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

Study Overview
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Brief Summary
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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。

Detailed Description
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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。

Official Title
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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

Conditions
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Lung Cancer Non-small Cell Stage IV

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| immunotherapy effective group<br>PD1, TMB and serum cytokines was detected before nivolumab treatment | |
| immunotherapy ineffective group<br>PD1, TMB and serum cytokines was detected before nivolumab treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NGS, cytokine, efficacy, side effect