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Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT)

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ClinicalTrials.gov Identifier: NCT04737187
Recruitment Status : Active, not recruiting
First Posted : February 3, 2021
Last Update Posted : July 14, 2023
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Refractory Metastatic Colorectal Cancer Drug: Trifluridine/Tipiracil Drug: Bevacizumab Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : July 19, 2022
Estimated Study Completion Date : September 2023

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Arms and Interventions
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Arm Intervention/treatment
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 Name: 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


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737187


Locations
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Sponsors and Collaborators
Taiho Oncology, Inc.
Institut de Recherches Internationales Servier
Investigators
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Principal Investigator: Josep Tabernero, Prof Vall d'Hebron Institute of Oncology
More Information
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04737187    
Other Study ID Numbers: CL3-95005-007
2020-001976-14 ( EudraCT Number )
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
trifluridine/tipiracil
TAS102
bevacizumab
avastin
RAS status (wild type, mutant)
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Trifluridine
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents