Lung CancerAPNCT05319886
Observational Study of the Efficacy and Safety of Anlotinib Combined With Penpulimab in Elderly Lung Cancer Patients
An observational study of Lung Cancer and Lung Carcinoma, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
This prospective observational study will evaluate the efficacy and safety of anlotinib in combination with Penpulimab in elderly patients with lung cancer. Data will be collected from each patient at baseline and after 4-6 cycles of therapy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Cancer, Lung Carcinoma, Non Small Cell Lung Cancer
- What is being tested?
- Anlotinib and Penpulimab
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2022to 30 Mar 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 65 years and older
- All sexes
- Older adult
Study population: At least 65 years old with locally advanced, recurrent or metastatic stage IIIB-IV non-small cell lung cancer.
Who may be able to join
- At least 65 years old;
- Non-small cell lung cancer with locally advanced, recurrent or metastasis, which confirmed by histologically or cytologically (except sputum cytology) and evaluated as IIIB-IV stage, who are unresectable or unable to undergo radical radiotherapy or refuse radical radiotherapy. (If multiple tumor components are mixed, it should be classified according to their predominant cell type);
- Participants are required to have one measurable disease per RECIST 1.1;
- Unsuitable or unwilling to receive radical treatment methods (such as radical chemoradiotherapy and/or surgery) and have not received prior systemic therapy;
- ECOG performance status of 0 to 2; The expected survival is more than 3 months;
- Adequate organ and marrow function defined as follows:
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- Hemoglobin (HB) ≥90 g/L (no blood transfusion within 28 days);
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelet count (PLT) ≥ 100×109/L;
- Aspartate Transaminase (AST) ≤ 1.5 x upper limit of normal (ULN);
- Alaninetransaminase (ALT) ≤ 1.5 x ULN (ALT and AST ≤ 5 x ULN if liver metastases are present);
- Alkaline phosphatase (ALP) ≤ 1.5 x ULN;
- Albumin (ALB) ≥ 30g/L;
- Creatinine ≤1.5 x ULN or Creatinine Clearance (CCr) ≥ 60 ml/min;
- International normalized ratio (INR) ≤ 1.5 x ULN;
- Partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Prothrombin time (PT) ≤ 1.5 x ULN ;
- Thyrotropic hormone (TSH) ≤ ULN (When TSH value is abnormal, T3 and T4 levels is normal, which can be enrolled);
- Urine protein < (++), or 24-hour urine protein amount < 1.0 g ;
- Patients must have adequate cardiac function, defined as:
- Left ventricular ejection fraction (LVEF) > 50% as determined by cardiac echocardiogram.
- -Patients enrolled in this study voluntarily and signed an informed consent with a good compliance.
Who cannot join
- Participants who have active infection;
- Patients with known immunodeficiency diseases (e.g. psoriasis, active arthritis, immune nephropathy, HIV, etc);
- Participants with no measurable disease;
- Patients with cancerous meningitis and spinal cord compression;
- Participants with active central nervous system (CNS) metastases (clinically stable and maintained for at least 2 weeks after adequate treatment of CNS metastases and do not require treatment such as glucocorticoids and dehydrating drugs are eligible for enrollment);
- Previously treated with chemotherapy drugs (except neoadjuvant therapy) / targeted drugs / immunotherapy;
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- Participants who were confirmed severe abnormalities of gastrointestinal function (e.g. inability to take oral medications, uncontrollable nausea or vomiting, history of major gastrointestinal resection, untreated recurrent diarrhea, untreated gastric disease requiring long-term acid-suppressing PPI-like medications, Crohn's disease, ulcerative colitis);
- Patients with central squamous lung cancer on imaging;
- Patients who had an arterial/venous thrombotic event within 6 months, such as cerebrovascular accident (temporary ischemic attack is excluded), deep vein thrombosis and pulmonary embolism;
- Patients whose imaging shows that the tumor has invaded a significant vessel or have a high risk of fatal hemorrhage due to tumor invasion of a significant vessel during the follow-up study judged by the investigator; or who have bleeding tendencies (e.g., active peptic ulcer) or receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogs;
- Patients who had antineoplastic therapy against other malignancies, including radiotherapy, chemotherapy, immunotherapy and herbal medicine (except previously eradicated malignancies without recurrent metastases for ≥ 5 years);
- Patients with uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage (except patients who do not require drainage of effusion or whose effusion does not increase significantly after 3 days of cessation of drainage);
- Patients who have used immunosuppressive drugs within 4 weeks prior to the study treatment, except for topical glucocorticoids by nasal spray, inhalation or other routes or physiologic doses of systemic glucocorticoids (no more than 10 mg/day of prednisone or equivalent doses of other glucocorticoids);
- Patients who have known or suspected active autoimmune disease (congenital or acquired), such as interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be enrolled; Patients with type I diabetes with good insulin control may be enrolled);
- Patients who have known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Anticipants who have hypersensitivity to any component of anlotinib and monoclonal antibodies;
- Anticipants who have active interstitial lung disease requiring treatment;
- Anticipants who have a history of psychotropic substance abuse and are unable to abstain or have a psychiatric disorder;
- Anticipants who have participated in another anti-tumor clinical trial within four weeks;
- Anticipants who administered anti-infective vaccines (e.g., influenza virus vaccine, human papillomavirus vaccine) within 4 weeks prior to study therapy; During the treatment period, in addition to inactive vaccines, other vaccines are prohibited;
- Anticipants who have undergone major surgery (except for diagnostic purposes) within 4 weeks (28 days) prior to the administration of the study;
- Patients who are not suitable for enrollment in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453100
Yinghua Ji, Master, 13663030446, 54234317@qq.com
Yana Zhang, Doctor, 15093230340, Drzhangyana@hotmail.com
About this study
Official title: A Phase IV Observational Study Evaluating the Efficacy and Safety of Anlotinib in Combination With Penpulimab as First-line Treatment in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
This prospective observational study will evaluate the efficacy and safety of anlotinib in combination with Penpulimab in elderly patients with lung cancer. Data will be collected from each patient at baseline and after 4-6 cycles of therapy.
Read the detailed description
This research study is a Phase IV clinical trial. Participants are being involved in the portion of the study to observe the efficacy and safety of an observational intervention and also tries to evaluate the disease control rate (such as Progression-Free-Survival, overall survival, Objective Response Rate, Disease control rates, Duration of Response, Quality of Life and Adverse events).
Anlotinib is a small molecule multi-target tyrosine kinase inhibitor, can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesis and tumor growth inhibiting effects. Penpulimab injection is a new PD-1 monoclonal antibody drug, was approved for marketing by the State Drug Administration (NMPA) of China for the indication: treatment of adult patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) who have undergone at least second-line systemic chemotherapy. By putting these two drugs together, the investigators hope that it will have a greater effect on cancer growth in elderly patients with lung cancer.
Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (complete response (CR)+partial response (PR)+stable disease (SD)) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as disease progression (PD). Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD.
The purpose of this study is to:
- Test the efficacy of these two drugs Anlotinib and Penpulimab in elderly lung cancer;
- Determine the Progression-Free-Survival of the combination;
- Further evaluate the side effect profile for the combination of Anlotinib and Penpulimab in elderly lung cancer patients.
- Conditions
- Lung Cancer, Lung Carcinoma, Non Small Cell Lung Cancer, Non-small Cell Carcinoma, Lung Neoplasm
- Being tested
- Anlotinib and Penpulimab
- Keywords
- Anlotinib, Penpulimab
- Medical subject headings
- Lung Neoplasms, 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 and PenpulimabDrug
Also called AL3818 and AK105
Anlotinib 12mg, po, qd, with 2 weeks off for 1 week. Penpulimab 200mg, ivgtt, q3w. Efficacy was evaluated every 2 cycles. Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (CR+PR+SD) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as PD. Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib and Penpulimab | Not described Receives: Drug: Anlotinib and Penpulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The time from the start of treatment until objective tumor progression or death. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time.
Measured: 2 years
Secondary outcomes (5)
Overall Survival
Overall survival is the time elapsed between enrollment and death of any cause. For participants who don't die until the end of treatment, the overall survival data will be analyzed retrospectively based on their date of death after the end of study.
Measured: 2 years
Objective Response Rate
This refers to the percentage of patients with a certain amount of tumor shrinkage that is maintained for a certain period of time, including CR and PR.
Measured: 2 years
Disease control rates
Includes the number of cases of CR, PR, and SD with confirmed disease as a percentage of patients evaluable for efficacy.
Measured: 2 years
Duration of Response
Time between the start of the first evaluation of the tumor as CR or PR and the first evaluation of PD or death from any cause
Measured: 2 years
Adverse events
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start16 May 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 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.
- 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
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319886
- Sponsor's protocol ID
- LC202103001
- Acronym
- AP
- Status last verified
- May 2022
- First submitted
- 1 Apr 2022
- Last updated
- 20 May 2022
- 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Observational Study Evaluating the Efficacy and Safety of Anlotinib in Combination With Penpulimab as First-line Treatment in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05319886
- Acronym / sponsor ID
- AP / LC202103001
- Conditions
- Lung Cancer, Lung Carcinoma, Non Small Cell Lung Cancer, Non-small Cell Carcinoma, Lung Neoplasm
- Keywords
- Anlotinib, Penpulimab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 8 Apr 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 will evaluate the efficacy and safety of anlotinib in combination with Penpulimab in elderly patients with lung cancer. Data will be collected from each patient at baseline and after 4-6 cycles of therapy.
Detailed description
This research study is a Phase IV clinical trial. Participants are being involved in the portion of the study to observe the efficacy and safety of an observational intervention and also tries to evaluate the disease control rate (such as Progression-Free-Survival, overall survival, Objective Response Rate, Disease control rates, Duration of Response, Quality of Life and Adverse events).
Anlotinib is a small molecule multi-target tyrosine kinase inhibitor, can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesis and tumor growth inhibiting effects. Penpulimab injection is a new PD-1 monoclonal antibody drug, was approved for marketing by the State Drug Administration (NMPA) of China for the indication: treatment of adult patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) who have undergone at least second-line systemic chemotherapy. By putting these two drugs together, the investigators hope that it will have a greater effect on cancer growth in elderly patients with lung cancer.
Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (complete response (CR)+partial response (PR)+stable disease (SD)) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as disease progression (PD). Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD.
The purpose of this study is to:
- Test the efficacy of these two drugs Anlotinib and Penpulimab in elderly lung cancer;
- Determine the Progression-Free-Survival of the combination;
- Further evaluate the side effect profile for the combination of Anlotinib and Penpulimab in elderly lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib and Penpulimab | – | Drug: Anlotinib and Penpulimab |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- At least 65 years old with locally advanced, recurrent or metastatic stage IIIB-IV non-small cell lung cancer.
Key inclusion criteria (22 listed)
- At least 65 years old;
- Non-small cell lung cancer with locally advanced, recurrent or metastasis, which confirmed by histologically or cytologically (except sputum cytology) and evaluated as IIIB-IV stage, who are unresectable or unable to undergo radical radiotherapy or refuse radical radiotherapy. (If multiple tumor components are mixed, it should be classified according to their predominant cell type);
- Participants are required to have one measurable disease per RECIST 1.1;
- Unsuitable or unwilling to receive radical treatment methods (such as radical chemoradiotherapy and/or surgery) and have not received prior systemic therapy;
- ECOG performance status of 0 to 2; The expected survival is more than 3 months;
Key exclusion criteria (22 listed)
- Participants who have active infection;
- Patients with known immunodeficiency diseases (e.g. psoriasis, active arthritis, immune nephropathy, HIV, etc);
- Participants with no measurable disease;
- Patients with cancerous meningitis and spinal cord compression;
- Participants with active central nervous system (CNS) metastases (clinically stable and maintained for at least 2 weeks after adequate treatment of CNS metastases and do not require treatment such as glucocorticoids and dehydrating drugs are eligible for enrollment);
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 and PenpulimabAlso: AL3818 and AK105Anlotinib 12mg, po, qd, with 2 weeks off for 1 week. Penpulimab 200mg, ivgtt, q3w. Efficacy was evaluated every 2 cycles. Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (CR+PR+SD) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as PD. Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD. | Drug | Anlotinib and Penpulimab |
Primary outcome
Progression Free Survival
Time frame: 2 years
The time from the start of treatment until objective tumor progression or death. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time.
5 secondary outcomes
Overall Survival
Time frame: 2 years
Objective Response Rate
Time frame: 2 years
Disease control rates
Time frame: 2 years
Duration of Response
Time frame: 2 years
Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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.
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 and Lung Carcinoma, run by The First Affiliated Hospital of Xinxiang Medical College 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 22 inclusion and 22 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 20 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinghua Ji, Master (13663030446, 54234317@qq.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: 2 years). 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 20 May 2022.