Phase 3 Colorectal Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with colorectal cancer (cancer of the colon or rectum) that has spread to other parts of the body or cannot be surgically removed, confirmed by a laboratory test on a tissue or cell sample.
• People who are able to provide a stored tumour tissue sample (preserved in a special wax block or as prepared slides) from before any treatment started, for testing at a central lab — or, if no stored sample exists, people who can have a new tissue sample taken from an accessible tumour within 35 days before the study begins.
• People whose tumour tests positive for a protein called HER2, based on a tissue test done at a central laboratory.
• People whose tumour has a normal (unchanged) version of a gene called RAS, confirmed by local or central testing — and if central testing is used, the tissue sample must have been collected within the past year.
• People who have at least one area of cancer that can be measured on a scan, either in a spot that has not previously received radiation, or in a previously radiated spot that has since shown signs of growth.
• People who are generally well enough to carry out light activity and care for themselves (a standard health performance score of 0 or 1 on a common medical scale).
• People who have no brain metastases, or who have brain metastases that have already been treated and are not currently causing symptoms.

Who may not be able to join:

• People who have already received systemic cancer treatment (such as chemotherapy given throughout the body) for advanced or metastatic colorectal cancer — although people who have had no more than 2 doses of a specific chemotherapy regimen called mFOLFOX6 for advanced disease before joining may still be considered.
• People who received chemotherapy for colorectal cancer as a preventative treatment after surgery are not excluded, as long as that treatment was completed more than 6 months before enrolling.
• People who have had radiation therapy within the 14 days before enrolling (or within 7 days if a targeted type of radiation called stereotactic radiosurgery was used).
• People who have previously been treated with any anti-HER2 therapy.
• People who currently have nerve damage rated as severe (Grade 3 or higher on a standard medical scale).
• People who have an active or untreated hole or tear in their digestive tract (gastrointestinal perforation) at the time of screening.

Important: Always verify eligibility with the trial site directly before applying.