Evaluation of Efficacy and Toxicity of Nivolumab Monotherapy for Advanced Non-small Cell Lung Cancer After First-line Treatment Failure Based on Second-generation Sequencing and Liquid Chip Platform

NCT03692442 | Unknown

• 1 other identifier: LCIO
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. The second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。

Conditions

Lung Cancer Non-small Cell Stage IV

Keywords

NGS; cytokine; efficacy; side effect

Outcome Measures

Primary Outcomes (6)

• PD-L1 expression levels

  The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry

  before drugs thearpy

• PD-1 expression levels

  The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry

  before drugs thearpy

• tumor mutation burden

  Detection of the average number of mutations per megabyte in tumor tissues by NGS

  before drugs thearpy

• Serum cytokine levels

  Detect the expression level of cytokines in serum

  before drugs thearpy

• Objective Response Rate (ORR) by irRC and RECIST 1.1

  6 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  6 months

Study Arms (2)

immunotherapy effective group

PD1, TMB and serum cytokines was detected before nivolumab treatment

immunotherapy ineffective group

PD1, TMB and serum cytokines was detected before nivolumab treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advance lung cancer

You may qualify if:

• Subjects must be willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of the study.
• PS \> 2, lung cancer in the elderly (less than 65 years old).
• subjects' characteristics and target disease characteristics Histologically or cytologically diagnosed as NSCLC (SQ or NSQ) and with stage IIIB/IV tumors (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, Version 8) or multimodal therapy (radiotherapy, surgical resection) Subjects who relapsed or developed disease after radical chemoradiotherapy for locally advanced diseases.
• Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatmen

You may not qualify if:

• Women with a positive pregnancy test at enrollment or prior to administration of study medication
• Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
• Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• GeneCast Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，Guangzhou Institute of Respiratory Disease

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 2, 2018
• Study Start: May 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)