Lung Cancer Non-small Cell Stage IV
Conditions
Keywords
NGS, cytokine, efficacy, side effect
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。
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。
Interventions
None listed
Sponsors
GeneCast Biotechnology Co., Ltd.
Guangzhou Institute of Respiratory Disease
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD-L1 expression levels | before drugs thearpy | The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry |
| PD-1 expression levels | before drugs thearpy | The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry |
| tumor mutation burden | before drugs thearpy | Detection of the average number of mutations per megabyte in tumor tissues by NGS |
| Serum cytokine levels | before drugs thearpy | Detect the expression level of cytokines in serum |
| 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 | — |
Countries
China
Outcome results
None listed