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

Phase 1

Recruiting

• Conditions: Non-Small Cell Lung Cancer; Chemotherapy; PD1 Antibody; Glutathione
• Interventions: Drug: PD1 Inhibitor; Drug: Glutathione; Drug: Chemotherapy

• Registration Number: NCT06896422
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study Start: 2025-03-21
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma.
2. Documented disease progression following first-line chemotherapy or chemo-immunotherapy.
3. Age ≥18 years at the time of enrollment.

Exclusion Criteria

1. Patients with small cell lung cancer or other histological subtypes of lung cancer.
2. Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis.
3. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD-1 inhibitor plus chemotherapy arm	PD1 Inhibitor	-
PD-1 inhibitor plus chemotherapy arm	Chemotherapy	-
Glutathione combined with PD-1 inhibitor plus chemotherapy arm	Glutathione	-
Glutathione combined with PD-1 inhibitor plus chemotherapy arm	PD1 Inhibitor	-
Glutathione combined with PD-1 inhibitor plus chemotherapy arm	Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
Improvement in Immune Parameters	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).
Overall survival	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.
QLQ-LC43	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.

Trial Locations

Locations (1)

the First Affiliated Hospital of Zhengzhou University; 🇨🇳 ZhengZhou, Henan, China