Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients (SUNLIGHT)

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)

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.

Study Overview

• Status: Completed
• Conditions: Refractory Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Trifluridine/Tipiracil; Drug: Bevacizumab

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).

• Study Type: Interventional
• Enrollment (Actual): 492
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • "Medizinische Universität Graz "
  • Innsbruck, Austria, 6020
    • "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"
  • Linz, Austria, 4010
    • "Ordensklinikum Linz Barmherzige Schwestern Interne I"
  • Rankweil, Austria, 6830
    • "Landeskrankenhaus Feldkirch Interne E"
  • Salzburg, Austria, 5020
    • "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"
  • Wien, Austria, 1090
    • "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"
  • Wiener Neustadt, Austria, 2700
    • "Landesklinikum Wiener Neustadt "
• Belgium
  • Aalst, Belgium, 9300
    • "OLV Ziekenhuis Oncology"
  • Edegem, Belgium, 2650
    • "Universitair Ziekenhuis Antwerpen Oncologie"
  • Leuven, Belgium, 3000
    • "UZ Leuven Campus Gasthuisberg Digestieve Oncologie"
  • Liege, Belgium, 4000
    • "CHC Montlégia Oncologie"
  • Sint Niklaas, Belgium, 9100
    • "AZ NIKOLAAS Oncology"
• Brazil
  • Barretos, Brazil, 14784-400
    • "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"
  • Sao Jose Do Rio Preto, Brazil, 15090-000
    • "Hospital de Base Centro Integrado de Pesquisa"
  • Sao Paulo, Brazil, 01246-000
    • "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"
  • Sao Paulo, Brazil, 01509-900
    • Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente
  • Sao Paulo, Brazil, 05652- 900
    • Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein
  • São Paulo, Brazil, 03102-002
    • Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado
• Denmark
  • Aalborg, Denmark, 9000
    • "Aalborg Universitetshospital, Syd Onkologisk Afdeling"
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Dpt of Oncology
  • Herning, Denmark, 7400
    • "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"
  • Odense, Denmark, 5000
    • "Odense Universitetshospital Department of Oncology"
• France
  • Besancon, France, 25030
    • "CHU Jean Minjoz Service d'oncologie médicale"
  • Brest, France, 29200
    • "CHU Morvan Institut de Cancérologie et d'Hématologie"
  • Caen, France, 14076
    • "Centre de lutte contre le cancer Francois Baclesse UCP Digestif"
  • Paris, France, 75012
    • Hôpital Saint-Antoine Service d'Oncologie Médicale
  • Paris, France, 75015
    • "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"
  • Poitiers, France, 86021
    • CHU de Poitiers Pole Régional de Cancérologie
• Germany
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfuerstendamm
  • Berlin, Germany, 13353
    • Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie
  • Luebeck, Germany, 23562
    • Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei
  • Muenchen, Germany, 81377
    • Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
  • Budapest, Hungary, 1115
    • Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet
  • Győr, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly
  • Kecskemét, Hungary, 6000
    • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika
  • Szolnok, Hungary, 5004
    • JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum
  • Szombathely, Hungary, 9700
    • Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly
• Italy
  • Napoli, Italy, 80131
    • 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
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64
  • Pisa, Italy, 56126
    • A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2
  • Potenza, Italy, 85100
    • Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova Unità di Oncologia
  • Rozzano (MI), Italy, 20089
    • Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,
  • San Giovanni Rotondo, Italy, 71013
    • IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1
  • Italiy
    • Cagliari, Italiy, Italy, 9100
      • Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato
• Poland
  • Konin, Poland, 62-500
    • Przychodnia Lekarska "Komed"
  • Krakow, Poland, 31-531
    • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
  • Opole, Poland, 45-061
    • Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej
  • Słupsk, Poland, 76-200
    • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
  • Warszawa, Poland, 02-034
    • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny Klinika Onkologii
  • Warzszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii
• Puerto Rico
  • Río Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Clinical Oncology Dispensary chemotherapy department
  • Krasnodar, Russian Federation, 350040
    • Clinical Oncology Dispensary No.1 Chemotherapy Department
  • Moscow, Russian Federation, 115478
    • Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy
  • Moscow, Russian Federation, 121467
    • University Headache Clinic Outpatient oncology clinic
  • Moscow Region, Russian Federation, 143423
    • Moscow City Oncology Hospital # 62 chemotherapy department
  • Omsk, Russian Federation, 644046
    • Omsk Clinical Oncologic Dispensary Chemotherapy
  • Saint-petersburg, Russian Federation, 197758
    • National Medical Research Center of Oncology N.N. Petrova
  • Samara, Russian Federation, 443011
    • Multidisciplinary clinic "Reaviz
  • Sochi, Russian Federation, 354057
    • Oncology dispensary No.2 Oncology department
  • St Petersburg, Russian Federation, 115478
    • Scientific Centre for Specialized Medical Care (oncological) Chemotherapy
  • St Petersburg, Russian Federation, 198255
    • Saint Petersburg City Oncology Clilnic
  • Yaroslavl, Russian Federation, 150054
    • SBIH of YR "Clinical oncology hospital chemotherapy department"
• Spain
  • Barcelona, Spain, 08035
    • "H. Valle de Hebrón Servicio de Oncología - (VHIR)"
  • Barcelona, Spain, 08041
    • "Hospital de la Santa Creu I Sant Pau Oncología Medica"
  • Cordoba, Spain, 14004
    • "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"
  • Hospitalet de Llobregat, Spain, 08908
    • "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"
  • Madrid, Spain, 28034
    • "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"
  • Madrid, Spain, 28041
    • "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"
  • Santander, Spain, 39008
    • "Hospital Universitario Marqués de Valdecilla oncología medica"
  • Sevilla, Spain, 41013
    • H.VIRGEN DEL ROCIO Servicio de Oncología Médica
  • Valencia, Spain, 46014
    • H. GENERAL DE VALENCIA Servicio de Oncología Médica
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical
• Ukraine
  • Cherkassy, Ukraine, 18009
    • Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre
  • Dnipro, Ukraine, 49102
    • "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"
  • Kropyvnytskyi, Ukraine, 25011
    • LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department
  • Kyiv, Ukraine, 03022
    • National Institute of Cancer Abdominal Oncology Department
  • Kyiv, Ukraine, 08720
    • "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"
  • Kyiv, Ukraine, 08112
    • Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology
  • Vinnitsya, Ukraine, 21029
    • Podillia Regional Oncology Centre Chemotherapy Department
  • Ukrain
    • Kiev, Ukrain, Ukraine, 03115
      • Kyiv City Clinical Oncological Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • South Pasadena, California, United States, 91030
      • City of Hope - South Pasedena
    • Upland, California, United States, 91786
      • City of Hope - Upland
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - FL
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Saint Petersburg, Florida, United States, 33709
      • Comprehensive Hematology Oncology
  • Illinois
    • Joliet, Illinois, United States, 60435
      • DuPage Medical Group - Joliet Oncology-Hematology Associates
  • Indiana
    • Noblesville, Indiana, United States, 46062
      • Investigative Clinical Research of Indiana LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • New York
    • Rochester, New York, United States, 55905
      • Mayo Clinic - Rochester
  • Texas
    • El Paso, Texas, United States, 79915
      • Renovatio Clinical - El Paso

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trifluridine/Tipiracil + Bevacizumab; Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 an Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram [mg/kg], intravenous [IV] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.	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: Lonsurf; TAS102; S 95005; Drug: Bevacizumab; administered every 2 weeks (Day 1 and Day 15); Other Names: Avastin
Active Comparator: Trifluridine/Tipiracil; Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.	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: Lonsurf; TAS102; S 95005

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.	From date of randomization to the death due to any cause or cut-ff date, whichever comes first (maximum duration: up to 20 months)
Survival Probability at 6 Months	Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported.	From date of randomization until 6 months post treatment
Survival Probability at 12 Months	Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported.	From date of randomization until 12 months post treatment
Survival Probability at 18 Months	Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported.	From date of randomization until 18 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.	From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)
Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months	PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported.	From randomization until 3, 6, 9, and 12 months post treatment
Overall Response Rate (ORR)	Objective response was defined as percentage of participants who achieved complete response (CR) or partial response (PR) according to the RECIST version 1.1 and using investigator's tumour assessment. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.	From the date of randomization to the date of documentation of progression or death due to any cause or data cut-off, whichever occurred first (i.e., up to 20 months)
Percentage of Participants With Disease Control	Disease control is defined as percentage of participants who achieved CR or PR, or stable disease (SD) as per RECIST 1.1 and using investigator's tumour assessment from the date of randomization to until disease progression or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.	From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)	An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (time from the first dose of study treatment up to 30 days after the last dose of study treatment). TEAEs included both SAEs and non-SAEs.	From Baseline up to 30 days after the last dose of study treatments (i.e., up to 19.5 months)

Collaborators and Investigators

• Sponsor: Taiho Oncology, Inc.
• Collaborators: Institut de Recherches Internationales Servier
• Investigators: Principal Investigator: Josep Tabernero, Prof, Vall d'Hebron Institute of Oncology

Publications and helpful links

General Publications

• Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Papai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: bevacizumab; avastin; TAS102; RAS status (wild type, mutant); trifluridine/tipiracil/lonsurf
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Trifluridine
• Other Study ID Numbers: CL3-95005-007; 2020-001976-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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