A Phase 1 interventional study of Glutathione and PD1 Inhibitor in Non-Small Cell Lung Cancer, Chemotherapy and PD1 Antibody, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 1, Interventional, and Prevention
Chemotherapeutic agents exert significant immunomodulatory effects by influencing tumor-infiltrating immune cells. However, the sequence and combination of chemotherapy regimens differentially modulate immune cell dynamics, ultimately impacting treatment efficacy and patient survival. Glutathione, a critical bioactive molecule, demonstrates broad potential in tumor immunotherapy. Through mechanisms such as scavenging free radicals, modulating immune cell proliferation and differentiation, and regulating cytokine expression, glutathione achieves precise modulation of immune responses to enhance immune system functionality. To investigate whether glutathione can enhance the clinical efficacy of current chemo-immunotherapy regimens in non-small cell lung cancer (NSCLC), investigators conducted this clinical study.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 80 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PD1 Inhibitor · Drug: Chemotherapy
Drug: Glutathione · Drug: PD1 Inhibitor · Drug: Chemotherapy
Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen.
e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab
Platinum-based doublet chemotherapy
Progression-Free Survival (PFS)
Time frame: From randomization until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months."
Overall Response Rate (ORR)
Proportion of patients achieving predefined tumor volume reduction with sustained duration, defined as those attaining a complete response (CR) or partial response (PR).
Time frame: From the initiation of treatment until 12 weeks
Improvement in Immune Parameters
assess every 4 weeks via flow cytometry for peripheral CD8+ T-cell proportion and cytokine levels (e.g., IFN-γ, IL-2).
Time frame: From baseline until 12 weeks post-treatment completion
QLQ-LC43
Quality of Life Questionnaire for Lung Cancer from the European Organization for Research and Treatment of Cancer (EORTC), assessed at baseline, the end of each treatment cycle (every 3 weeks), and at 12 and 24 weeks post-treatment using the Chinese version of the EORTC QLQ-LC43 questionnaire.
Time frame: From baseline until 24 weeks post-treatment completion
Overall survival
the time from randomization (or treatment initiation) to death from any cause, serving as the gold-standard endpoint for evaluating long-term therapeutic efficacy in oncology.
Time frame: From randomization until death from any cause, assessed up to 60 months.
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
The First Affiliated Hospital of Zhengzhou University