Lung CancerNCT05636592
Combined Statin and PD-1/PD-L1 Inhibitors in Treating Non-small Cell Lung Cancer
An observational study of Lung Cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- immunotherapy
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2022to 31 Dec 2027
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to indications of statins, the enrolled people are divided into statin group and non-statin group.
Who may be able to join
- Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy
- Not applicable to EGFR/ALK/ROS1 targeted therapy
- Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements
- Patients have never received PD-1/PD-L1/CTLA-4 inhibitors treatment throughout the body for phase IIIB or IV NSCLC
- Patient have indications for statins
- The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1
- The expected lifetime is more than 12 weeks
- The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or Colony-stimulating factor (CSF) treatment within 14 days prior to the first drug use in this study)
Who cannot join
- Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group
- Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
- Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration
- The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- According to the instructions of statins, there are contraindications to the use of statins
- People who are allergic to any component of the drug
- People with multiple factors affecting oral medicine (such as inability to swallow, gastrointestinal resection, significant digestive system diseases that may interfere with absorption, metabolism or excretion, such as chronic diarrhea or intestinal obstruction)
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Affiliated Hospital of Zhejiang University
Yiwu, Zhejiang, 310000
About this study
Official title: Statin Combined With PD-1/PD-L1 Inhibitors in Treating NSCLC
This prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients. Participants will receive either immunotherapy + statin or immunotherapy until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Read the detailed description
Statin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (CoA) reductase (HMGCR), the rate-limiting enzyme of the mevalonate (MVA) pathway for the cholesterol biosynthesis. Statins reportedly target the immune microenvironment through cytokines or chemokines and immune checkpoints. In a B16 melanoma lung metastatic model, statin lowers PD-1 expression in CD8+ T cells and effectively restores antitumor activity. In colorectal cancers model, simvastatin acts as a potential therapeutic drug for immunotherapy, which suppresses lncRNA SNHG29-mediated YAP activation and promotes anti-tumor immunity by inhibiting PD-L1 expression. Some retrospective observational studies have reported that baseline statin use was associated with improved clinical activity of PD-1/PD-L1 inhibitors in non-small cell lung cancer (NSCLC) patients. These findings support the adjuvant role of statins combined with immunotherapy. Statin therapy may be a combination tool for cancer immunotherapy in patients with NSCLC. Data from already completed clinical trials are not always supportive. These findings should be validated in further prospective studies with larger sample sizes. More clinical trials are needed to explore the right drug type, dose, frequency, duration, and suitable participator. Thus, this prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients.
- Conditions
- Lung Cancer
- Being tested
- immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunotherapyDrug
statin combined with immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Standard programme group | Standard programme group, immunotherapy alone | |
| controlled programme group | controlled programme group, statin combined with immunotherapy Receives: Drug: immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
Measured: three years
progression-free survival
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
Measured: three years
Secondary outcomes (1)
overall survival
The time from randomization to death due to any cause. For subjects who have been lost to follow-up before death, the time of the last follow-up is usually calculated as the time of death.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Oct 2022
- Primary completion31 Dec 2024 (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 Lung CancerStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Wang, PhD, Study chair, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636592
- Sponsor's protocol ID
- K2022145
- Status last verified
- Mar 2024
- First submitted
- 18 Nov 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Combined With PD-1/PD-L1 Inhibitors in Treating NSCLC
- ClinicalTrials.gov ID
- NCT05636592
- Acronym / sponsor ID
- K2022145
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Dec 2022 (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.
This prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients. Participants will receive either immunotherapy + statin or immunotherapy until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Detailed description
Statin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (CoA) reductase (HMGCR), the rate-limiting enzyme of the mevalonate (MVA) pathway for the cholesterol biosynthesis. Statins reportedly target the immune microenvironment through cytokines or chemokines and immune checkpoints. In a B16 melanoma lung metastatic model, statin lowers PD-1 expression in CD8+ T cells and effectively restores antitumor activity. In colorectal cancers model, simvastatin acts as a potential therapeutic drug for immunotherapy, which suppresses lncRNA SNHG29-mediated YAP activation and promotes anti-tumor immunity by inhibiting PD-L1 expression. Some retrospective observational studies have reported that baseline statin use was associated with improved clinical activity of PD-1/PD-L1 inhibitors in non-small cell lung cancer (NSCLC) patients. These findings support the adjuvant role of statins combined with immunotherapy. Statin therapy may be a combination tool for cancer immunotherapy in patients with NSCLC. Data from already completed clinical trials are not always supportive. These findings should be validated in further prospective studies with larger sample sizes. More clinical trials are needed to explore the right drug type, dose, frequency, duration, and suitable participator. Thus, this prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard programme group | – | –Standard programme group, immunotherapy alone |
| controlled programme group | – | Drug: immunotherapycontrolled programme group, statin combined with immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to indications of statins, the enrolled people are divided into statin group and non-statin group.
Key inclusion criteria (8 listed)
- Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy
- Not applicable to EGFR/ALK/ROS1 targeted therapy
- Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements
- Patients have never received PD-1/PD-L1/CTLA-4 inhibitors treatment throughout the body for phase IIIB or IV NSCLC
- Patient have indications for statins
Key exclusion criteria (8 listed)
- Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group
- Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
- Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration
- The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
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 |
|---|---|---|
| immunotherapystatin combined with immunotherapy | Drug | controlled programme group |
Primary outcome
objective response rate
Time frame: three years
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
progression-free survival
Time frame: three years
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
1 secondary outcome
overall survival
Time frame: five years
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 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Kai Wang, PhD study chair
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: three years). 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 12 Mar 2024.