Lung CancerPhase 1NCT05735028
The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
A Phase 1 study testing Centipeda minima+PD-1/PD-L1 inhibitor and PD-1/PD-L1 inhibitor in people with Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Lung cancer has a high global cancer morbidity and mortality. At present, PD-1/PD-L1 inhibitors have been approved by FDA to treat different types of lung cancer, but the efficacy is not good. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Centipeda minima+PD-1/PD-L1 inhibitor and PD-1/PD-L1 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2024to 7 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-small cell lung cancer diagnosed by histopathology and intended to be treated with PD-1/PD-L1 inhibitors alone meet the following conditions:
- Patients fully understand this study and voluntarily participate in and sign informed consent.
- Patients with non-small cell lung cancer (NSCLC) confirmed by histopathology will be treated with PD-1/PD-L1 alone.
- 18-70 years old, and the expected survival time is more than 6 months.
- The indexes of stool routine are normal.
Who cannot join
- Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period.
- Those who are hypersensitive to any research drugs or ingredients
- Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed.
- Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on.
- Those who have participated in clinical trials of other drugs within 5 or 4 weeks.
- Patients with severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease and intractable hypertension.
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- Suffering from uncontrollable neurological, mental illness or mental disorders, poor compliance, unable to cooperate and describe the treatment response. Primary brain tumor or central nervous system metastasis is not controlled, with obvious intracranial hypertension or neuropsychiatric symptoms.
- Those with bleeding tendency; evidence of hereditary hemorrhagic physique or blood coagulation disorder
- Severe allergic / allergic reaction to humanized antibody.
- Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (prednisone or equivalent for ≤ 10mg/ days).
- Exclude subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes).
- Vulnerable groups: such as patients with serious diseases, incapacitated, illiterate, mentally retarded / related mental disorders, children.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Ying Dong
About this study
Official title: A Preliminary Study on the Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
Lung cancer has a high global cancer morbidity and mortality. At present, PD-1/PD-L1 inhibitors have been approved by FDA to treat different types of lung cancer, but the efficacy is not good. There is an urgent need to develop drugs that can significantly enhance the efficacy of PD-1/PD-L1 inhibitors to enable tumor patients to obtain lasting anti-tumor response. Centipeda minima (CM), as a commonly used traditional Chinese medicine, is relatively safe. Previous studies found that it can inhibit the growth of lung cancer cells. At the level of animal research, the combined use of CM and PD-1/PD-L1 inhibitors produced a stronger anti-lung cancer effect, and did not produce obvious side effects on mice. Based on previous studies, the main purpose of this study was to evaluate the efficacy and safety of PD-1/PD-L inhibitors combined with herbivorous herbivores (CM) in the treatment of lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Centipeda minima+PD-1/PD-L1 inhibitor, PD-1/PD-L1 inhibitor
- Keywords
- lung cancer, Centipeda minima, efficacy, safty
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centipeda minima+PD-1/PD-L1 inhibitorDrug
Before routine anti-PD-1/PD-L1 treatment, patients were treated with Centipeda minima, and15g Centipeda minima decoction was taken twice a day for 5 consecutive days.
PD-1/PD-L1 inhibitorDrug
PD-1/PD-L1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| CM group | Experimental | CM+PD-1/PD-L1 inhibitor Receives: Drug: Centipeda minima+PD-1/PD-L1 inhibitor |
| Control group | Active comparator | PD-1/PD-L1 inhibitor Receives: Drug: PD-1/PD-L1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival
Measured: through study completion, an average of 2 year.
the temperature
Vital signs
Measured: through study completion, an average of 2 year.
blood pressure
Vital signs
Measured: through study completion, an average of 2 year.
complete blood count
laboratory index
Measured: through study completion, an average of 2 year.
adverse event and severe adverse event
adverse event and severe adverse event, according to NCI-CTC V5.0
Measured: through study completion, an average of 2 year.
Secondary outcomes (2)
Objective Response Rate (ORR)
Objective Response Rate
Measured: through study completion, an average of 2 year.
disease control rate (DCR)
disease control rate
Measured: through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Feb 2024
- Primary completion7 Aug 2025 (estimated)
- Study completion7 Dec 2025 (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 Second Affiliated Hospital, 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Dong, Doctorate, Principal investigator, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735028
- Sponsor's protocol ID
- 2022-0826
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2023
- Last updated
- 17 Apr 2024
- Results posted
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
- ClinicalTrials.gov ID
- NCT05735028
- Acronym / sponsor ID
- 2022-0826
- Conditions
- Lung Cancer
- Keywords
- lung cancer, Centipeda minima, efficacy, safty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Aug 2025 (estimated)
- Study completion
- 7 Dec 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
Lung cancer has a high global cancer morbidity and mortality. At present, PD-1/PD-L1 inhibitors have been approved by FDA to treat different types of lung cancer, but the efficacy is not good. There is an urgent need to develop drugs that can significantly enhance the efficacy of PD-1/PD-L1 inhibitors to enable tumor patients to obtain lasting anti-tumor response. Centipeda minima (CM), as a commonly used traditional Chinese medicine, is relatively safe. Previous studies found that it can inhibit the growth of lung cancer cells. At the level of animal research, the combined use of CM and PD-1/PD-L1 inhibitors produced a stronger anti-lung cancer effect, and did not produce obvious side effects on mice. Based on previous studies, the main purpose of this study was to evaluate the efficacy and safety of PD-1/PD-L inhibitors combined with herbivorous herbivores (CM) in the treatment of lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM group | Experimental | Drug: Centipeda minima+PD-1/PD-L1 inhibitorCM+PD-1/PD-L1 inhibitor |
| Control group | Active comparator | Drug: PD-1/PD-L1 inhibitorPD-1/PD-L1 inhibitor |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-small cell lung cancer diagnosed by histopathology and intended to be treated with PD-1/PD-L1 inhibitors alone meet the following conditions:
- Patients fully understand this study and voluntarily participate in and sign informed consent.
- Patients with non-small cell lung cancer (NSCLC) confirmed by histopathology will be treated with PD-1/PD-L1 alone.
- 18-70 years old, and the expected survival time is more than 6 months.
- The indexes of stool routine are normal.
Key exclusion criteria (13 listed)
- Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period.
- Those who are hypersensitive to any research drugs or ingredients
- Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed.
- Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on.
- Those who have participated in clinical trials of other drugs within 5 or 4 weeks.
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 |
|---|---|---|
| Centipeda minima+PD-1/PD-L1 inhibitorBefore routine anti-PD-1/PD-L1 treatment, patients were treated with Centipeda minima, and15g Centipeda minima decoction was taken twice a day for 5 consecutive days. | Drug | CM group |
| PD-1/PD-L1 inhibitorPD-1/PD-L1 inhibitor | Drug | Control group |
Primary outcome
Progression-free survival (PFS)
Time frame: through study completion, an average of 2 year.
Progression-free survival
the temperature
Time frame: through study completion, an average of 2 year.
Vital signs
blood pressure
Time frame: through study completion, an average of 2 year.
Vital signs
complete blood count
Time frame: through study completion, an average of 2 year.
laboratory index
adverse event and severe adverse event
Time frame: through study completion, an average of 2 year.
adverse event and severe adverse event, according to NCI-CTC V5.0
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: through study completion, an average of 2 year.
disease control rate (DCR)
Time frame: through study completion, an average of 2 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Ying Dong, Doctorate principal investigator
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
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 Centipeda minima+PD-1/PD-L1 inhibitor and PD-1/PD-L1 inhibitor in people with Lung Cancer, run by Second Affiliated Hospital, 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Apr 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Dong, Doctorate (13666669105, dongying74@zju.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: through study completion, an average of 2 year.). The study lists 5 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 17 Apr 2024.