A Prospective Study of Constructing Immune Repertoire to Monitor the Therapeutic Effect in NSCLC Patients

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    60
  • sponsor
    Sichuan University
Updated on 28 March 2021
pembrolizumab
cancer chemotherapy
stage iv non-small cell lung cancer
lung carcinoma

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.

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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Pembrolizumab
Clinical Study IdentifierNCT03373955
SponsorSichuan University
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

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
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