Combining Glutathione with Anti-PD-1 and Chemotherapy for Advanced Lung Cancer
Prospective, Randomized Controlled Clinical Trial of Glutathione Combined With PD-1 Antibody and Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
This study is testing if adding glutathione to standard chemotherapy and anti-PD-1 treatment can help people with advanced lung cancer feel better and improve their response to treatment after their disease has progressed.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06896422 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of glutathione in combination with anti-PD-1 therapy and chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). The study aims to determine if glutathione can enhance the immune response and improve treatment efficacy by modulating immune cell dynamics and reducing oxidative stress. Participants will receive glutathione alongside standard chemotherapy and PD-1 inhibitors to assess the potential benefits of this combination therapy. The trial focuses on patients who have experienced disease progression after initial treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed lung squamous cell carcinoma or adenocarcinoma who have shown disease progression after first-line treatment.
Not a fit: Patients with small cell lung cancer or other histological subtypes of lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with advanced NSCLC.
How similar studies have performed: While the combination of glutathione with chemotherapy and immunotherapy is a novel approach, similar studies have shown promise in enhancing immune responses in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zhengzhou, Henan
- the First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Yi Zhang
- Email: yizhang@zzu.edu.cn
- Phone: +86 15138928971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.