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

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: pembrolizumab

• Registration Number: NCT03373955
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-23
• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-12-10
• Study First Posted: 2017-12-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-18
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy,chemotherapy,radiotherapy	pembrolizumab	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China