Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glutathione, PD1 Inhibitor, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer, Chemotherapy, PD1 Antibody, Glutathione. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Randomized Controlled Clinical Trial of Glutathione Combined With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
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.
Interventions
- Drug Glutathione
Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen. - Drug PD1 Inhibitor
e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab - Drug Chemotherapy
Platinum-based doublet chemotherapy
Primary outcome measures
- 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) [Time frame: From the initiation of treatment until 12 weeks]
Secondary outcome measures (3)
- Improvement in Immune Parameters [Time frame: From baseline until 12 weeks post-treatment completion]
- QLQ-LC43 [Time frame: From baseline until 24 weeks post-treatment completion]
- Overall survival [Time frame: From randomization until death from any cause, assessed up to 60 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- the First Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT06896422 · 2024-KY-0017-002