Non-small Cell Lung CancerPhase 2ALTER-L024NCT03732001
A Study of Anlotinib in Combination With Docetaxel Versus Docetaxel Alone in Participants With Advanced NSCLC
A Phase 2 study testing Anlotinib combined Docetaxel and Docetaxel in people with Non-small Cell Lung Cancer, run by China Medical University, China at 1 site in China.
Trial summary
Evaluate the efficacy and safety of Anlotinib in combination with Docetaxel versus Docetaxel in patients with advanced non-small lung cancer after failure of first-line Chemotherapy . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Anlotinib combined Docetaxel and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2018to 9 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Diagnosed as 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);Note:Patients with stage IIIB and IIIC must be at least one measurable lesion in patients who cannot be surgically resected;
- 2.Patients who negative in EGFR\&ALK can participate after systematic chemotherapy treatments or cannot suffer，and no Docetaxel before;Patients who positive in EGFR\&ALK, must have treatment with relative targeted drugs，then after systematic chemotherapy treatments or cannot suffer，and no Docetaxel before；
- 3. Age 18-75 years old, Female or Male；
- 4. PS 0-1 points（ECOG）;
- 5. Life expectancy is at least 3 months;
- 6. 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,target lesion maximum diameter required to be recorded ≥ 10 mm (lymphaden minimum diameter must ≥ 15 mm can be regard as target lesion );
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- 7.The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 72 hours before the research; The man patients who must agree to take contraceptive methods during the research and within another 3 months after it;
- 8.The main organs function are normally, the following criteria are met:
- Blood routine examination must meet the following criteria:
- ANC ≥ 1.5×10^9/L;PLT ≥90×10^9/L; HB≥90 g/L;
- 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 ≤ 1.5×ULN or endogenous creatinine clearance > 50 ml/min
- LVEF≥50%;
- QTcF<450ms(male),QTcF<470ms（female）;
- 9.Signed and dated informed consent;
Who cannot join
- 1.have used Anlotinib 、Docetaxel before；
- 2.Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- 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.History and comorbidities
- 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 14 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms);
- The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks;
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- Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
- 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;
- Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included;
- 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;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;
- Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
- 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;
- Severe acute or chronic infections requiring systemic treatment;
- 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%;
- There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma;
- Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment;
- Long-term unhealed wounds or fractures;
- Decompensated diabetes or other ailments treated with high doses of glucocorticoids;
- Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- 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;
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- 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.
- Allergies,or known to have a history of allergies to the drug components;
- History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- The woman patients of childbearing age with positive pregnancy test or unwilling to take effective contraceptive measures during the whole trial period;
- According to the judgment of the investigator, there are serious accompanying diseases that endanger the safety of the patient or affect the patient to complete the study;
- A clear history of neurological or psychiatric disorders, including epilepsy or dementia;
- Cirrhosis, decompensated liver disease, untreated active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 500 IU / mL; hepatitis C: HCV RNA positive and abnormal liver function); hepatitis B and hepatitis C co-infection;
- 5.The discretion of the investigator, the patient may have other factors that may cause the study to be terminated, such as other serious illnesses or serious laboratory abnormalities, or family or society factors;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu, Ph.D
About this study
Official title: A Multicenter,Exploratory Study of Anlotinib in Combination With Docetaxel Versus Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Evaluate the efficacy and safety of Anlotinib in combination with Docetaxel versus Docetaxel in patients with advanced non-small lung cancer after failure of first-line Chemotherapy .
Read the detailed description
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. Therefore, the investigators envisage using anlotinib plus docetaxel treat the advanced Non-small cell lung cancer patients who were failure of first-line Chemotherapy , to further improve the patient's PFS.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Anlotinib combined Docetaxel, Docetaxel
- 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 DocetaxelDrug
Anlotinib ( 12mg, QD, PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2, IV, d1, 21 days per cycle)
DocetaxelDrug
Docetaxel (75mg/m2, IV, d1, 21 days per cycle)
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib combined Docetaxel | Experimental | patients treated with Anlotinib and Docetaxel (21 days for 1 cycle) until disease progress or toxicity cannot be tolerated or patients withdraw consent Receives: Drug: Anlotinib combined Docetaxel |
| Docetaxel | Active comparator | patients treated with Docetaxel (21 days for 1 cycle) until disease progress or toxicity cannot be tolerated or patients withdraw consent Receives: Drug: Docetaxel |
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 (4)
OS
Overall Survival
Measured: From randomization until death (up to 24 months)
ORR
Objective Response Rate
Measured: 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)
Safety and Tolerability: Number of Participants with Adverse Events
Number of Participants with Adverse Events
Measured: Until 30 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 posted6 Nov 2018
- Study start8 Nov 2018
- Primary completion9 Nov 2019 (estimated)
- Study completion9 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital, The Second Affiliated Hospital of Dalian Medical University, General Hospital of Shenyang Military Region, The People's Hospital of Liaoning Province, Shenyang Chest Hospital, Anshan Tumor Hospital, Affiliated Zhongshan Hospital of Dalian University, The First People's Hospital of Jingzhou, Benxi Cental Hospital, Panjin Liaohe Oilfield Gem Flower Hospital, Panjin Central Hospital
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Yunpeng Liu, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732001
- Sponsor's protocol ID
- ALTER-L024
- Acronym
- ALTER-L024
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 28 Nov 2018
- 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 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Exploratory Study of Anlotinib in Combination With Docetaxel Versus Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT03732001
- Acronym / sponsor ID
- ALTER-L024 / ALTER-L024
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- Shengjing Hospital, The Second Affiliated Hospital of Dalian Medical University, General Hospital of Shenyang Military Region, The People's Hospital of Liaoning Province, Shenyang Chest Hospital, Anshan Tumor Hospital, Affiliated Zhongshan Hospital of Dalian University, The First People's Hospital of Jingzhou, Benxi Cental Hospital, Panjin Liaohe Oilfield Gem Flower Hospital, Panjin Central Hospital
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 9 Nov 2019 (estimated)
- Study completion
- 9 Nov 2020 (estimated)
- First posted
- 6 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.
Evaluate the efficacy and safety of Anlotinib in combination with Docetaxel versus Docetaxel in patients with advanced non-small lung cancer after failure of first-line Chemotherapy .
Detailed description
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. Therefore, the investigators envisage using anlotinib plus docetaxel treat the advanced Non-small cell lung cancer patients who were failure of first-line Chemotherapy , to further improve the patient's PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib combined Docetaxel | Experimental | Drug: Anlotinib combined Docetaxelpatients treated with Anlotinib and Docetaxel (21 days for 1 cycle) until disease progress or toxicity cannot be tolerated or patients withdraw consent |
| Docetaxel | Active comparator | Drug: Docetaxelpatients treated with Docetaxel (21 days for 1 cycle) until disease progress or toxicity cannot be tolerated or patients withdraw consent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1.Diagnosed as 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);Note:Patients with stage IIIB and IIIC must be at least one measurable lesion in patients who cannot be surgically resected;
- 2.Patients who negative in EGFR\&ALK can participate after systematic chemotherapy treatments or cannot suffer，and no Docetaxel before;Patients who positive in EGFR\&ALK, must have treatment with relative targeted drugs，then after systematic chemotherapy treatments or cannot suffer，and no Docetaxel before；
- 3. Age 18-75 years old, Female or Male；
- 4. PS 0-1 points（ECOG）;
- 5. Life expectancy is at least 3 months;
Key exclusion criteria (29 listed)
- 1.have used Anlotinib 、Docetaxel before；
- 2.Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- 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.History and comorbidities
- 5.The discretion of the investigator, the patient may have other factors that may cause the study to be terminated, such as other serious illnesses or serious laboratory abnormalities, or family or society factors;
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 DocetaxelAnlotinib ( 12mg, QD, PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2, IV, d1, 21 days per cycle) | Drug | Anlotinib combined Docetaxel |
| DocetaxelDocetaxel (75mg/m2, IV, d1, 21 days per cycle) | Drug | Docetaxel |
Primary outcome
PFS
Time frame: Each 42 days up to PD or death(up to 24 months)
Progress free survival
4 secondary outcomes
OS
Time frame: From randomization until death (up to 24 months)
ORR
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)
Safety and Tolerability: Number of Participants with Adverse Events
Time frame: Until 30 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 28 Nov 2018.
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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.
Yunpeng Liu, PhD principal investigator
China Medical 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 2 study testing Anlotinib combined Docetaxel and Docetaxel in people with Non-small Cell Lung Cancer, run by China Medical University, China 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 15 inclusion and 29 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 28 Nov 2018. 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 Xiujuan Qu, PhD (024-83282542, qu_xiujuan@hotmail.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 28 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.