Lung Cancer
Conditions
Brief summary
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.
Detailed description
The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer. Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study. Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.
Interventions
DRUGPemetrexed plus Pembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
DRUGPembrolizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
DRUGPemetrexed
Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed lung cancer. 4. Treated with Immune Checkpoint Inhibitors with or without chemotherapy. 6\. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Exclusion criteria
Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between Adverse events (AEs) and gene profile | Time from first subject dose to study completion, or up to 36 month | Correlation between Adverse events (AEs) and gene profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) rate according to CTCAE 5.0 | Time from first subject dose to study completion, or up to 36 month | Adverse events (AEs) rate according to CTCAE 5.0 |
| Correlation between Adverse events (AEs) and survival outcome | Time from first subject dose to study completion, or up to 36 month | Correlation between Adverse events (AEs) and survival outcome |
Countries
China
Contacts
Primary ContactYongchang Zhang, MD
Backup ContactNong Yang, MD
Outcome results
None listed