At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- therascreen® KRAS RGQ PCR Kit (device)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- therascreen® KRAS RGQ PCR Kit — device: The investigational device, therascreen® KRAS RGQ PCR Kit, will be used to determine the KRAS G12C mutation status of patients during the screening period of Amgen's clinical trial (20210081)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a test called the Therascreen KRAS RGQ PCR Kit, which checks tumour tissue for a change in a gene called KRAS (known as the G12C mutation). The study includes people taking part in the eligibility screen for another study, Protocol 20210081. It is for people with metastatic colorectal cancer (mCRC), which means bowel cancer that has spread to other parts of the body.
Who can take part
- People who agree to take part in the eligibility screen for Protocol 20210081. Their tumour tissue will be tested for the KRAS G12C gene change.
Who may not be able to
- Not stated — ask the trial team. The study data says there are no separate inclusion and exclusion criteria for this performance study.
What taking part involves
- • Having your tumour tissue tested for the KRAS G12C mutation using the Therascreen KRAS RGQ PCR Kit
Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2023-12-22
- Last checked
- 2025-08
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic colorectal cancer (mcrc)
- • NA - 600 participants
- • To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic colorectal cancer (mcrc)
Where?
- • Manchester - QIAGEN Gaithersburg, Inc
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.
More detail
The proposed device clinical performance study and the medicinal clinical trial will be conducted simultaneously as a combined trial according to MDCG 2022-10. The clinical trial 20210081 is a Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects with Metastatic Colorectal Cancer with KRAS p.G12C Mutation (CodeBreaK 301). It is estimated that approximately 450 patients from 31 countries will be enroled based on the presence of tumor KRAS G12C mutation, detected using therascreen KRAS RGQ PCR Kit, along with other clinical trial inclusion criteria, into the Phase III clinical trial. Results from the Phase 3 Amgen Study 20210081 will be used to evaluate the clinical performance of therascreen® KRAS RGQ PCR Kit as a CDx device for identification of patients with mCRC who may benefit from treatment with sotorasib in treatment-naïve patients with metastatic colorectal cancer.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue...
Who cannot take part
- ✗There is no separate inclusion and exclusion criteria for the performance study.
See the full criteria
Where Is This Study? (1 UK site)
QIAGEN Gaithersburg, Inc
Manchester M130BH, United Kingdom
How to Get in Touch
Sarah Johnson, Dr.
Sponsor contactCONTACT
Parul Choudhary
Sponsor contactCONTACT