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
The First Affiliated Hospital of Zhengzhou University
80 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma.
- Documented disease progression following first-line chemotherapy or chemo-immunotherapy.
- Age ≥18 years at the time of enrollment.
Exclusion Criteria3
- Patients with small cell lung cancer or other histological subtypes of lung cancer.
- Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis.
- Pregnant or lactating women
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06896422