Actively Recruiting
Randomized Controlled Trial of Glutathione With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-08-07
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether glutathione can improve the effectiveness of current chemo-immunotherapy treatments for advanced non-small cell lung cancer (NSCLC). The study explores how different chemotherapy sequences affect immune cells within tumors and how glutathione may modulate the immune response to enhance treatment outcomes and patient survival. This is a phase 1 randomized controlled trial led by The First Affiliated Hospital of Zhengzhou University. Participants will receive either a combination of a PD-1 inhibitor and platinum-based doublet chemotherapy alone or the same regimen with added glutathione. The PD-1 inhibitors used include pembrolizumab, camrelizumab, sintilimab, tislelizumab, or toripalimab. Glutathione is administered as an adjunct drug to evaluate its impact on chemo-immunotherapy. The study compares these two groups to assess differences in treatment response and immune system effects. Throughout the trial, participants will be monitored for progression-free survival up to 24 months and overall response rate within 12 weeks after starting treatment. Additional assessments include immune system parameters, quality of life scores up to 24 weeks, and overall survival up to 60 months. The study involves regular evaluations to measure disease progression, immune function, and patient well-being to understand how glutathione influences treatment outcomes and safety.
CONDITIONS
Brief Title
Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older at the time of enrollment
You will not qualify if you...
- Diagnosis of small cell lung cancer or other lung cancer subtypes
- Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants receive glutathione combined with PD-1 inhibitor plus chemotherapy or PD-1 inhibitor plus chemotherapy alone as part of the intervention.
Duration - Up to 60 months
Participants are monitored for progression-free survival, overall response, immune parameters, quality of life, and overall survival after treatment completion.
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Y
Yi Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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