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Recruiting Phase 1 NCT06896422

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

Trial Parameters

Condition Non-Small Cell Lung Cancer
Sponsor The First Affiliated Hospital of Zhengzhou University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-01
Completion 2026-12-31
Interventions
GlutathionePD1 InhibitorChemotherapy

Brief 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 Criteria

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma. 2. Documented disease progression following first-line chemotherapy or chemo-immunotherapy. 3. Age ≥18 years at the time of enrollment. Exclusion Criteria: 1. Patients with small cell lung cancer or other histological subtypes of lung cancer. 2. Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis. 3. Pregnant or lactating women

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