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

NCT06896422 | Recruiting Phase 1

• 1 other identifier: 2024-KY-0017-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Non-Small Cell Lung Cancer; Chemotherapy; PD1 Antibody; Glutathione

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

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

• 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).

  From the initiation of treatment until 12 weeks

Secondary Outcomes (3)

• Improvement in Immune Parameters

  From baseline until 12 weeks post-treatment completion

• QLQ-LC43

  From baseline until 24 weeks post-treatment completion

• Overall survival

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

Study Arms (2)

PD-1 inhibitor plus chemotherapy arm

PLACEBO COMPARATOR

Drug: PD1 Inhibitor; Drug: Chemotherapy

Glutathione combined with PD-1 inhibitor plus chemotherapy arm

EXPERIMENTAL

Drug: Glutathione; Drug: PD1 Inhibitor; Drug: Chemotherapy

Interventions

Glutathione DRUG

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

Glutathione combined with PD-1 inhibitor plus chemotherapy arm

PD1 Inhibitor DRUG

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

Glutathione combined with PD-1 inhibitor plus chemotherapy arm; PD-1 inhibitor plus chemotherapy arm

Chemotherapy DRUG

Platinum-based doublet chemotherapy

Glutathione combined with PD-1 inhibitor plus chemotherapy arm; PD-1 inhibitor plus chemotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Glutathione; Immune Checkpoint Inhibitors; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Central Study Contacts

Yi Zhang

CONTACT

+86 15138928971; yizhang@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biotherapy Center

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)