- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03781869
Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
December 18, 2018 updated by: Dong Wang, Third Military Medical University
A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer.
A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy.
The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
116
Phase
- Phase 2
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
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of small cell lung caner
- Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1)
- Males or females between 18 Years to 75 Years.
- Performance status of 0~2 on the ECOG criteria.
- Main organs function is normal
- Expected survival is above three months.
- with asymptomatic brain metastases.
- At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion >= 20mm or spiral CT >=10mm).
Adequate hematologic (Leukocyte count >= 4.0×109/L, neutrophil count>=2.0×109/L, hemoglobin>=95g/L, platelets>=100×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT)
=<upper normal limit(UNL) x1.5, bilirubin level =< UNL x 1.5).
- Patient can take oral medicine.
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Exclusion Criteria:
- History of cardiovascular disease: congestive heart failure (CHF) > New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
- Serious clinical infection (> NCI-CTCAE version 4.0 ,infection standard II).
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- The patients had accepted allogeneic organ transplantation.
- Bleeding tendency or coagulation disorders.
- patients who need renal dialysis.
- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).
- pulmonary hemorrhage >CTCAE grade 2 within 4 weeks before first use of drugs.
- Other organ hemorrhage >CTCAE grade 3 within 4 weeks before first use of drugs.
- severe uncured wounds, ulcers or fracture.
- uncured dehydration.
- Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.
- Patients are allergic to drugs used in research.
- Factors influencing the safety and compliance of patients.
- Inability to comply with protocol or study procedures.
- Pregnant or breast-feeding.
- The researcher believe that the Patient is not suitable to participate in the study.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib + Chemotherapy
Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD).
|
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days
|
Placebo Comparator: Chemotherapy
Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD.
|
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: From randomization,each 42 days up to PD or death(up to 24 months
|
The first day of treatment to the date that disease progression is reported
|
From randomization,each 42 days up to PD or death(up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: From randomization until death (up to 5 years)
|
The first day of treatment to death or last survival confirm date
|
From randomization until death (up to 5 years)
|
Objective Response Rate
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
|
Treatment-related adverse events
Time Frame: the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months
|
Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.
|
the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months
|
Performance Status
Time Frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months
|
Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).
|
the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months
|
Disease Control Rate
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
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.
Investigators
- Principal Investigator: Dong Wang, PH.D, Daping Hospital, Third Military Medical University, Chongqing,China
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)
December 1, 2018
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
December 18, 2018
First Submitted That Met QC Criteria
December 18, 2018
First Posted (Actual)
December 20, 2018
Study Record Updates
Last Update Posted (Actual)
December 20, 2018
Last Update Submitted That Met QC Criteria
December 18, 2018
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
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Etoposide phosphate
- Cisplatin
Other Study ID Numbers
- ALT-SCLC-01
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.
Clinical Trials on Extensive-stage Small Cell Lung Cancer
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Zhejiang Cancer HospitalRecruitingExtensive Stage Lung Small Cell CancerChina
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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National Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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National Cancer Institute (NCI)CompletedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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