Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
Overview
- Phase
- Phase 3
- Intervention
- Pemetrexed plus Pembrolizumab
- Conditions
- Lung Cancer
- Sponsor
- Hunan Province Tumor Hospital
- Enrollment
- 12000
- Locations
- 1
- Primary Endpoint
- Correlation between Adverse events (AEs) and gene profile
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital
Eligibility Criteria
Inclusion Criteria
- •Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed lung cancer.
- •Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •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.
Arms & Interventions
Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors
Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.
Intervention: Pemetrexed plus Pembrolizumab
Cohort B: Immune Checkpoint Inhibitors monotherapy
Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.
Intervention: Pembrolizumab
Cohort C: Chemotherapy Group.
Lung Cancer patients treated with Chemotherapy.
Intervention: Pemetrexed
Outcomes
Primary Outcomes
Correlation between Adverse events (AEs) and gene profile
Time Frame: Time from first subject dose to study completion, or up to 36 month
Correlation between Adverse events (AEs) and gene profile
Secondary Outcomes
- Correlation between Adverse events (AEs) and survival outcome(Time from first subject dose to study completion, or up to 36 month)
- Adverse events (AEs) rate according to CTCAE 5.0(Time from first subject dose to study completion, or up to 36 month)