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

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。

Study Overview

• Status: Unknown
• Conditions: Lung Cancer Non-small Cell Stage IV

Detailed Description

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。

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Chengzhi Zhou, MD; Phone Number: +8613560351186896; Email: doctorzcz@163.com
      • Principal Investigator: Chengzhi Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

advance lung cancer

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Participants with carcinomatous meningitis Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		6 months
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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Collaborators: GeneCast Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: efficacy; cytokine; NGS; side effect
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LCIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No