Old study title: 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. New study title: An interventional, prospective and retrospective IVD device study for the testing of DNA extracted from tumor tissue

Old study title: 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. New study title: An interventional, prospective and retrospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from adult participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in thecontext of MSD Phase 3 clinical trial (Protocol NoMK-1084-004) to demonstrate clinical performance of the therascreen® KRAS RGQPCR Kit. - An interventional prospective IVD device study for the testing of DNA extracted from tumor tissue b

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57094

Enrollment

Registered

2024-11-08

Start date

2025-02-24

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer Lung cancer

Interventions

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 enro

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants who consented to participate in MK-1084-004 will provide an  archived tumor tissue (FFPE) sample. If archived tumor tissue is not available,  then a fresh tumor tissue sample must be obtained. Clinical trial samples will only be tested if participants have signed the ICF  permitting the use of their samples in the clinical study. Participants must  provide a valid tissue sample.

Exclusion criteria

Exclusion criteria: If the biopsy sample doesn*t show a tumor on the Hematoxylin and Eosin (H&E) slide or doesn*t meet device sample requirements, the sample will be considered not evaluable. Participants whose tumor tissue biopsy samples are not evaluable will be excluded from the study. Additionally, participants with samples identified for the study which have insufficient testing material (not sufficient DNA quantity) will also be excluded.

Design outcomes

Primary

Measure	Time frame
Performance study endpoint is to demonstrate that the therascreen KRAS RGQ PCR Kit is safe and effective to identify participants for MK-1084 treatment, as supported by the efficacy endpoints from the MK-1084-004 clinical trial.	—

Countries

Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, France, Georgia, Germany, Greece, India, Italy, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, South Korea, Spain, Ukraine, United Kingdom, United States

Contacts

Public ContactS. Johnson

QIAGEN Manchester Limited

competentauthoritysubmissions@qiagen.com+447825866041

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026