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Evaluation for 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

Evaluation for 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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018615
Enrollment
Unknown
Registered
2018-09-30
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Effective group:PD1, TMB and serum cytokines was detected before nivolumab treatment.
Ineffective group:PD1, TMB and serum cytokines was detected before nivolumab treatment.

Sponsors

State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects must be willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of the study; 2. PS > 2, lung cancer in the elderly (less than 65 years old); 3. 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; 4. Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment.

Exclusion criteria

Exclusion criteria: 1. Women with a positive pregnancy test at enrollment or prior to administration of study medication; 2. 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; 3. 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; 4. Other protocol defined inclusion/exclusion criteria could apply.

Design outcomes

Primary

MeasureTime frame
PD-L1 expression levels;PD-L1 expression levels;tumor mutation burden;Serum cytokine levels;Immunotherapy efficacy;

Countries

China

Contacts

Public ContactChengzhi Zhou

State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University

doctorzcz@163.com+86 13560351186

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026