NCT03100955

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progression Free Survival

Interventions

Type	Name	Description
DRUG	cisplatin, etoposide	The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed.
DRUG	cisplatin, etoposide, apatinib	Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen 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=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-02-01
• Completion: 2019-08-01
• First posted: 2017-04-04
• Last updated: 2017-04-04

Locations

1 site across 1 country: China