Non-Small Cell Lung Cancer, Chemotherapy, PD1 Antibody, Glutathione
Conditions
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.
Interventions
DRUGGlutathione
Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen.
DRUGPD1 Inhibitor
e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab
DRUGChemotherapy
Platinum-based doublet chemotherapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYi Zhang
Outcome results
None listed