Clinical trial · Observational
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
NCT03692442CI-TRIAL-00035110unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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。
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Non-small Cell Stage IV | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- immunotherapy effective group
- description
- PD1, TMB and serum cytokines was detected before nivolumab treatment
- label
- immunotherapy ineffective group
- description
- PD1, TMB and serum cytokines was detected before nivolumab treatment
Primary outcomes (6)
- measure
- PD-L1 expression levels
- timeFrame
- before drugs thearpy
- description
- The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry
- measure
- PD-1 expression levels
- timeFrame
- before drugs thearpy
- description
- The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.