An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from adult participants with metastatic Non-Small Cell Lung Cancer (NSCLC) for potential inclusion in the MSD Phase 3 clinical trial (Protocol No MK-1084-004) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit.

This is an interventional prospective clinical performance study to evaluate
the performance of the therascreen KRAS RGQ PCR Kit as a CDx in the MSD Phase 3
clinical trial assessing the safety and effectiveness of a new drug, MK-1084,
in participants with metastatic NSCLC.

To utilize the therascreen KRAS RGQ PCR Kit (KRAS Kit) as a screening test to
identify KRAS G12C mutations in newly diagnosed metastatic NSCLC participants
and thereby determine eligibility for enrolment into the Phase 3 clinical study
(MK-1084-004), evaluating the efficacy and safety of MK-1084 in combination
with pembrolizumab compared with placebo plus pembrolizumab, to demonstrate the
clinical performance of the therascreen KRAS RGQ PCR Kit.

This is an interventional prospective clinical performance study to evaluate 
the performance of the therascreen KRAS RGQ PCR Kit as a CDx in the MSD Phase 3 
clinical trial assessing the safety and effectiveness of a new drug, MK-1084, 
in participants with metastatic NSCLC. 

All participants will be asked to sign and date an Institutional Review 
Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form 
before their formalin-fixed tumor biopsy tissue samples are collected and sent 
to the Test Sites.

The KRAS test at the device test sites will be used to detect the KRAS G12C 
mutation in DNA extracted from FFPE tissue samples from participants with 
metastatic NSCLC, that are treatment-naïve in the metastatic setting, in order 
to determine KRAS G12C mutation eligibility for enrollment in the MSD Phase 3 
clinical study MK-1084-004.

Clinical data will be analyzed as part of the study to determine the device*s 
clinical utility in KRAS G12C mutated participants receiving MK-1084 in order 
to support future regulatory filings for the KRAS kit as a CDx for MK-1084.

To utilize the therascreen KRAS RGQ PCR Kit (KRAS Kit) as a screening test to
identify KRAS G12C mutations in newly diagnosed metastatic NSCLC participants
and thereby determine eligibility for enrolment into the Phase 3 clinical study
(MK-1084-004).

Potential Risks:

A Risk Management Plan was written in line with ISO 14971, and a risk 
assessment was conducted. The majority of risk has been mitigated through 
product design and manufacturing, including investigational device labelling. 
Given the nature of this device study and the mitigation of identified risks, 
the residual risk to participants whose sample specimen is tested is acceptable.

The identified potential harm to subjects as a result of KRAS G12C testing are 
as follows:
• Harm resulting from sample collection
• Harm due to a false negative KRAS G12C result
• Harm due to a false positive KRAS G12C result

Potential benefits:

The therascreen KRAS RGQ PCR Kit is intended for use in clinical trials to aid 
in the identification of NSCLC participants who harbour KRAS G12C mutation and 
may be eligible for treatment with MK-1084.