Advanced or Metastatic NSCLCPhase 1NCT04942301
PK Study for Endostar Continuous Intravenous Infusion in NSCLC Patients With 1st-line Platinum Based Chemotherapy
A Phase 1 study testing Endostar, use the vein pump to pump drugs and combination therapy in people with Advanced or Metastatic NSCLC, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial is an open-label, randomized, multicenter study to explore Endostar in combination with standard platinum-based chemotherapy with different methods in patients with advanced/metastatic non-small cell lung cancer (NSCLC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic NSCLC
- What is being tested?
- Endostar, use the vein pump to pump drugs and combination therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 15 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in clinical trials and sign an informed consent form.
- Age ≥ 18 years old, including gender.
- Advanced or metastatic NSCLC confirmed by histology and/or cytology: Have not received Systemic chemotherapy for advanced disease (Patients with sensitive mutations such as EGFR and ALK have received corresponding standard alternative treatments, But patients who have not received chemotherapy can be included in the group; have received single-agent PD-L 1 and other immune checkpoint inhibitors Patients, but patients who have not received chemotherapy can enter the group).
- At least one measurable lesion (based on RECIST 1.1).
- ECOG scores 0~1.
- Expected survival time ≥ 3 months.
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- The functions of major organs are basically normal, and the laboratory test values during the screening period meet the following standards:
- System Laboratory Inspection Standard hematology Absolute neutrophil count >1.5 ×109/L Platelet >100×109/L Hemoglobin >90g/L kidney Serum creatinine or Creatinine clearance rate (CrCl) or glomerular filtration rate (GFR) (Cockcroft-Gault formula) <1.5 × ULN or >60 mL/min1.73m2 (for patients with creatinine level ≥ 1.5 × ULN) liver Total bilirubin (serum) <2.5 × ULN or Direct bilirubin <ULN (for patients with total bilirubin level ≥ 1.5×ULN) AST and ALT <2.5 × ULN or ≤5 × ULN (for patients with liver metastases) Blood clotting International normalized ratio (INR) or prothrombin time (PT) <1.5 × ULN, unless the patient is receiving anticoagulation therapy
- Urine routine Urine protein ≤+ (For patients with urine protein ≥++, 24-hour urine protein quantification is required, and 24-hour urine protein needs to be less than 1g)
- Women of childbearing age during the screening period had negative blood pregnancy test results. The patient agrees to self-sign and know Consent to use reliable contraceptive methods within 90 days after the end of treatment.
Who cannot join
- Patients with uncontrolled primary central nervous system tumors, brain metastases, or meningeal metastases. Patients who were asymptomatic or had their symptoms under treatment (stable and asymptomatic at least 4 weeks after treatment) were allowed to join the group.
- Imaging (CT, PET-CT, or MRI) shows tumors invading large blood vessels.
- It is first clear that pulmonary hemorrhage/hemoptysis (> 1/2 teaspoon about 2.5ml bright red blood) or other clinically significant bleeding symptoms or obvious bleeding possibility occurred in the first 3 months.
- Severe uncontrollable hypertension (defined as systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mg, or accompanied by hypertensive crisis, hypertensive encephalopathy).
- The QTcF interval of ECG> 480ms within 6 months before the first first time.
- Severe infections within 4 weeks before the first administration require intravenous antibiotics or hospitalization.
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- Before the first dose, the adverse events caused by any intervention have not recovered to normal or ≤1 grade. Patients with alopecia (any grade) and sensory neuropathy (≤2 grade) at both ends can be included in the group.
- Received other major surgery besides diagnosis or biopsy within 4 weeks before the first definition.
- 4 weeks or 5 half-lives before the first time (for investigational drugs with known half-lives) internally as a patient Received experimental drug treatment.
- Previously received anti-angiogenic drug treatment.
- Received systemic anti-tumor therapy within 4 weeks before the first dose, including chemotherapy, macromolecular targeting, immunotherapy, and endocrine therapy; within 2 weeks before the first dose or within 5 half-lives of the drug (whichever is longer) ) Receiving small-molecule targeted drug therapy; receiving Chinese/herbal medicine with anti-tumor indications within 2 weeks before the first dose.
- Patients who have received adjuvant chemotherapy within 6 months before the first dose and the disease recurs within 6 months after the start of adjuvant therapy.
- Obvious gastrointestinal bleeding (such as esophageal or gastric varices) or a clear bleeding tendency occurred within 4 weeks before the first dose.
- Those who are allergic to any active or inactive ingredients of Endo or the combined chemotherapeutics.
- Known acute or active hepatitis B, or chronic hepatitis C, or syphilis infection, or human immunodeficiency virus (HIV) infection.
- Patients during pregnancy or lactation.
- Take CYP2C8 substrates (such as repaglinide, rosiglitazone), CYP2C8 inhibitors (such as gemfibrozil), CYP2C8 inducers (such as rifampicin) within 14 days before using the test drug in the first cycle, CYP3A4 substrates (such as midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, triazolam), CYP3A4 inhibitors (such as a Zanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin), CYP3A4 inducer (Such as rifampicin, carbamazepine);
- The researcher believes that the patient has any clinical or laboratory abnormalities or other reasons that are not suitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country.
wei he contact
China1 site
Lan Mu
Shanghai, Shanghai Municipality, 210000
mu lan, 18706717673, mulan@simcere.com
About this study
Official title: PhaseⅠStudy to Evaluate PK, Safety, and Preliminary Efficacy of Endostar Standard-dose Intravenous Infusion and Continuous (Pump) Infusion in Combination With 1st-line Platinum-based Doublet Chemotherapy in Patients With Advanced NSCLC
This trial is an open-label, randomized, multicenter study to explore Endostar in combination with standard platinum-based chemotherapy with different methods in patients with advanced/metastatic non-small cell lung cancer (NSCLC)
Read the detailed description
Patients in group A received a standard 21-day treatment cycle of platinum-containing two-drug chemotherapy and endurance treatment. Yep The first cycle of the degree of use is 7.5mg/m2/day intravenous infusion for 4 hours (referred to as the time window of 4h 20min From the 1st day to the 14th day (D1-14 Endo cycle 2-4 uses 105mg/m2/cycle From the first day, continuous intravenous pump injection for 72 hours (the set time window is 72h±2h.).
Patients in group B received a standard 21-day treatment cycle of platinum-containing two-drug chemotherapy and endurance treatment. Yep The first cycle of the degree of use is 7.5mg/m2/day intravenous infusion for 4 hours (referred to as the time window is 4h±20min From the 1st day to the 14th day (D1-14 Endo cycle 2-4 is used 105mg/m2/cycle From the first day, continuous intravenous pump injection for 168 hours (set time window is 168h±2h).
Endostar and chemotherapy drugs are used for 4 cycles. Research will Use RECIST 1.1 standard to evaluate in progress and after enrollment Efficacy assessment will be conducted every 6±1 weeks until the disease progresses, new anti-tumor therapy is started, and the study is withdrawn or At the end of the study, the serum of Endo will be collected in different expected ways to evaluate the pharmacokinetic characteristics; Adverse events were evaluated according to CTCAE5.0 standards. The start time of the test is The first fine was when the informed consent form was signed. The end of the test is the last The subject completed 24 weeks after the first treatment.
- Conditions
- Advanced or Metastatic NSCLC
- Being tested
- Endostar, use the vein pump to pump drugs, combination therapy
- 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.
EndostarDrug
Also called recombinant human endostatin injection
This product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed
use the vein pump to pump drugsDevice
Also called vein pump
During the first 14 days of the first cycle, the experimental drug was pumped daily with an intravenous pump. During cycles 2-4, subjects in group A were pumped with experimental drugs for 3 days and subjects in group B were pumped with experimental drugs for 7 days.
combination therapyCombination product
Combination therapy with chemotherapy drugs was used
| Study group | Role | What they receive |
|---|---|---|
| Endostar pump for three days | Experimental | Group A: The first cycle, Endostar 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump for 72 hours; Receives: Drug: Endostar; Device: use the vein pump to pump drugs; Combination Product: combination therapy |
| Endostar pump for seven days | Experimental | Group B: Cycle 1, Endo 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump injection for 168 hours; Receives: Drug: Endostar; Device: use the vein pump to pump drugs; Combination Product: combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak time (Tmax)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
peak concentration (Cmax)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
area under curve (AUC, Including AUC0-t, AUC0-∞)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
terminal elimination half-life (T1/2)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
steady-state minimum blood concentration (CSS min)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
mean steady-state blood concentration (CSS AV)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
accumulation coefficient (RAC)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
mean residence time (MRT)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
apparent volume of distribution (VD)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
clearance rate (CL)
pharmacokinetic parameters
Measured: At the end of the second cycle, each cycle is 21 days
Secondary outcomes (1)
Adverse events (AE) incidence
Adverse event (AE) incidence
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start30 Jul 2021 (estimated)
- Primary completion25 Dec 2021 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiaojian zhang, Principal investigator, the director of the IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942301
- Sponsor's protocol ID
- SIM-1904-04-ENDO-101
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseⅠStudy to Evaluate PK, Safety, and Preliminary Efficacy of Endostar Standard-dose Intravenous Infusion and Continuous (Pump) Infusion in Combination With 1st-line Platinum-based Doublet Chemotherapy in Patients With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT04942301
- Acronym / sponsor ID
- SIM-1904-04-ENDO-101
- Conditions
- Advanced or Metastatic NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 25 Dec 2021 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 28 Jun 2021 (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 trial is an open-label, randomized, multicenter study to explore Endostar in combination with standard platinum-based chemotherapy with different methods in patients with advanced/metastatic non-small cell lung cancer (NSCLC)
Detailed description
Patients in group A received a standard 21-day treatment cycle of platinum-containing two-drug chemotherapy and endurance treatment. Yep The first cycle of the degree of use is 7.5mg/m2/day intravenous infusion for 4 hours (referred to as the time window of 4h 20min From the 1st day to the 14th day (D1-14 Endo cycle 2-4 uses 105mg/m2/cycle From the first day, continuous intravenous pump injection for 72 hours (the set time window is 72h±2h.).
Patients in group B received a standard 21-day treatment cycle of platinum-containing two-drug chemotherapy and endurance treatment. Yep The first cycle of the degree of use is 7.5mg/m2/day intravenous infusion for 4 hours (referred to as the time window is 4h±20min From the 1st day to the 14th day (D1-14 Endo cycle 2-4 is used 105mg/m2/cycle From the first day, continuous intravenous pump injection for 168 hours (set time window is 168h±2h).
Endostar and chemotherapy drugs are used for 4 cycles. Research will Use RECIST 1.1 standard to evaluate in progress and after enrollment Efficacy assessment will be conducted every 6±1 weeks until the disease progresses, new anti-tumor therapy is started, and the study is withdrawn or At the end of the study, the serum of Endo will be collected in different expected ways to evaluate the pharmacokinetic characteristics; Adverse events were evaluated according to CTCAE5.0 standards. The start time of the test is The first fine was when the informed consent form was signed. The end of the test is the last The subject completed 24 weeks after the first treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endostar pump for three days | Experimental | Drug: Endostar, Device: use the vein pump to pump drugs, Combination Product: combination therapyGroup A: The first cycle, Endostar 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump for 72 hours; |
| Endostar pump for seven days | Experimental | Drug: Endostar, Device: use the vein pump to pump drugs, Combination Product: combination therapyGroup B: Cycle 1, Endo 7.5mg/m2/day, intravenous infusion for 4 hours, D1-14 First 2-4 cycles, Endo 105mg/m2/cycle D1 starts intravenous pump injection for 168 hours; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteer to participate in clinical trials and sign an informed consent form.
- Age ≥ 18 years old, including gender.
- Advanced or metastatic NSCLC confirmed by histology and/or cytology: Have not received Systemic chemotherapy for advanced disease (Patients with sensitive mutations such as EGFR and ALK have received corresponding standard alternative treatments, But patients who have not received chemotherapy can be included in the group; have received single-agent PD-L 1 and other immune checkpoint inhibitors Patients, but patients who have not received chemotherapy can enter the group).
- At least one measurable lesion (based on RECIST 1.1).
- ECOG scores 0~1.
Key exclusion criteria (18 listed)
- Patients with uncontrolled primary central nervous system tumors, brain metastases, or meningeal metastases. Patients who were asymptomatic or had their symptoms under treatment (stable and asymptomatic at least 4 weeks after treatment) were allowed to join the group.
- Imaging (CT, PET-CT, or MRI) shows tumors invading large blood vessels.
- It is first clear that pulmonary hemorrhage/hemoptysis (> 1/2 teaspoon about 2.5ml bright red blood) or other clinically significant bleeding symptoms or obvious bleeding possibility occurred in the first 3 months.
- Severe uncontrollable hypertension (defined as systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mg, or accompanied by hypertensive crisis, hypertensive encephalopathy).
- The QTcF interval of ECG> 480ms within 6 months before the first first time.
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 |
|---|---|---|
| EndostarAlso: recombinant human endostatin injectionThis product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed | Drug | Endostar pump for seven days, Endostar pump for three days |
| use the vein pump to pump drugsAlso: vein pumpDuring the first 14 days of the first cycle, the experimental drug was pumped daily with an intravenous pump. During cycles 2-4, subjects in group A were pumped with experimental drugs for 3 days and subjects in group B were pumped with experimental drugs for 7 days. | Device | Endostar pump for seven days, Endostar pump for three days |
| combination therapyCombination therapy with chemotherapy drugs was used | Combination product | Endostar pump for seven days, Endostar pump for three days |
Primary outcome
peak time (Tmax)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
peak concentration (Cmax)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
area under curve (AUC, Including AUC0-t, AUC0-∞)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
terminal elimination half-life (T1/2)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
steady-state minimum blood concentration (CSS min)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
mean steady-state blood concentration (CSS AV)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
accumulation coefficient (RAC)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
mean residence time (MRT)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
apparent volume of distribution (VD)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
clearance rate (CL)
Time frame: At the end of the second cycle, each cycle is 21 days
pharmacokinetic parameters
1 secondary outcome
Adverse events (AE) incidence
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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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.
wei he contact
xiaojian zhang principal investigator
the director of the IRB
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 Endostar, use the vein pump to pump drugs and combination therapy in people with Advanced or Metastatic NSCLC, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 10 inclusion and 18 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 30 Jun 2021. 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 qingxia fan (13939039058, fqx2243@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak time (Tmax) (time frame: At the end of the second cycle, each cycle is 21 days). The study lists 10 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 30 Jun 2021.