Clinical trial NCT03692442: 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
Official title: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer Non-small Cell Stage IV
Keywords: NGS
cytokine
efficacy
side effect
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: GeneCast Biotechnology Co., Ltd.
First posted: 2018-10-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: advance lung cancer

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。

Eligibility criteria: 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

Primary outcomes:
measure: PD-L1 expression levels
timeFrame: before drugs thearpy
measure: PD-1 expression levels
timeFrame: before drugs thearpy
measure: tumor mutation burden
timeFrame: before drugs thearpy
measure: Serum cytokine levels
timeFrame: before drugs thearpy
measure: Objective Response Rate (ORR) by irRC and RECIST 1.1
timeFrame: 6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: