RecruitingPhase 1NCT06896422

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


Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

80 participants

Start Date

Jun 1, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding glutathione — a powerful natural antioxidant — to standard immunotherapy (an anti-PD-1 drug) and chemotherapy can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) whose cancer has progressed after initial treatment. The idea is that glutathione may help the immune system work better against cancer and reduce treatment side effects. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced lung cancer (squamous cell carcinoma or adenocarcinoma, confirmed by biopsy) - Your cancer has grown or spread after receiving first-line chemotherapy or chemo-immunotherapy - You are well enough to receive further treatment **You may NOT be eligible if...** - You have small cell lung cancer or another type of lung cancer (other than squamous or adenocarcinoma) - You have been lost to prior follow-up or cannot commit to study visits - You have serious organ problems that would make chemotherapy or immunotherapy unsafe - You are pregnant or breastfeeding - You are currently enrolled in another clinical trial for lung cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlutathione

Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen.

DRUGPD1 Inhibitor

e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab

DRUGChemotherapy

Platinum-based doublet chemotherapy


Locations(1)

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06896422


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