Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Conditions

Adenocarcinoma of Lung, Lung Cancer, Nonsmall Cell, Lung Neoplasms, Squamous Cell Lung Cancer

Keywords

Next Generation Sequencing (NGS), Tyrosine Kinase Inhibitor (TKI), liquid biopsy, EGFR Gene mutation

Brief summary

To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

Detailed description

In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

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10.3389/fimmu.2022.1074906

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Xinghao Ai, Jiuwei Cui, Jiexia Zhang, Rongrong Chen, Wen Lin et al. (19 authors)

Clinical Cancer Research2020-11-1339 citations

10.1158/1078-0432.ccr-20-3063

Clonal dominance of EGFR and efficacy of EGFR-tyrosine kinase inhibitors (EGFR-TKIs) in NSCLC.

Xinghao Ai, Rongrong Chen, Jiuwei Cui, Jiexia Zhang, Wen Lin et al. (15 authors)

Journal of Clinical Oncology2020-05-201 citations

10.1200/jco.2020.38.15_suppl.e21501

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

* Provision of informed consent * Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively * ECOG performance status 0-2 with expected more than 6 months of survival time * Willingness to comply with required protocols and give permission to use the data for clinical research and products development

Exclusion criteria

* Patients have other primary cancers * Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders * Patients failed in either plasma or tissue sample QC

Design outcomes

Primary

Measure	Time frame
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.	2 years

Secondary

Measure	Time frame
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.	1 year

Countries

China

Outcome results