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

NCT06896422 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896422 on ClinicalTrials.gov