Phase 1 Lung 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 diagnosed with one of the following advanced cancers: HER2-positive breast cancer (locally advanced, unable to be surgically removed, or spread to other parts of the body), hormone receptor-positive/HER2-negative breast cancer (advanced), colorectal cancer with a KRAS gene mutation (advanced), or non-small cell lung cancer with a KRAS gene mutation (advanced)
• People whose cancer can be measured on scans according to standard criteria (known as RECIST v1.1), except that people with hormone receptor-positive/HER2-negative breast cancer that has spread only to the bones may still be considered even if it cannot be measured in the standard way
• People who are relatively well and able to carry out everyday activities, rated 0 or 1 on a standard medical fitness scale (ECOG performance status)
• People with HER2-positive advanced breast cancer who have already received at least 2 previous treatments targeting HER2, or at least 1 previous HER2-targeted treatment if no other standard treatment options are available in their region
• People with hormone receptor-positive/HER2-negative advanced breast cancer, KRAS-mutant advanced colorectal cancer, or KRAS-mutant advanced non-small cell lung cancer (monotherapy group) whose cancer has grown or returned after at least one standard treatment, or where a treating doctor considers standard treatments are unlikely to be suitable or helpful
• People with hormone receptor-positive/HER2-negative advanced breast cancer joining the combination group with fulvestrant who have a confirmed PIK3CA gene mutation and have previously been treated with a CDK4/6 inhibitor (a specific type of cancer drug)
• People with hormone receptor-positive/HER2-negative advanced breast cancer joining the triple combination group (with fulvestrant and ribociclib) who have a confirmed PIK3CA gene mutation and have not yet received any systemic treatment for advanced breast cancer
• People with KRAS-mutant advanced colorectal cancer joining the chemotherapy combination group who may or may not have had one prior treatment containing a drug called irinotecan
• People with brain metastases (cancer that has spread to the brain) that are considered stable
• People joining certain treatment groups must have had their heart function assessed and found to be adequate (confirm with trial site)

Who may not be able to join:

• People with KRAS-mutant advanced colorectal cancer whose tumour has a specific KRAS G12R mutation, a BRAFV600E mutation, HER2 amplification, or a feature called dMMR/MSI-H
• People with KRAS-mutant advanced non-small cell lung cancer whose tumour has a specific KRAS G12R mutation, or has other gene changes that can be targeted by existing approved treatments (such as changes in EGFR, ALK, ROS1, BRAF, RET, MET, EGFR exon 20, NTRK, or HER2)
• People with brain metastases that have not been treated or are not considered stable
• Additional criteria are specified in the full trial protocol (confirm with trial site)

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