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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer Chemotherapy PD1 Antibody Glutathione

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PD-1 inhibitor plus chemotherapy arm

Group Type PLACEBO_COMPARATOR

PD1 Inhibitor

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Platinum-based doublet chemotherapy

Glutathione combined with PD-1 inhibitor plus chemotherapy arm

Group Type EXPERIMENTAL

Glutathione

Intervention Type DRUG

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

PD1 Inhibitor

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Platinum-based doublet chemotherapy

Interventions

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Glutathione

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

Intervention Type DRUG

PD1 Inhibitor

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

Intervention Type DRUG

Chemotherapy

Platinum-based doublet chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No