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

Phase 1RecruitingNCT06896422

The First Affiliated Hospital of Zhengzhou University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer Chemotherapy PD1 Antibody Glutathione

Interventions

GlutathioneDRUG

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

PD1 InhibitorDRUG

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

ChemotherapyDRUG

Platinum-based doublet chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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."

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

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

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

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.