Description:
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.
Title
- Brief Title: Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CL3-95005-007
- SECONDARY ID:
2020-001976-14
- NCT ID:
NCT04737187
Conditions
- Refractory Metastatic Colorectal Cancer
Interventions
Drug | Synonyms | Arms |
---|
Trifluridine/Tipiracil | TAS102, S 95005, Lonsurf | trifluridine/tipiracil in combination with bevacizumab |
Bevacizumab | Avastin | trifluridine/tipiracil in combination with bevacizumab |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
trifluridine/tipiracil in combination with bevacizumab | Experimental | | - Trifluridine/Tipiracil
- Bevacizumab
|
trifluridine/tipiracil monotherapy | Active Comparator | | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | 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
Measure: | Progression-free survival (PFS) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | 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. |
Measure: | Overall response rate (ORR) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | 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 |
Measure: | Disease control rate (DCR) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | 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 |
Measure: | 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 |
Safety Issue: | |
Description: | Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs) |
Measure: | Quality of life: EORTC QLQ-C30 |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module. |
Measure: | Quality of life: EQ-5D-5L |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | Assess patients health and activities using the European Organization for Research and Treatment of Cancer Core Quality of Life (EQ-5D-5L) module. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Taiho Oncology, Inc. |
Trial Keywords
- trifluridine/tipiracil
- TAS102
- bevacizumab
- avastin
- RAS status (wild type, mutant)
Last Updated
August 3, 2021