Extensive-stage Small Cell Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer; Anlotinib; Maintenance therapy
Brief summary
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.
Interventions
DRUGAnlotinib 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 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From randomization until death (up to 5 years) | The first day of treatment to death or last survival confirm date |
| Objective Response Rate | each 42 days up to intolerance the toxicity or PD (up to 24 months) | — |
| Treatment-related adverse events | 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. |
| Performance Status | 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). |
| Disease Control Rate | each 42 days up to intolerance the toxicity or PD (up to 24 months) | — |
Contacts
Primary ContactDong Wang, PH.D.
Outcome results
None listed