- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624309
Anlotinib Plus Docetaxel for the Treatment of EGFR Wild-type Advanced Non-small-cell Lung Cancer
Anlotinib Plus Docetaxel Versus Docetaxel for Treatment of EGFR Wild-type Advanced Non-small-cell Lung Cancer After Disease Progression on Platinum-based Therapy : a Multicentre, Double-blind, Randomised Explorative Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a multicentre randomised controlled clinical trial conducted in China to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR wild-type Advanced Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A and arm B:
Arm A: Patients on the anlotinib and docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle and 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle.
Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Hunan
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Changsha, Hunan, China, 410000
- Recruiting
- Hunan Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- signed and dated informed consent
- diagnosed with advanced NSCLC (phase IIIB/IIIC/IV) through pathology, with measurable nidus(using RECIST 1.1)
- have failed for platinum two drugs chemotherapy
- EGFR wild type
- ECOG PS:0-1,Expected Survival Time: Over 3 months
- main organs function is normal
- 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 2 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 2 months after it
Exclusion Criteria:
- Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
- have used docetaxel before
- have used antiangiogenic drugs (except Bevacizumab or endostatin)
- have failed for two times or beyond of platinum two drugs chemotherapy(except adjunctive therapy,neoadjuvant therapy and concurrent chemoradiotherapy )
- iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
- patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease) (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
- patients are participating in other clinical studies (other than non-interventional studies) less than 4 weeks from the end of a previous clinical study
- other kinds of malignancies within 5 years or for now
- have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
- urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
- uncontrollable hypertensive (systolic blood pressure or greater 150 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
- the effects of surgery or trauma had been eliminated for less than 14 days before admission to the study group
- patients with severe infections , and need to receive Systemic antibiotic treatment
- significant cardiac disease as defined as: grade II or greater myocardial infarction, unstable arrhythmia(Including corrected QT interval (QTc )period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction (LVEF)Less than 50%
- patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
- pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
- serious, non-healing wound, ulcer, or bone fracture
- decompensated diabetes or high dose glucocorticoid treatment of other contraindication
- has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
- has Clinically significant hemoptysis Within 3 months before Random (daily hemoptysis than 50 ml;Or significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of fecal occult blood, or vasculitis, etc
- has venous thromboembolism events Within 12 months before Random, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
- whole body antitumor treatment was planned in the first 4 weeks(except diphosphonate) or during this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, Chinese medicine with antitumor effect. Field scale radiotherapy (EF-RT) within 4 weeks before grouping or limited field radiotherapy before grouping were carried out in 6 months ;
- a known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS)
- untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection
- serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib Plus Docetaxel
Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
|
Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
Other Names:
|
Active Comparator: Docetaxel
Docetaxel (75mg/m2 IV d1)
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Docetaxel (75mg/m2 IV d1)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: each 42 days up to PD or death(up to 24 months)
|
Progress free survival
|
each 42 days up to PD or death(up to 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: From randomization until death (up to 24 months)
|
Overall Survival
|
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)
|
Objective Response Rate
|
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)
|
Disease Control Rate
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
Time Frame: Until 21 day safety follow-up visit
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
|
Until 21 day safety follow-up visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: LIN WU, professor, Hunan cancer hospital,Tongzipo Road 283#, Hunan,China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- ALTER-L018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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