Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
NCT ID: NCT03781869
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
116 participants
INTERVENTIONAL
2018-12-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
Anlotinib Hydrochloride; etoposide and cisplatin
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
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 and cisplatin
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
Interventions
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Anlotinib Hydrochloride; etoposide and cisplatin
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
etoposide and cisplatin
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Dong Wang
chief physician
Principal Investigators
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Dong Wang, PH.D
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital, Third Military Medical University, Chongqing,China
Central Contacts
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Other Identifiers
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ALT-SCLC-01
Identifier Type: -
Identifier Source: org_study_id