Clinical trial · Interventional
Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC
Prospective, Randomized Controlled Clinical Trial of Glutathione Combined With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Glutathione | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| PD1 Antibody | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Glutathione | Drug | — | UNRESOLVED |
| PD1 Inhibitor | Drug | PD1 Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- PD-1 inhibitor plus chemotherapy arm
- interventionNames
- Drug: PD1 Inhibitor
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Glutathione combined with PD-1 inhibitor plus chemotherapy arm
- interventionNames
- Drug: Glutathione
- Drug: PD1 Inhibitor
- Drug: Chemotherapy
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From randomization until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months."
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available