NCT05055908

Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors

Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,000 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed plus Pembrolizumab	Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
DRUG	Pembrolizumab	Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
DRUG	Pemetrexed	Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-07-01
• Completion: 2027-09-14
• First posted: 2021-09-24
• Last updated: 2024-08-02

Locations

1 site across 1 country: China