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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:  February 2, 2021 (v1)
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: February 2021
Overall Status: Recruiting
Study Start: November 25, 2020
Primary Completion: December 2022 [Anticipated]
Study Completion: December 2022 [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:		 February 2, 2021
Last Update Posted: February 3, 2021 [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
Central Contact Person: Karim Benhadji, MD
Telephone: 609-250-7336
Email: clinicaltrialinfo@taihooncology.com
Study Officials: Josep Tabernero, Prof
Principal Investigator
Vall d'Hebron Institute of Oncology
Locations: Spain
Hospital de la Santa Creu I Sant Pau
[Recruiting]
Barcelona, Spain, 08041
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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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services