Other Trials You Should Know About

Learn about first-line trials with Dr. George

This blog post is from a series about first-line trials from PALTOWN Scientific Director Dr. Manju George.

How is everyone doing? Thanks to all who worked hard in helping make the transition to this new space seamless and smooth!

It’s Tuesday, so I’m back with another post on #1LClinicalTrials.

If you missed the previous 2 posts, you can find them here:

In today’s post, let us look at other 1L clinical trials available for stage IV and earlier stage CRC patients.

If you are unclear about what 1L trials are please see my post on that topic. Basically, it’s a clinical trial you can get on immediately after diagnosis, before you have started any treatment.

Julie Clauer had made these beautiful and easy to follow slides, so I’m adding these here. This shows you that there are trials

  • for stage 2, 3 or 4,
  • for colon & for rectal cancer,
  • for those with specific biomarkers like HER2/ERBB2 amplification and for those with a KRAS G 12C mutation or for those patients who have MSI-H BRAF mutated CRC.
  • And we also have a 1L trial for those with BRAF/KRAS wild type left-sided stage IV CRC patients!

So there’s 1L trials for all many subsets of CRC!🔥🔥

An issue with 1L trials is that patients need to know of them to ask for them. Or if their care team tells them about 1L trials, and they need to learn more, we need a way to bring the information to patients and caregivers to help them with these decisions.

Some of the trials in the slides below are no longer enrolling, but the point is for patients to know Il trials exist, so they can ask about them.

I covered the ERASur trial in an earlier post. 

The MOUNTAINEER-03 trial is for ERBB2/HER2 amplification. This is one of those biomarkers that’s important in colorectal cancer. So please make sure, if you have been diagnosed with stage IV CRC to ask for ERBB2/HER2 status. You can laern more about trials and treatments available for ERBB2/HER2 in this wonderful DocTalk from Dr. John Strickler. 

The SEMARK trial shows as active not recruiting. This one compared Pembrolizumab+ Encorafenib+ Cetuximab versus Pembrolizumab alone in patients with deficient mismatch repair metastatic BRAF mutated CRC.

For stage 2 & 3 patients, we have the CIRCULATE North America Trial for colon cancer patients (open in both the US & Canada) and the JANUS trial for rectal cancer patients. We have DocTalks on both these trials in the Lecture Hall at CTU.

The NEO-RT is an enrolling clinical trial for stage 1 rectal cancer patients open in Canada & the US. It is a phase 3 randomized trial of neoadjuvant chemo, excision and observation versus chemoRT. We have a video short on this trial 

For those who have MSI-H CRC, there’s the choice of AZUR-1 for rectal cancer patients & AZUR-2 for colon cancer patients.

Not included in the slides below is the OriGAMI-2 trial, which is for KRAS & BRAF wild type (or unmutated) stage 4 metastatic left-sided CRC patients.

And we have a video about this trial as well! 

The CodeBreak 301 is a 1L trial that combined the KRAS G12C inhibitor Sotorasib with EGFR inhibitor, Panitumumab & FOLFIRI and is available for those with KRAS G12C mutated CRC Ascopubsascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS326

Many of the industry-sponsored trials like Azur, SEAMARK etc are usually open in Canada as well.

I hope this post is helpful..