The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer

NCT03129698 | Unknown Phase 2

• 1 other identifier: CH-L-066-SL
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.

Conditions

Apatinib in Maintenance Treatment

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  6 months

Secondary Outcomes (2)

• Number of participants with Adverse events

  6 months

• Overall Survival

  1 year

Study Arms (1)

Formerly Arm Label

OTHER

Apatinib 250mg daily

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib 250mg daily

Formerly Arm Label

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed small-cell lung cancer and extensive stage (extrathoracic metastatic disease, malignant pleural effusion, contralateral supraclavicular adenopathy, or contralateral hilar adenopathy)
• Having a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy, or combining sequential radiotherapy
• Prior treatment without c-kit targeted drugs
• Life expectancy of more than 3 months
• Age ≥ 18 years
• Oncology Group performance status of 0 to 2
• Informed consent.

You may not qualify if:

• Mixed lung cancer or other types of lung cancer
• Have previously received c-kit targeted drugs
• Hemoglobin\<8.0 g/dL, white blood cell \<3 X 10\^9/L, platelet count \<75 X 10\^9/L, alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Patients had recent major surgery, significant hemoptysis ( 5 ml), open wounds, or brain metastases present on required pre-enrollment brain imaging or required full-dose anticoagulation
• Uncontrol hypertension, \>160/100 mmHg after treatment
• Pregnant or lactating patients
• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) infection
• Patients who are suffering from serious autoimmune disease
• Patients who had active infection
• Patients who are suffering from serious organ dysfunction
• Patients who are suffering from other cancer
• Other situations that the researchers considered unsuitable for this study.
• Other concurrent uncontrolled illness

Sponsors & Collaborators

• Junling Li: lead

Study Sites (1)

Junling Li

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

apatinib

Central Study Contacts

Junling Li, doctor

CONTACT

+86 13801178891; lijunling@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients with untreated extensive-stage small-cell lung cancer

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: April 26, 2017
• Study Start: April 11, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

CN (1)