- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766490
Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer
January 28, 2019 updated by: The First Affiliated Hospital of Soochow University
A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer
After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high.
Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit.
This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer .
The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Min Tao, Doctor
- Phone Number: 008613962125300
- Email: taomin@suda.edu.cn
Study Locations
-
-
Jangsu
-
Suzhou, Jangsu, China
- The First Affiliated Hospital of Soochow University
-
Contact:
- Min Tao, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must have histlogically confirmed stage IV non-small cell lung cancer .
- The initial treatment with gefitinib/icotinib evaluated PR/NC and the efficacy lasted for more than 6 months, then the disease progressed later. (The efficacy was assessed as PD according to the evaluation standard of RECIST1.1)
- At least a measurable lesion that meets the RECIST 1.1 criteria.
- Any gender. Age ≥18 years and ≤75 years
- Life expectancy >3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment.
- Adequate organ function: haemoglobin ≥ 90 g/L;neutrophils count ≥1.5×109/L; platelet count ≥ 90 × 109/L; total bilirubin ≤ 1.5 × ULN ;ALT < 2 × ULN, (ALT < 5 × ULN, for those with liver metastases);AST < 2 × ULN, (AST < 5 × ULN, for those with liver metastases); Cr≤1.5× ULN.
- Echocardiography : LVEF≥50%
- 12-leads electrocardiogram : QTcF<450ms (man), <470ms(woman)
- Patient informed consent and signed written consent
- Patient compliance was good and voluntary follow-up, treatment, laboratory testing, and other research steps were performed as planned.
Exclusion Criteria:
- The patient has previously received anti-tumor therapy for EGFR TKIs other than gefitinib and ectinib for lung cancer.
- Patients that cannot detect EGFR gene, or patients with known T790M mutation.
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer).
- CT or MRI shows that the tumor lesion is ≤ 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor.
- Active brain metastasis, cancerous meningitis, spinal cord compression patients.
- Other active malignancies that require simultaneous treatment.
- Has a history of malignant tumors in the past 5 years.
- Patients with previous anti-tumor treatment-related adverse reactions who have not recovered to NCI-CTC AE≤1.
- Abnormal coagulation ,with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
- Renal insufficiency: urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g, or creatinine clearance <60ml / min.
- Severe acute or chronic infection requiring systemic treatment.
- Suffering from severe cardiovascular disease: myocardial ischemia ,myocardial or arrhythmia.
- Clinically significant hemoptysis occurred within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or a clear tendency to hemorrhage.
- Untreated active hepatitis : Hepatitis B or Hepatitis C
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib Hydrochloride plus gefitinib or icotinib
|
Capsule, P.O.
12mg qd ,days 1-14, 21 days a cycle
Tablet, P.O. 250mg qd
Tablet, P.O. 125mg tid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS(Progress free survival)
Time Frame: each 42 days up to PD or death(up to 24 months)
|
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
|
each 42 days up to PD or death(up to 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior
to progression or any further therapy.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
|
OS is defined as the time until death due to any cause.
|
From randomization until death (up to 24 months)
|
Quality of Life(QoL)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Disease Control Rate (DCR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Min Tao, Doctor, The First Affiliated Hospital of Soochow University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 30, 2019
Primary Completion (Anticipated)
December 20, 2019
Study Completion (Anticipated)
December 20, 2020
Study Registration Dates
First Submitted
December 2, 2018
First Submitted That Met QC Criteria
December 5, 2018
First Posted (Actual)
December 6, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
December 1, 2018
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
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Gefitinib
Other Study ID Numbers
- ALTER-L010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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