Non-small Cell Lung Cancer
Conditions
Keywords
T Cell repertoire, lung cancer, tumor mutation burden, Circulating tumour DNA
Brief summary
This study is designed to evaluate the untreated NSCLC patients. After participants have accepted chemotherapy, radiotherapy, and immunotherapy, the investigators used the next generation sequence technology (NGS) to construct immune repertoire to detective variation of patients' immune state and to monitor patients' therapeutic effect. The investigators are aim to explore the novel clone sequence as potential therapy target.
Detailed description
Lung cancer was one of the most deadly tumors in the world. The standard of care for patients is platinum-based doublet chemotherapy concurrent with radiotherapy. As for patients with a mutant epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase(ALK), EGFR or ALK tyrosine kinase inhibitors (TKIs) are the standard first-line therapy. Now, the Food and Drug Administration approved Ipilimumab, Nivolumab, and Pembrolizumab as first-line or second-line therapy for NSCLC. However, there was no reports about therapeutic effect for NSCLC patients through detecting herself immune state, immune repertoire could explore patients' immune clonality and diversity using NGS technology.The investigators look forward to illuminate the mechanism of patients antitumor action.
Interventions
DRUGpembrolizumab
anti-programmed death 1 (PD-1) antibody
Sponsors
Geneplus-Beijing Co. Ltd.
Sichuan University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Pathologically verified stage IV non-small cell lung cancer without treated. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Major organs function normally * Women at pregnant ages should be under contraception * Willing and able to provide informed consent
Exclusion criteria
* Pathology is mixed type• * Poor vasculature * Coagulopathy, or ongoing thrombolytics and/or anticoagulation * Blood-borne infectious disease, e.g. hepatitis B * History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician * Other conditions requiring exclusion deemed by physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T cell repertoire | baseline, 2 months, 6 months, 1 year | peripheral blood was collected at baseline,3 weeks,2 months, 6 months,an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peripheral blood circulating tumor DNA | baseline, 2 months, 6 months, 1 year | peripheral blood was collected at baseline,3 weeks,2 months, 6 months,an average of 1 year |
Countries
China
Contacts
Primary ContactYou Lu, MD
Backup ContactRuizhan Tong, MD
Outcome results
None listed