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Recruiting Phase 3

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

NCT05055908 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2021-10-01
Last updated
2024-08-02

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

Pemetrexed plus PembrolizumabAll Pemetrexed trials (249) →All Pembrolizumab trials (625) →Pembrolizumab →Pemetrexed →

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

Pembrolizumab: Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.

Pemetrexed: Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Hunan Cancer Hospital Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05055908 on ClinicalTrials.gov ↗ ← All trials in China