Non-Small-Cell Lung CancerPhase 2NCT03728374
Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma
A Phase 2 study testing Anlotinib in people with Non-Small-Cell Lung Cancer, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Nov 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up;
- 2. Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology; diagnosed as stage IIIB, IIIC or IV according to the 2017 new version of the UICC lung cancer staging criteria (8th edition); : Patients with stage IIIB and IIIC must be at least one measurable lesion in patients who cannot be surgically resected according to RECIST 1.1;
- 3. For local advanced or metastatic NSCLC, disease progression occurred after first-line systemic treatment previously;
- 4. Provide detectable specimens (tissue or cancerous pleural effusion) for genotyping before enrollment, and the patients should be with negative EGFR, ALK, and ROS1 gene test results;
- 5. The patient refuses to receive second-line chemotherapy (such as docetaxel, pemetrexed, etc.); or is assessed to be unable to tolerate second-line chemotherapy;
- 6. Age ≥ 65 years old, ECOG PS 0-2 points;
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- 7. At least one target lesion that has not received radiotherapy in the past 3 months, and accurate measurement by magnetic resonance imaging (MRI) or computed tomography (CT) in at least 1 direction (maximum diameter required to be recorded) (conventional CT ≥ 20 mm or ≥ 10 mm under spiral CT);
- 8. Life expectancy is at least 3 months;
- 9. The damage subjects received from other treatments has recovered(NCI-CTCAE version 4.0 grade ≤ 1), the interval of subjects receiving nitrosourea or mitomycin should be at least 6 weeks; the interval subjects receiving other cytotoxic drugs, bevacate Avastin (Avastin), surgery should be at least 4 weeks; the interval subjects receiving radiotherapy (except for local palliative radiotherapy) should be at least 2 weeks;
- 10. The main organs function are normally, the following criteria are met: (1) Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB≥90 g/L; ANC ≥ 1.5×10^9/L; PLT ≥80×10^9/L; (2) Biochemical examinations must meet the following criteria: TBIL<1.5×ULN; ALT and AST < 2.5×ULN, and for patients with liver metastases < 5×ULN; Serum Cr ≤ 1.25×ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Gault formula).
Who cannot join
- 1. Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- 2. Lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (>50 ml / day);
- 3. Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
- 4. Elderly patients who have been evaluated to be able to tolerate second-line chemotherapy
- 5. Allergic reactions to allosterinib or excipients in the test drug;
- 6. A patient who develops an allergic reaction to contrast agent;
- 7. History and comorbidities
- 1) Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 28 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms); 2) The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks; 3) Other active malignancies that require simultaneous treatment; 4) Patients with a history of malignant tumors except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone a curative treatment and have no disease recurrence within 5 years from the start of treatment 5) Patients with previous anti-tumor treatment-related adverse reactions (excluding hair loss) who have not recovered to NCI-CTCAE ≤1; 6) Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 7) Note: Under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, low-dose heparin (adult daily dose of 0.6 million to 12,000 U) or low-dose aspirin (daily dosage ≤ 100 mg) is allowed for preventive purposes; 8) Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g; 9) Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal medical treatment); 10) The effects of surgery or trauma have been eliminated for less than 14 days before enrollment in subjects who have undergone major surgery or have severe trauma; 11) Severe acute or chronic infections requiring systemic treatment; 12) Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%; 13) There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma; 14) Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment; 15) Long-term unhealed wounds or fractures; 16) Severe weight loss (greater than 10%) within 6 weeks prior to randomization; 17) Decompensated diabetes or other ailments treated with high doses of glucocorticoids; 18) Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 19) Clinically significant hemoptysis (daily hemoptysis greater than 50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis; 20) Events of venous/venous thrombosis occurring within the first 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 21) Planned for systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (4 weeks prior to enrollment in other anti-cancer drug clinical trials or within 4 weeks prior to grouping or during the study period Or use mitomycin C) within 6 weeks prior to receiving the test drug. Radiation-rehabilitation radiotherapy (EF-RT) was performed within 4 weeks before grouping or limited-field radiotherapy to be evaluated for tumor lesions within 2 weeks before grouping.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma Who Refused Chemotherapy: an Open, Single-arm, Single-center Clinical Trial
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib(12mg,po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Subgroup analysis results suggest that elderly patients may get longer mPFS and mOS.
Therefore, the investigators envisage an open, single-arm, single-center clinical trial using anlotinib in elderly patients with EGFR wild-type lung adenocarcinoma who refused chemotherapy, to find if anlotinib is a better option in NSCLC second-line therapy.
Read the detailed description
It is an open, single-arm, single-center clinical trial conducted in China, and plan to Recruiting 38 patients (≥65 years old, ECOG PS 0-2) who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Anlotinib
- 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.
AnlotinibDrug
Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle)
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib | Experimental | Not described Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progress free survival
Measured: each 42 days up to PD or death(up to 24 months)
Secondary outcomes (5)
OS
Overall Survival
Measured: From randomization until death (up to 24 months)
ORR
Objective Response Rate
Measured: Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
DCR
Disease Control Rate
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
QoL: EORTC QLQ-C30
use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Record Adverse Events (AEs) according to CTCAE (V4.03). To find Potential adverse reaction, measure blood pressure at least 2 times a week and test blood routine, Blood biochemical, Urine routine, stool routine, coagulation function, electrocardiogram for each follow-up, record and analyze the number of abnormal data.
Measured: Until 21 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2020 (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 First Affiliated Hospital of Wenzhou Medical 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
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanyan Xu, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Yuping Li, doctor, Study chair, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728374
- Sponsor's protocol ID
- FirstWenzhouMU
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- 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 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Hydrochloride as Second-line Therapy in Elderly Patients With EGFR Wild-type Lung Adenocarcinoma Who Refused Chemotherapy: an Open, Single-arm, Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT03728374
- Acronym / sponsor ID
- FirstWenzhouMU
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 2 Nov 2018 (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.
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib(12mg,po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Subgroup analysis results suggest that elderly patients may get longer mPFS and mOS.
Therefore, the investigators envisage an open, single-arm, single-center clinical trial using anlotinib in elderly patients with EGFR wild-type lung adenocarcinoma who refused chemotherapy, to find if anlotinib is a better option in NSCLC second-line therapy.
Detailed description
It is an open, single-arm, single-center clinical trial conducted in China, and plan to Recruiting 38 patients (≥65 years old, ECOG PS 0-2) who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib | Experimental | Drug: Anlotinib |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 1. Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up;
- 2. Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology; diagnosed as stage IIIB, IIIC or IV according to the 2017 new version of the UICC lung cancer staging criteria (8th edition); : Patients with stage IIIB and IIIC must be at least one measurable lesion in patients who cannot be surgically resected according to RECIST 1.1;
- 3. For local advanced or metastatic NSCLC, disease progression occurred after first-line systemic treatment previously;
- 4. Provide detectable specimens (tissue or cancerous pleural effusion) for genotyping before enrollment, and the patients should be with negative EGFR, ALK, and ROS1 gene test results;
- 5. The patient refuses to receive second-line chemotherapy (such as docetaxel, pemetrexed, etc.); or is assessed to be unable to tolerate second-line chemotherapy;
Key exclusion criteria (8 listed)
- 1. Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- 2. Lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (>50 ml / day);
- 3. Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
- 4. Elderly patients who have been evaluated to be able to tolerate second-line chemotherapy
- 5. Allergic reactions to allosterinib or excipients in the test drug;
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 |
|---|---|---|
| AnlotinibAnlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle) | Drug | Anlotinib |
Primary outcome
PFS
Time frame: each 42 days up to PD or death(up to 24 months)
Progress free survival
5 secondary outcomes
OS
Time frame: From randomization until death (up to 24 months)
ORR
Time frame: Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
DCR
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
QoL: EORTC QLQ-C30
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Until 21 day safety follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- 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.
Yuping Li, doctor study chair
First Affiliated Hospital of Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib in people with Non-Small-Cell Lung Cancer, run by First Affiliated Hospital of Wenzhou Medical University.
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 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: status not confirmed, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Yuping Li, doctor (86 13587600968, wzliyp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: each 42 days up to PD or death(up to 24 months)). 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 Nov 2018.