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

ConditionsNon-Small Cell Lung CancerChemotherapyPD1 AntibodyGlutathione
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Glutathione

    Drug

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

  • PD1 Inhibitor

    Drug

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

  • Chemotherapy

    Drug

    Platinum-based doublet chemotherapy

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: PD-1 inhibitor plus chemotherapy armPlacebo comparator 2 interventions
Group B: Glutathione combined with PD-1 inhibitor plus chemotherapy armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time frame
From randomization until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months."
2

Overall Response Rate (ORR)

Proportion of patients achieving predefined tumor volume reduction with sustained duration, defined as those attaining a complete response (CR) or partial response (PR).

Time frame
From the initiation of treatment until 12 weeks

Secondary outcomes

1

Improvement in Immune Parameters

assess every 4 weeks via flow cytometry for peripheral CD8+ T-cell proportion and cytokine levels (e.g., IFN-γ, IL-2).

Time frame
From baseline until 12 weeks post-treatment completion
2

QLQ-LC43

Quality of Life Questionnaire for Lung Cancer from the European Organization for Research and Treatment of Cancer (EORTC), assessed at baseline, the end of each treatment cycle (every 3 weeks), and at 12 and 24 weeks post-treatment using the Chinese version of the EORTC QLQ-LC43 questionnaire.

Time frame
From baseline until 24 weeks post-treatment completion
3

Overall survival

the time from randomization (or treatment initiation) to death from any cause, serving as the gold-standard endpoint for evaluating long-term therapeutic efficacy in oncology.

Time frame
From randomization until death from any cause, assessed up to 60 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov
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