CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 400 target
Drug / intervention
tucatinib +7 moredrug
Likely dose
tucatinib 300mgfrom record
Key inclusion· 6
  • ✓Histologically or cytologically confirmed adenocarcinoma of colon or rectum, locally advanced unresectable or metastatic
  • ✓HER2-positive disease by tissue-based assay at central laboratory
  • ✓RAS wild-type disease by local or central testing
  • ✓Radiographically measurable disease per RECIST v1.1 with at least one unmeasured lesion or evidence of progression after prior radiation
Key exclusion· 6
  • ✕Prior systemic anticancer therapy for CRC in locally advanced unresectable or metastatic setting, except maximum 2 doses of mFOLFOX6 allowed in this setting
  • ✕Adjuvant chemotherapy if not completed >6 months prior to enrollment
  • ✕Radiation therapy within 14 days prior to enrollment (or within 7 days for stereotactic radiosurgery)
  • ✕Previous treatment with anti-HER2 therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05253651
NCT05253651Phase 3RecruitingOn Track
Long Recruiting
CompareCT.gov

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Seagen, a wholly owned subsidiary of Pfizer·interventional·Posted Feb 24, 2022·Updated Jun 4, 2026

In Brief

A Phase 3 clinical trial evaluating tucatinib, trastuzumab, and 6 other interventions for Colorectal Neoplasms. Currently recruiting, targeting 400 participants across 381 sites in 25 countries.

Detailed Summary

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3Recruiting
202220232024202520262027202820292030
First PostedFeb 24, 2022
Enrollment StartOct 24, 2022
Primary CompletionDec 31, 2027
Study CompletionJul 3, 2030
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 4.4 years agoPrimary completion in 1.5 years

Arms & Interventions

Tucatinib Armexperimental

Tucatinib + trastuzumab + mFOLFOX6

Drug: tucatinibDrug: trastuzumabDrug: oxaliplatinDrug: leucovorinDrug: levoleucovorinDrug: fluorouracil
Standard of Care Armactive_comparator

Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab

Drug: bevacizumabDrug: cetuximabDrug: oxaliplatinDrug: leucovorinDrug: levoleucovorinDrug: fluorouracil

Interventions

tucatinibdrug

300mg given by mouth (orally) twice daily

trastuzumabdrug

8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.

bevacizumabdrug

5mg/kg given by IV every 2 weeks

cetuximabdrug

400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly

oxaliplatindrug

85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

leucovorindrug

400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

levoleucovorindrug

200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.

fluorouracildrug

400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.