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NCT Number: NCT06896422

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Chemotherapy Glutathione Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site PD1 Antibody Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

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)

    Time frame: From the initiation of treatment until 12 weeks

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

Secondary outcomes

  1. Improvement in Immune Parameters

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

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

  2. QLQ-LC43

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

    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.

  3. Overall survival

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Zhang

CONTACT

[email protected]

+86 15138928971

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

Prospective, Randomized Controlled Clinical Trial of Glutathione Combined With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 26, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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