2023 Contacts/Locations and Study Status
9 March 16, 2023 Study Status
10 July 12, 2023 Study Status
11 October 17, 2023
Quality Control Review has not concluded Returned: November 10, 2023
Recruitment Status, Study Status, Outcome Measures, Study Design, Document Section, Adverse Events, Baseline Characteristics, Participant Flow, References, Contacts/Locations and Conditions
12 December 5, 2023 Study Status, Outcome Measures, Adverse Events, Arms and Interventions, Document Section, More Information, Baseline Characteristics, Participant Flow, Contacts/Locations and Study Identification
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Study NCT04737187
Submitted Date:  July 12, 2023 (v10)

Open or close this module Study Identification
Unique Protocol ID: CL3-95005-007
Brief Title: Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT)
Official Title: An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)
Secondary IDs: 2020-001976-14 [EudraCT Number]
Open or close this module Study Status
Record Verification: July 2023
Overall Status: Active, not recruiting
Study Start: November 25, 2020
Primary Completion: July 19, 2022 [Actual]
Study Completion: September 2023 [Anticipated]
First Submitted: January 29, 2021
First Submitted that
Met QC Criteria:
February 2, 2021
First Posted: February 3, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
July 12, 2023
Last Update Posted: July 14, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Taiho Oncology, Inc.
Responsible Party: Sponsor
Collaborators: Institut de Recherches Internationales Servier
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.
Detailed Description: This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).
Open or close this module Conditions
Conditions: Refractory Metastatic Colorectal Cancer
Keywords: trifluridine/tipiracil
TAS102
bevacizumab
avastin
RAS status (wild type, mutant)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 490 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: trifluridine/tipiracil in combination with bevacizumab Drug: Trifluridine/Tipiracil
Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
Other Names:
  • TAS102
  • S 95005
  • Lonsurf
Drug: Bevacizumab
administered every 2 weeks (Day 1 and Day 15)
Other Names:
  • Avastin
Active Comparator: trifluridine/tipiracil monotherapy Drug: Trifluridine/Tipiracil
Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
Other Names:
  • TAS102
  • S 95005
  • Lonsurf
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Approximately 12 months ]

Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause
Secondary Outcome Measures:
1. Progression-free survival (PFS)
[ Time Frame: Approximately 12 months ]

Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 (Eisenhauer, 2009) by investigator's judgement or death from any cause, whichever comes first.
2. Overall response rate (ORR)
[ Time Frame: Approximately 12 months ]

Overall response rate defined as the proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria and using investigator's tumor assessment
3. Disease control rate (DCR)
[ Time Frame: Approximately 12 months ]

Disease control rate defined as the proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST version 1.1 criteria and using investigator's tumor assessment
4. Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs) for safety and tolerability assessment of study drug(s)
[ Time Frame: Approximately 12 months ]

Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
5. Quality of life: EORTC QLQ-C30
[ Time Frame: Approximately 12 months ]

Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module.
6. Quality of life: EQ-5D-5L
[ Time Frame: Approximately 12 months ]

Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EQ-5D-5L) module.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
  2. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy.
  3. Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.
  4. Has measurable or non-measurable disease as defined by RECIST version 1.1
  5. Is able to swallow oral tablets.
  6. Estimated life expectancy ≥12 weeks.
  7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

Exclusion Criteria:

  1. More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer.
  2. Pregnancy, lactating female or possibility of becoming pregnant during the study.
  3. Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization.
  4. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation).
  5. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
  6. Has severe or uncontrolled active acute or chronic infection.
  7. Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
  8. Known Hepatitis B or Hepatitis C Virus infection.
  9. Known carriers of HIV antibodies.
  10. Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia.
  11. Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization.
  12. Treatment with any of the following within the specified time frame prior to randomization:
    • major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
    • Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only.
    • Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization
  13. Other clinically significant medical conditions.
  14. Other malignancies.
Open or close this module Contacts/Locations
Study Officials: Josep Tabernero, Prof
Principal Investigator
Vall d'Hebron Institute of Oncology
Locations: United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
City of Hope
Duarte, California, United States, 91010
City of Hope - South Pasedena
South Pasadena, California, United States, 91030
City of Hope - Upland
Upland, California, United States, 91786
United States, Florida
Mayo Clinic - FL
Jacksonville, Florida, United States, 32224
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Comprehensive Hematology Oncology
Saint Petersburg, Florida, United States, 33709
United States, Illinois
DuPage Medical Group - Joliet Oncology-Hematology Associates
Joliet, Illinois, United States, 60435
United States, Indiana
Investigative Clinical Research of Indiana LLC
Noblesville, Indiana, United States, 46062
United States, Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New York
Mayo Clinic - Rochester
Rochester, New York, United States, 55905
United States, Texas
Renovatio Clinical - El Paso
El Paso, Texas, United States, 79915
Austria
"Medizinische Universität Graz "
Graz, Austria, 8036
"Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"
Innsbruck, Austria, 6020
"Ordensklinikum Linz Barmherzige Schwestern Interne I"
Linz, Austria, 4010
"Landeskrankenhaus Feldkirch Interne E"
Rankweil, Austria, 6830
"Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"
Salzburg, Austria, 5020
"Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"
Wien, Austria, 1090
"Landesklinikum Wiener Neustadt "
Wiener Neustadt, Austria, 2700
Belgium
"OLV Ziekenhuis Oncology"
Aalst, Belgium, 9300
"Universitair Ziekenhuis Antwerpen Oncologie"
Edegem, Belgium, 2650
"UZ Leuven Campus Gasthuisberg Digestieve Oncologie"
Leuven, Belgium, 3000
"CHC Montlégia Oncologie"
Liege, Belgium, 4000
"AZ NIKOLAAS Oncology"
Sint Niklaas, Belgium, 9100
Brazil
"Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"
Barretos, Brazil, 14784-400
"Hospital de Base Centro Integrado de Pesquisa"
Sao Jose Do Rio Preto, Brazil, 15090-000
"ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"
Sao Paulo, Brazil, 01246-000
Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente
Sao Paulo, Brazil, 01509-900
Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein
Sao Paulo, Brazil, 05652- 900
Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado
São Paulo, Brazil, 03102-002
Denmark
"Aalborg Universitetshospital, Syd Onkologisk Afdeling"
Aalborg, Denmark, 9000
Rigshospitalet Dpt of Oncology
Copenhagen, Denmark, 2100
"Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"
Herning, Denmark, 7400
"Odense Universitetshospital Department of Oncology"
Odense, Denmark, 5000
France
"CHU Jean Minjoz Service d'oncologie médicale"
Besancon, France, 25030
"CHU Morvan Institut de Cancérologie et d'Hématologie"
Brest, France, 29200
"Centre de lutte contre le cancer Francois Baclesse UCP Digestif"
Caen, France, 14076
Hôpital Saint-Antoine Service d'Oncologie Médicale
Paris, France, 75012
"Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"
Paris, France, 75015
CHU de Poitiers Pole Régional de Cancérologie
Poitiers, France, 86021
Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, Germany, 10707
Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie
Berlin, Germany, 13353
Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
Luebeck, Germany, 23562
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
Muenchen, Germany, 81377
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly
Budapest, Hungary, 1062
Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly
Budapest, Hungary, 1115
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
Győr, Hungary, 9024
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
Kecskemét, Hungary, 6000
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
Szeged, Hungary, 6720
JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
Szolnok, Hungary, 5004
Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
Szombathely, Hungary, 9700
Italy
A.O.U. Seconda Universita degli Studi di Napoli U.O.C di Oncologia Medica e di Ematologia Dipartimento Medico di Internistica clinca e sperimentale " F Magrassi - A. Lanzara" Via Sergio Pansisni ,
Napoli, Italy, 80131
Istituto Nazionale Tumori, I.R.C.C.S "Fondazione G Pascale" Struttura Complessa di Oncologia Medica Addominale
Napoli, Italy, 80131
Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64
Padova, Italy, 35128
A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
Pisa, Italy, 56126
Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana
Potenza, Italy, 85100
Arcispedale Santa Maria Nuova Unità di Oncologia
Reggio Emilia, Italy, 42123
Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,
Rozzano (MI), Italy, 20089
IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1
San Giovanni Rotondo, Italy, 71013
Italy, Italiy
Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato
Cagliari, Italiy, Italy, 9100
Poland
Przychodnia Lekarska "KOMED"
Konin, Poland, 62-500
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
Krakow, Poland, 31-531
Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
Opole, Poland, 45-061
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, Poland, 76-200
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii
Warszawa, Poland, 02-034
Wojskowy Instytut Medyczny Klinika Onkologii
Warszawa, Poland, 04-141
Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii
Warzszawa, Poland, 02-507
Puerto Rico
Pan American Center for Oncology Trials, LLC
Río Piedras, Puerto Rico, 00935
Russian Federation
Arkhangelsk Clinical Oncology Dispensary chemotherapy department
Arkhangelsk, Russian Federation, 163045
Clinical Oncology Dispensary No.1 Chemotherapy Department
Krasnodar, Russian Federation, 350040
Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation, 115478
University Headache Clinic Outpatient oncology clinic
Moscow, Russian Federation, 121467
Moscow City Oncology Hospital # 62 chemotherapy department
Moscow Region, Russian Federation, 143423
Omsk Clinical Oncologic Dispensary Chemotherapy
Omsk, Russian Federation, 644046
National Medical Research Center of Oncology N.N. Petrova
Saint-petersburg, Russian Federation, 197758
Multidisciplinary clinic "Reaviz
Samara, Russian Federation, 443011
Oncology dispensary No.2 Oncology department
Sochi, Russian Federation, 354057
Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
St Petersburg, Russian Federation, 115478
Saint Petersburg City Oncology Clilnic
St Petersburg, Russian Federation, 198255
SBIH of YR "Clinical oncology hospital chemotherapy department"
Yaroslavl, Russian Federation, 150054
Spain
"H. Valle de Hebrón Servicio de Oncología - (VHIR)"
Barcelona, Spain, 08035
"Hospital de la Santa Creu I Sant Pau Oncología Medica"
Barcelona, Spain, 08041
"Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"
Cordoba, Spain, 14004
"INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"
Hospitalet de Llobregat, Spain, 08908
"Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"
Madrid, Spain, 28034
"HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"
Madrid, Spain, 28041
"Hospital Universitario Marqués de Valdecilla oncología medica"
Santander, Spain, 39008
H.VIRGEN DEL ROCIO Servicio de Oncología Médica
Sevilla, Spain, 41013
H. GENERAL DE VALENCIA Servicio de Oncología Médica
Valencia, Spain, 46014
Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical
Zaragoza, Spain, 50009
Ukraine
Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
Cherkassy, Ukraine, 18009
"MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"
Dnipro, Ukraine, 49102
LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department
Kropyvnytskyi, Ukraine, 25011
National Institute of Cancer Abdominal Oncology Department
Kyiv, Ukraine, 03022
Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology
Kyiv, Ukraine, 08112
"Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"
Kyiv, Ukraine, 08720
Podillia Regional Oncology Centre Chemotherapy Department
Vinnitsya, Ukraine, 21029
Ukraine, Ukrain
Kyiv City Clinical Oncological Centre
Kiev, Ukrain, Ukraine, 03115
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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