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TEST:
Guardant360® CDx

Related tests:
10d
NCI-2017-00831: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (clinicaltrials.gov)
P2, N=93, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation
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FoundationOne® CDx • Guardant360® CDx • cobas® EGFR Mutation Test v2 • therascreen® EGFR RGQ PCR Kit
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Pozenveo (poziotinib)
10d
Enrollment change • Trial completion date
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BRAF V600E • BRAF V600 • BRAF V600K • EZH2 mutation
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Guardant360® CDx
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Mekinist (trametinib) • Tafinlar (dabrafenib) • Tazverik (tazemetostat)
16d
G360-IIT: Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy (clinicaltrials.gov)
P2, N=108, Recruiting, Hackensack Meridian Health | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
Trial completion date • Trial primary completion date • Circulating tumor DNA
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx • Guardant360® CDx
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Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
1m
BRICKET: Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC (clinicaltrials.gov)
P2, N=16, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Recruiting --> Active, not recruiting
Enrollment closed • Circulating tumor DNA
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
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BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
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Guardant360® CDx
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Erbitux (cetuximab) • Braftovi (encorafenib)
2ms
Clinical Feasibility of Circulating Tumor DNA in Patients with Advanced Hepatocellular Carcinoma Treated with Atezolizumab plus Bevacizumab. (PubMed, Liver Cancer)
Additionally, ctDNA maxVAF demonstrated independent prognostic value in patients treated with first-line atezo/bev. Liquid biopsy using ctDNA can help address challenges associated with limited tissue-based genomic profiling in advanced HCC.
Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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Guardant360® CDx
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Avastin (bevacizumab) • Tecentriq (atezolizumab)
2ms
Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, National Cancer Institute (NCI) | N=85 --> 22 | Trial completion date: Jun 2026 --> Nov 2026 | Trial primary completion date: Jun 2026 --> Nov 2025
Enrollment change • Trial completion date • Trial primary completion date
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • KEAP1 (Kelch Like ECH Associated Protein 1) • NFE2L2 (Nuclear Factor, Erythroid 2 Like 2)
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BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • BRAF V600K • KEAP1 mutation • NFE2L2 mutation
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Guardant360® CDx • MSK-IMPACT
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sapanisertib (CB-228) • telaglenastat (CB-839)
3ms
Variability of Circulating Tumor DNA Levels in Plasma Samples From Patients With Advanced Non-Small-Cell Lung Cancer in the Absence of Treatment. (PubMed, JCO Precis Oncol)
Intrapatient ctDNA variability over time in EGFR-mutant advanced NSCLC includes changes that may confound interpretation of treatment activity, depending on the magnitude of change used to indicate molecular response. These findings demonstrate that evaluation of on-treatment changes must account for potential background variability, including technical variability because of factors such as cfDNA input level and tumor-related VAF, and that baseline samples should be obtained as close as possible to treatment initiation to minimize the impact of background variability.
Journal • Circulating tumor DNA
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Guardant360® CDx • GuardantOMNI
3ms
The Prognostic and Predictive Impact of Circulating Tumour DNA Levels in Patients with Advanced Breast Cancer Enrolled on the plasmaMATCH Trial. (PubMed, Clin Cancer Res)
Baseline low ctDNA levels predict response to targeted therapy, potentially suggesting shared mechanisms between high ctDNA release and resistance to therapy. Both baseline ctDNA levels and on-treatment dynamics are a promising surrogate endpoint for drug development, with clearance of ctDNA being a robust cross-therapy surrogate for outcome.
Journal • BRCA Biomarker • PARP Biomarker • Circulating tumor DNA
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PALB2 (Partner and localizer of BRCA2)
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Guardant360® CDx • GuardantOMNI
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Lynparza (olaparib) • ceralasertib (AZD6738)
3ms
Enrollment closed
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BRAF V600E • BRAF V600 • BRAF V600K • EZH2 mutation
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Guardant360® CDx
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Mekinist (trametinib) • Tafinlar (dabrafenib) • Tazverik (tazemetostat)
4ms
Evolution of Potentially Actionable Genomic Alterations in Advanced Prostate Cancer: A Real-World Analysis of Serial Circulating Tumor DNA Testing. (PubMed, Cancers (Basel))
In a Mayo Clinic subset, ten patients received olaparib based on treatment-emergent alterations, but none achieved a prostate-specific antigen (PSA) response. Two patients who transitioned from low to high TMB received pembrolizumab, both with progressive disease as best response. In a large real-world cohort, serial ctDNA testing frequently identified new alterations that were not detected at baseline and are potentially actionable therapeutic targets, highlighting the value of serial genomic profiling for capturing clonal dynamics. Additional research is needed to better establish a framework for retesting and to clarify how these results should influence subsequent treatment decisions.
Journal • Real-world evidence • Tumor mutational burden • PARP Biomarker • PD(L)-1 Biomarker • Circulating tumor DNA
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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TMB-H
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Guardant360® CDx
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Keytruda (pembrolizumab) • Lynparza (olaparib)
5ms
A compilation of 13 patients with metastatic colorectal cancer and concomitant BRAF and RAS family mutations. (PubMed, Front Oncol)
Median time from diagnosis of stage IV disease to progression was 25.3 months and median overall survival was 4.9 years. This study adds more insight to the limited existing data regarding rare mCRC cases with concomitant BRAF and RAS family mutations and exposes the need for future research on larger populations of this rare subset of patients.
Journal
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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BRAF V600E • KRAS mutation • BRAF mutation • NRAS mutation • BRAF V600 • RAS mutation
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Guardant360® CDx
5ms
Circulating Tumor DNA Profiling Reveals Genomic Evolution in Recurrent Gastric or Gastroesophageal Junction Cancer. (PubMed, Mol Diagn Ther)
A circulating tumor DNA analysis effectively captured genomic evolution at recurrence, identifying clinically relevant alterations not found in primary tumor tissue. These findings support the integration of a liquid biopsy into clinical practice to guide treatment for recurrent gastric or gastroesophageal junction cancer.
Journal • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • ATM (ATM serine/threonine kinase) • ARID1A (AT-rich interaction domain 1A)
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HER-2 amplification • PIK3CA mutation • ATM mutation • ARID1A mutation
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Guardant360® CDx