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

Zhengzhou University

Status and phase: Enrolling; Phase 1

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06896422

2024-KY-0017-002

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

PD-1 inhibitor plus chemotherapy arm

Placebo Comparator group

Treatment:

Drug: Chemotherapy

Drug: PD1 Inhibitor

Glutathione combined with PD-1 inhibitor plus chemotherapy arm

Experimental group

Treatment:

Drug: Chemotherapy

Drug: PD1 Inhibitor

Drug: Glutathione