Non-small Cell Lung CancerPhase 2NCT06341530
Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer
A Phase 2 study testing anlotinib combined with penpulimab in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- anlotinib combined with penpulimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Dec 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old (calculated on the date of signing the informed consent);
- ECOG PS: 0-1;
- Expected survival ≥3 months;
- histopathologically confirmed non-small cell lung cancer with at least one measurable lesion (according to RECIST 1.1);
- Patients who provided detectable specimens (tissue or cancerous pleural fluid) for genotype testing before enrollment, and whose EGFR and ALK gene test results were negative; Or patients with negative test results; Or patients with positive test results and who are resistant or intolerant after receiving relevant targeted drug therapy.
- Have not been treated with a systematic regimen;
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- Patients voluntarily join the project and sign informed consent;
- The function of vital organs is normal
- Physicians can benefit from anrotinib hydrochloride combined immunotherapy based on current clinical practice assessment;
- Patients voluntarily join the project and sign informed consent;
- Require initiation of antirotinib hydrochloride combined immunotherapy within 28 days of informed consent;
Who cannot join
- Known allergy or metabolic disorder to any drug in the treatment regimen;
- Those who refuse to take reliable contraceptive methods during pregnancy and lactation or in the appropriate age period;
- Have any history of uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction, blood, endocrine system diseases, and other malignant tumors);
- Have a history of psychotropic substance abuse, alcoholism or drug use;
- Currently or about to participate in other anti-tumor drug clinical trials;
- Have active, known, or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, pituitaritis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment, etc.). Patients with hypothyroidism who only need hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) may be included;
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- During the 6 months prior to entering the study, the following conditions occurred: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, poorly controlled arrhythmias (including QTcF interphase >450 ms in men, > 470 ms in women, >450 ms in women, >450 ms in men, > 470 ms in women, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism);
- Patients receiving hematopoietic stem cells or organ transplants;
- Other factors that may affect patient safety or compliance as determined by the investigator. Such as a serious illness (including mental illness) requiring co-treatment, serious laboratory abnormalities, or other family or social factors. Severe hepatic and renal insufficiency as judged by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhe Cheng
Zhengzhou, Henan, 450000
Zhe Cheng, 18638027777, cz711010@163.com
About this study
Official title: Prospective Clinical Study of Anlotinib Hydrochloride Capsule Combined With Penpulimab Injection in the Front-line Treatment of Advanced Non-small Cell Lung Cancer Patients
In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects.
This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer.
Read the detailed description
This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. To describe the therapeutic mode of anlotinib hydrochloride combined with penpulimab injection in the treatment of patients with non-small cell lung cancer (including treatment regimen, dosage, number of treatment cycles, dose adjustment/discontinuation and reasons) and treatment outcomes.Primary endpoints: Progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR). Secondary endpoints: Overall survival (OS), quality of life score (QoL). Safety evaluation indicators: vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- anlotinib combined with penpulimab
- 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.
anlotinib combined with penpulimabDrug
Also called Anti-angiogenesis combined with immunotherapy
single arm
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Anlotinib combined with penpulimab Receives: Drug: anlotinib combined with penpulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
From initiation of the investigational drug to first recording of disease progression (PD) Or the time between the date of death, depending on which occurs first. If no disease progression is observed, the cut-off date should be the date of the last tumor measurement
Measured: Quaque 3 week±7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start31 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengzhe, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341530
- Sponsor's protocol ID
- SURPASS-1
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Anlotinib Hydrochloride Capsule Combined With Penpulimab Injection in the Front-line Treatment of Advanced Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06341530
- Acronym / sponsor ID
- SURPASS-1
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2024 (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.
In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects.
This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer.
Detailed description
This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. To describe the therapeutic mode of anlotinib hydrochloride combined with penpulimab injection in the treatment of patients with non-small cell lung cancer (including treatment regimen, dosage, number of treatment cycles, dose adjustment/discontinuation and reasons) and treatment outcomes.Primary endpoints: Progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR). Secondary endpoints: Overall survival (OS), quality of life score (QoL). Safety evaluation indicators: vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: anlotinib combined with penpulimabAnlotinib combined with penpulimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old (calculated on the date of signing the informed consent);
- ECOG PS: 0-1;
- Expected survival ≥3 months;
- histopathologically confirmed non-small cell lung cancer with at least one measurable lesion (according to RECIST 1.1);
- Patients who provided detectable specimens (tissue or cancerous pleural fluid) for genotype testing before enrollment, and whose EGFR and ALK gene test results were negative; Or patients with negative test results; Or patients with positive test results and who are resistant or intolerant after receiving relevant targeted drug therapy.
Key exclusion criteria (9 listed)
- Known allergy or metabolic disorder to any drug in the treatment regimen;
- Those who refuse to take reliable contraceptive methods during pregnancy and lactation or in the appropriate age period;
- Have any history of uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction, blood, endocrine system diseases, and other malignant tumors);
- Have a history of psychotropic substance abuse, alcoholism or drug use;
- Currently or about to participate in other anti-tumor drug clinical trials;
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 |
|---|---|---|
| anlotinib combined with penpulimabAlso: Anti-angiogenesis combined with immunotherapysingle arm | Drug | Treatment group |
Primary outcome
Progression-free survival
Time frame: Quaque 3 week±7 Days
From initiation of the investigational drug to first recording of disease progression (PD) Or the time between the date of death, depending on which occurs first. If no disease progression is observed, the cut-off date should be the date of the last tumor measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anlotinib combined with penpulimab in people with Non-small Cell Lung Cancer, 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 11 inclusion and 9 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 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhe Cheng (18638027777, cz711010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Quaque 3 week±7 Days). 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 2 Apr 2024.