RecruitingPhase 3NCT05055908

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


Sponsor

Hunan Province Tumor Hospital

Enrollment

12,000 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.

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.


Locations(1)

Hunan Cancer Hospital

Changsha, Hunan, China

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NCT05055908


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