ArticleLung cancer (Amsterdam, Netherlands)2022
Clinical validation of Guardant360 CDx as a blood-based companion diagnostic for sotorasib.
Article in Lung cancer (Amsterdam, Netherlands), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03600833, which is not on this map. Cited by 54 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Who cites it
54 citing papers in PubMed, 2 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Diagnostic accuracy of next-generation sequencing (NGS) for identifying actionable mutations in advanced non-small cell lung cancer: Systematic Review and Meta-Analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Pooled it
- Detection ofFrontiers in oncology · 2023Pooled it
- Review
- The role of serologic biomarkers "liquid biopsy" in the fight against breast cancer: From biological foundations to clinical impact.iScience · 2026Review
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- Variant allele frequency as a potential marker in response to frontline systemic therapy for patients with locally advanced and metastatic urothelial carcinoma.Translational andrology and urology · 2026Article
- USP44, ZNF454, and GPRC5B ctDNA Methylation Markers in Breast Cancer: Limited Clinical Relevance for Disease Monitoring and Tumor Characteristics.Asia-Pacific journal of clinical oncology · 2026Article
- Early Cancer Detection: What's Going on and What's Next.MedComm · 2026Review
- Companion Diagnostics in Clinical Therapy: Current Applications and Future Directions.MedComm · 2026Review
- The Current Status of Circulating Tumor DNA Utilization in Australasia: A Survey of Thoracic Oncology Group Australasia Members.Asia-Pacific journal of clinical oncology · 2026Article
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- Case Report: A case series on actionable genomic alterations guiding effective targeted therapy in rare sarcomas.Frontiers in oncology · 2026Article
- Genomic innovations in cancer prevention, diagnosis, prognosis and precision therapeutics.Frontiers in genetics · 2026Review
- Liquid biopsies for detection, characterization, and interception of therapy resistance in thoracic malignancies.Frontiers in oncology · 2026Review
- Multi-omics biomarkers for predicting resistance, hyperprogression, and immune-related toxicity during PD-1/PD-L1 therapy in lung cancer: a literature review.Frontiers in immunology · 2026Review
- Multi-Biofluid Approaches for cftDNA and cftRNA Biomarker Detection: Advances in Early Cancer Detection and Monitoring.Current issues in molecular biology · 2025Review
- Extracellular vesicles: biogenesis mechanism and impacts on tumor immune microenvironment.Journal of biomedical science · 2025Review
- Integrating ctDNA testing forAdvances in laboratory medicine · 2025Review
- Recent advances in liquid biopsy for precision oncology: emerging biomarkers and clinical applications in lung cancer.Future oncology (London, England) · 2025Review
- Article
Corrections and comments
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Authors and funding
14 authors at 10 institutions in 4 countries.
Funding
Abstract
objectivesEffective therapy for non-small-cell lung cancer (NSCLC) depends on morphological and genomic classification, with comprehensive screening for guideline-recommended biomarkers critical to guide treatment. Companion diagnostics, which provide robust genotyping results, represent an important component of personalized oncology. We evaluated the clinical validity of Guardant360 CDx as a companion diagnostic for sotorasib for detection of KRAS p.G12C, an important oncogenic NSCLC driver mutation. MATERIALS AND
methodsKRAS p.G12C was tested in NSCLC patients from CodeBreaK100 (NCT03600833) in pretreatment plasma samples using Guardant360 CDx liquid biopsy and archival tissue samples using therascreen® KRAS RGQ polymerase chain reaction (PCR) kit tissue testing. Matched tissue and plasma samples were procured from other clinical trials or commercial vendors, and results were compared. Demographics and clinical characteristics and objective response rate (ORR) were evaluated.
resultsOf 126 CodeBreaK patients, 112 (88.9%) were tested for KRASp.G12C mutations with Guardant360 CDx. Among 189 patients in the extended analysis cohort, the positive and negative percent agreement (95% CI) for Guardant360 CDx plasma testing relative to therascreen® KRAS RGQ PCR kit tissue testing were 0.71 (0.62, 0.79) and 1.00 (0.95, 1.00), respectively; overall percent agreement (95% CI) was 0.82 (0.76, 0.87). TP53 co-mutations were the most common regardless of KRAS p.G12C status (KRAS p.G12C-positive, 53.4%; KRAS p.G12C-negative, 45.5%). STK11 was co-mutated in 26.1% of KRAS p.G12C-positive samples. The ORR was similar among patients selected by plasma and tissue testing.
conclusionComprehensive genotyping for all therapeutic targets including KRAS p.G12C is critical for management of NSCLC. Liquid biopsy using Guardant360 CDx has clinical validity for identification of patients with KRASp.G12C-mutant NSCLC and, augmented by tissue testing methodologies as outlined on the approved product label, will identify patients for treatment with sotorasib.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.