Non-Small Cell Lung Cancer Lung Cancer
Conditions
Interventions
The investigational device, therascreen® KRAS RGQ PCR system (extraction kit, analytical kit, instrument, and software), will be used per relevant instructions for use to test Formalin-fixed paraffin-
including incisional or excisional biopsies) tumor tissue samples from NSCLC participants to establish KRAS 
G12C mutation status. 
This will be determined using the investigational device at the Test Sites in the US (Hematogenix) and Mainland China (IQVIA Laboratories Beijing).
Sponsors
QIAGEN Manchester Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the MSD clinical trial can be found in the MK-1084-015 clinical trial protocol. In addition, the following sample inclusion criteria will apply specifically for the clinical performance study: Tissue must be a FFPE tumor specimen submitted for patient screening for MK-1084-015 clinical trial or retrospective testing of KRAS G12C status (if locally tested); Tissue samples must be shipped ambient;Newly obtained fine needle aspirate (FNA), core needle biopsy (CNB) or resection (including incisional or excisional biopsies) of a tumor lesion, which was not previously irradiated, or archived tumor tissue (=5 years, if a new a biopsy is unavailable); FFPE specimen must contain tumor tissue for testing as described in the therascreen® KRAS RGQ PCR kit instructions for use;Tumor tissue must be fixed in 10% neutral buffered formalin and embedded in paraffin (FFPE); Tumor samples must be from a FFPE block which may be submitted as either a block or fresh serially cut slides* If fresh serially cut slides are submitted: A minimum of 3 (but preferably at least 5 to account for a repeat extraction) unstained 4-5µm sections; Slides must be sectioned within 56 weeks for FNA samples, and within 70 weeks for CNB and resection samples of the testing date; Consent should be obtained prior to or at the time of collection and not withdrawn at the time of the CDx testing** *Only FFPE slides are accepted in China as per HGRAC policy and the number of slides is defined per HGRAC. **MSD remains responsible for ensuring the subject has not withdrawn consent prior to sample analysis.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the MSD clinical trial can be found in the MK-1084-015 clinical trial protocol. In addition, a specimen will be excluded from the performance study if any of the following criteria are true: Specimen does not show tumor tissue on the Hematoxylin and Eosin (H&E) slide; Specimen submitted on uncharged slides;Specimen submitted on baked slides; Specimen is a brushing, cell pellets from pleural effusion, bone biopsy or lavage sample; Specimen consists of tissue that has been decalcified;Specimen shows visible damage or is unclearly labelled;Specimen known to have been frozen at any point
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary 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 primary efficacy endpoint from the MK-1084-015 clinical trial. Efficacy of the CDx and MK-1084 will be determined via assessment of PFS per RECIST 1.1 by BICR by the investigator based onthe MSD MK-1084-015 Clinical Protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the endpoint above, the following exploratory endpoints will be evaluated and reported in the Clinical Performance Study Report: Number of samples received by the test sites not suitable for KRAS G12C mutation testing;Number of samples reported as Indeterminate (i.e. where a valid result was not obtained following all actions on the IFU);Number of patients for whom the shipment of more than 1 sample (under new accession) to the central labs was required to generate a valid result;For patients enrolled based on a local test result, positive percent agreement (PPA) between the CDx (central testing under the scope of this device study) and the local result; Number of AEs and SAEs linked to the device and Device deficiencies. | — |
Countries
Argentina, Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactS Johnson
QIAGEN Manchester Limited
Outcome results
None listed