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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib + Chemotherapy | Experimental | 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). |
|
| Chemotherapy | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride; etoposide and cisplatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The first day of treatment to death or last survival confirm date | From randomization until death (up to 5 years) |
| Objective Response Rate | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wang, PH.D. | Contact | 86-23-68757151 | dongwang64@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Wang, PH.D | Daping Hospital, Third Military Medical University, Chongqing,China | Principal Investigator |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| etoposide and cisplatin | Drug | etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days |
|
| Treatment-related adverse events | 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 | 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 | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |