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Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

Primary Purpose

Extensive-stage Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Anlotinib Hydrochloride; etoposide and cisplatin

etoposide and cisplatin

About this trial

This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer; Anlotinib; Maintenance therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anlotinib + Chemotherapy

Chemotherapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Progression-free survival

The first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Overall survival

The first day of treatment to death or last survival confirm date

Objective Response Rate

Treatment-related adverse events

Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.

Performance Status

Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).

Disease Control Rate

Full Information

NCT ID

NCT03781869

First Posted

December 18, 2018

Last Updated

December 18, 2018

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03781869

Brief Title

Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2018 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extensive-stage Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; Anlotinib; Maintenance therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anlotinib + Chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Chemotherapy

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Anlotinib Hydrochloride; etoposide and cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

etoposide and cisplatin

Intervention Description

etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days

Primary Outcome Measure Information:

Title

Progression-free survival

Description

The first day of treatment to the date that disease progression is reported

Time Frame

From randomization，each 42 days up to PD or death(up to 24 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

The first day of treatment to death or last survival confirm date

Time Frame

From randomization until death (up to 5 years)

Title

Objective Response Rate

Time Frame

each 42 days up to intolerance the toxicity or PD (up to 24 months)

Title

Treatment-related adverse events

Description

Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.

Time Frame

the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months

Title

Performance Status

Description

Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).

Time Frame

the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months

Title

Disease Control Rate

Time Frame

each 42 days up to intolerance the toxicity or PD (up to 24 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Wang, PH.D.

Phone

86-23-68757151

dongwang64@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Wang, PH.D

Organizational Affiliation

Daping Hospital, Third Military Medical University, Chongqing,China

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

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