Clinical trial NCT03373955: A Prospective Study of Constructing Immune Repertoire to Monitor the Therapeutic Effect in NSCLC Patients
Official title: A Prospective Study of Constructing Immune Repertoire Using Next-generation Sequencing (NGS) to Monitor the Therapeutic Effect in NSCLC Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: T Cell repertoire
lung cancer
tumor mutation burden
Circulating tumour DNA
Lead sponsor: Sichuan University
Sponsor class: OTHER
Collaborators: name: Geneplus-Beijing Co. Ltd.
First posted: 2017-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed of locally advanced or metastatic non small cell lung cancer progressed without previous treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: T cell repertoire
timeFrame: baseline, 2 months, 6 months, 1 year
Secondary outcomes:
measure: peripheral blood circulating tumor DNA
timeFrame: baseline, 2 months, 6 months, 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: You Lu, MD
role: PRINCIPAL_INVESTIGATOR
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