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

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ClinicalTrials.gov Identifier: NCT03373955
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
Geneplus-Beijing Co. Ltd.
Information provided by (Responsible Party):
You Lu, Sichuan University

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: pembrolizumab

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Constructing Immune Repertoire Using Next-generation Sequencing (NGS) to Monitor the Therapeutic Effect in NSCLC Patients
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Immunotherapy,chemotherapy,radiotherapy
Pembrolizumab will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent.The peripheral blood will be collected at 3 weeks,2 months, 6 months,an average of 1 year
Drug: pembrolizumab
anti-programmed death 1 (PD-1) antibody




Primary Outcome Measures :
  1. T cell repertoire [ Time Frame: 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 Outcome Measures :
  1. peripheral blood circulating tumor DNA [ Time Frame: baseline, 2 months, 6 months, 1 year ]
    peripheral blood was collected at baseline,3 weeks,2 months, 6 months,an average of 1 year


Biospecimen Retention:   Samples With DNA
the investigators will extract Genomic DNA from peripheral blood and extract CtDNA from plasma ASAP.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed of locally advanced or metastatic non small cell lung cancer progressed without previous treatment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373955


Contacts
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Contact: You Lu, MD +8602885423571 radyoulu@hotmali.com
Contact: Ruizhan Tong, MD +8602885423571 sunnyt.r.zhan@163.com

Locations
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China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: You Lu, MD    +8602885423571    radyoulu@hotmail.com   
Contact: Ruizhan Tong, MD    +8602885423571    sunnyt.r.zhan@163.com   
Sponsors and Collaborators
Sichuan University
Geneplus-Beijing Co. Ltd.
Investigators
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Principal Investigator: You Lu, MD West China Hospital
Publications of Results:

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Responsible Party: You Lu, Chair of Department of Thoracic Oncology, Sichuan University
ClinicalTrials.gov Identifier: NCT03373955    
Other Study ID Numbers: GHR-001
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by You Lu, Sichuan University:
T Cell repertoire
lung cancer
tumor mutation burden
Circulating tumour DNA
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents