Non-Small Cell Lung CancerPhase 1NCT06896422
Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCLC
A Phase 1 study testing Glutathione, PD1 Inhibitor and Chemotherapy in people with Non-Small Cell Lung Cancer and Chemotherapy, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Chemotherapy, PD1 Antibody
- What is being tested?
- Glutathione, PD1 Inhibitor and Chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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
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
- Non-Small Cell Lung Cancer, Chemotherapy, PD1 Antibody, Glutathione
- Being tested
- Glutathione, PD1 Inhibitor, Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutathioneDrug
Glutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen.
PD1 InhibitorDrug
e.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab
ChemotherapyDrug
Platinum-based doublet chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PD-1 inhibitor plus chemotherapy arm | Placebo comparator | Not described Receives: Drug: PD1 Inhibitor; Drug: Chemotherapy |
| Glutathione combined with PD-1 inhibitor plus chemotherapy arm | Experimental | Not described Receives: Drug: Glutathione; Drug: PD1 Inhibitor; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: 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)
Proportion of patients achieving predefined tumor volume reduction with sustained duration, defined as those attaining a complete response (CR) or partial response (PR).
Measured: From the initiation of treatment until 12 weeks
Secondary outcomes (3)
Improvement in Immune Parameters
assess every 4 weeks via flow cytometry for peripheral CD8+ T-cell proportion and cytokine levels (e.g., IFN-γ, IL-2).
Measured: From baseline until 12 weeks post-treatment completion
QLQ-LC43
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.
Measured: From baseline until 24 weeks post-treatment completion
Overall survival
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.
Measured: From randomization until death from any cause, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896422
- Sponsor's protocol ID
- 2024-KY-0017-002
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06896422
- Acronym / sponsor ID
- 2024-KY-0017-002
- Conditions
- Non-Small Cell Lung Cancer, Chemotherapy, PD1 Antibody, Glutathione
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 inhibitor plus chemotherapy arm | Placebo comparator | Drug: PD1 Inhibitor, Drug: Chemotherapy |
| Glutathione combined with PD-1 inhibitor plus chemotherapy arm | Experimental | Drug: Glutathione, Drug: PD1 Inhibitor, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutathioneGlutathione is administered as an adjunct intervention to the PD-1 inhibitor plus chemotherapy regimen. | Drug | Glutathione combined with PD-1 inhibitor plus chemotherapy arm |
| PD1 Inhibitore.g. pembrolizumab, camrelizumab, sintilimab, tislelizumab, toripalimab | Drug | Glutathione combined with PD-1 inhibitor plus chemotherapy arm, PD-1 inhibitor plus chemotherapy arm |
| ChemotherapyPlatinum-based doublet chemotherapy | Drug | Glutathione combined with PD-1 inhibitor plus chemotherapy arm, PD-1 inhibitor plus chemotherapy arm |
Primary outcome
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
Proportion of patients achieving predefined tumor volume reduction with sustained duration, defined as those attaining a complete response (CR) or partial response (PR).
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glutathione, PD1 Inhibitor and Chemotherapy in people with Non-Small Cell Lung Cancer and Chemotherapy, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (+86 15138928971, yizhang@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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."). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.