Lung Cancer, KRAS mutant Cancer
Conditions
Interventions
Sponsors
QIAGEN Manchester Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants with advanced (Stage IIIB, Stage IIIC not eligible for curative resection or chemoradiation) or metastatic nonsquamous NSCLC of any sex/gender who are at least 18 years of age, that are treatment-naïve in the advanced/metastatic setting, who consented to participate in MK-1084-007 will provide an FFPE tumor sample (archival or newly obtained). The clinical site principal investigator and MSD will be accountable that the participants from whom the samples are collected from are eligible according to inclusion criteria listed the corresponding section of the MK-1084-007 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-1084-007 clinical trial or retrospective testing of KRAS G12C status (if locally tested);Tissue samples must be shipped ambient;Newly obtained core needle biopsy 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 FPPE block which may be submitted as either a block of 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 mounted on positively charged glass slides are expected;Slides must be sectioned within 70 weeks of the testing date;Consent should be obtained prior to or at the time of collection and not withdrawn at the time of the CDx testing** *Only FPPE slides are accepted in China as per HGRAC policy and the number of slides is defined per HGRAC. **MSD remains responsible for ensuring the subject has not withdrawn consent prior to sample analysis.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-1084-007 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 or unknown slides;Specimen submitted on baked slides;Specimen is a fine needle aspirate (FNA), 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-1084-007 clinical trial. Efficacy of the CDx and MK-1084 will be determined via assessment of PFS per RECIST 1.1 by BICR in participants whose tumors are PD-L1 positive at TPS=1% as defined in the MSD MK-1084-007 Clinical Protocol and Statistical Analysis Plan. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary 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 secondary efficacy endpoint from the MK-1084-007 clinical trial. Efficacy of the CDx and MK-1084 will be determined via assessment of PFS per RECIST 1.1 by BICR in all participants as defined in the MSD MK-1084-007 Clinical Protocol and Statistical Analysis Plan. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactS.J. Johnson
QIAGEN Manchester Limited
Outcome results
None listed