NCT06896422

Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC

Prospective, Randomized Controlled Clinical Trial of Glutathione Combined With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-Small Cell Lung Cancer
• Chemotherapy
• PD1 Antibody
• Glutathione

Interventions

Type	Name	Description
DRUG	Glutathione	Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen.
DRUG	PD1 Inhibitor	e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab
DRUG	Chemotherapy	Platinum-based doublet chemotherapy

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-03-26
• Last updated: 2025-08-07

Locations

1 site across 1 country: China