Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhengzhou University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Glutathione
- PD1 Inhibitor
- Chemotherapy
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov