Long cancer Non small cell lung cancer (SCLC)
Conditions
Interventions
Intervention in the BO4217 study includes the following treatments:
Divarasib
Sotorasib
Adagrasib
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Tissue inclusion / exclusion criteria: Tumor specimens will be formalin-fixed, paraffin-embedded (FFPE) in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides and should be of good quality, with a minimum of 500 viable tumor cells. Samples collected via resection, core needle biopsy, excisional, incisional, punch, or forceps biopsy, or endobronchial ultrasound (EBUS)-transbronchial needle aspiration are acceptable. Samples that do not preserve tissue architecture, including fine-needle aspiration, brushing, cell pellets from pleural effusion, and lavage samples are not acceptable. Tumor tissue from bone metastases that have been decalcified is not acceptable. Details on the inclusion criteria of the study subjects are described in Section 5.1 of the clinical trial protocol for BO45217
Exclusion criteria
Exclusion criteria: Details on the exclusion criteria of the study subjects are described in Section 5.1 of the clinical trial protocol for BO45217
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the diagnostic performance study is to determine KRAS G12C status in tissues of NSCLC tumors collected from potential study subjects to determine their biomarker eligibility for study BO45217. Currently, there is no plan for the therascreen® KRAS RGQ PCR Kit to be further developed as a companion diagnostic based on the results of study BO45217. As such, there are no separate, independent endpoints specified to be evaluated for the use of the assay in the clinical performance study beyond the BO45217 trial objectives evaluating the clinical safety and efficacy of the biomarker-selected treatments. | — |
Countries
Netherlands
Outcome results
None listed