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

Sponsor

Sichuan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03373955

Collaborator

Geneplus-Beijing Co. Ltd. (Industry)

Enrollment

Location

49.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 23, 2017

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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