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
Sponsor:
Guangzhou Institute of Respiratory Disease
Collaborators:
Information provided by (Responsible Party):
ShiYue Li，Guangzhou Institute of Respiratory Disease
| Tracking Information | |||
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| First Submitted Date ICMJE | September 25, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | May 1, 2018 | ||
| Estimated Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
PD-L1 expression levels[ Time Frame: before drugs thearpy ] The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry PD-1 expression levels[ Time Frame: before drugs thearpy ] The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry tumor mutation burden[ Time Frame: before drugs thearpy ] Detection of the average number of mutations per megabyte in tumor tissues by NGS Serum cytokine levels[ Time Frame: before drugs thearpy ] Detect the expression level of cytokines in serum Objective Response Rate (ORR) by irRC and RECIST 1.1[ Time Frame: 6 months ] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[ Time Frame: 6 months ] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | 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 |
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| Official Title ICMJE | 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 |
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| 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。 |
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| 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 ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
80 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | March 31, 2019 | ||
| Estimated Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | China | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ShiYue Li，Guangzhou Institute of Respiratory Disease | ||
| Study Sponsor ICMJE | Guangzhou Institute of Respiratory Disease | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Guangzhou Institute of Respiratory Disease | ||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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