Adenocarcinoma of Lung, Lung Cancer, Nonsmall Cell, Lung Neoplasms, Squamous Cell Lung Cancer
Conditions
Keywords
Next Generation Sequencing (NGS), Liquid biopsy, Immune Checkpoint Inhibitor, Whole Transcriptome Sequencing
Brief summary
To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.
Detailed description
In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.
Interventions
OTHERObservation
observe the association of ctDNA with efficacy of treatment
Sponsors
Geneplus-Beijing Co. Ltd.
Shanghai Chest Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or 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 * No EGFR mutation in tissue and ctDNA * Received immune checkpoint inhibitors as the first line therapy * 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 | Description |
|---|---|---|
| the evolution of ctDNA mutation profile during treatment | every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days) | ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resistant mechanisms of targeted therapy | At the time of disease progression (through study completion, an average of 1.5 years) | Resistant mutations will be identified from ctDNA or tissue mutations |
Countries
China
Outcome results
None listed