Pairing New Cancer Drugs to Improve Treatment for HER2 Positive Colorectal Cancer

Recruiting · Phase 3 · Colorectal Neoplasms · 19 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This study is exploring if tucatinib, combined with other cancer drugs, works better than standard treatment for people with HER2 positive metastatic colorectal cancer. The goal is to see how effective this new combination is and to learn about any side effects that might occur. Participants will be assigned randomly to either the group receiving tucatinib or the group getting standard treatment.

The trial's ID number is NCT05253651. It is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include about 400 participants.

Who can join

This trial is open to adults aged 18 and older, including both men and women. To join, participants must have a specific type of colorectal cancer that has spread or cannot be removed by surgery. The trial team will check to make sure everyone meets the eligibility criteria before they can join.

Condition

Colorectal Neoplasms

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be split into two groups by chance. One group will receive tucatinib, trastuzumab, and mFOLFOX6. The other group will receive standard care, which could be mFOLFOX6 alone, or mFOLFOX6 with either bevacizumab or cetuximab. Everyone will receive their treatment as directed by the trial team.