A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

Phase 3

• Conditions: Progression Free Survival
• Interventions: Drug: cisplatin, etoposide; Drug: cisplatin, etoposide, apatinib

• Registration Number: NCT03100955
• Lead Sponsor: Qingdao University

Brief Summary

To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib

Detailed Description

Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-01
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-29
• Last Update Submitted: 2017-03-29
• Study First Posted: 2017-04-04
• Last Update Posted: 2017-04-04
• Primary Completion: 2019-02-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Histologically or cytologically verified SCLC, extensive stages
2. WHO performance status 0, 1, 2
3. Age 18 years or older
4. Treatment naive
5. Anticipated survival more than 3 months
6. HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L
7. No prognancy
8. Signed informed consent

Exclusion Criteria

1. Limited stage disease
2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
3. Uncontrolled hypertension
4. Uncontrolled heart failure
5. Coagulation problem
6. Surgery, trauma, uncontrolled ulcer in 4 weeks.
7. Required by physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EP chemotherapy	cisplatin, etoposide	Standard treatment or active comparator group contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide.
EP chemotherapy plus apatinib	cisplatin, etoposide, apatinib	Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib.

Primary Outcome Measures

Name	Time	Method
progression free survival	24 months	from the date of randomization to disease progression

Trial Locations

Locations (1)

Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China