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

Lung Cancer Non-small Cell Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692442
• Other study ID #: LCIO
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: September 2018
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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。

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。

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer Non-small Cell Stage IV
• Lung Neoplasms

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	GeneCast Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD-L1 expression levels	The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry	before drugs thearpy
Primary	PD-1 expression levels	The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry	before drugs thearpy
Primary	tumor mutation burden	Detection of the average number of mutations per megabyte in tumor tissues by NGS	before drugs thearpy
Primary	Serum cytokine levels	Detect the expression level of cytokines in serum	before drugs thearpy
Primary	Objective Response Rate (ORR) by irRC and RECIST 1.1		6 months
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		6 months