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

Sponsor
Qingdao University
Study ID
NCT03100955
Phase
PHASE3
Status
Unknown

Conditions

  • Progression Free Survival

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cisplatin, etoposide — DRUG
    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.
  • cisplatin, etoposide, apatinib — DRUG
    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.

Study Details

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

Key Dates

Start date
Mar 1, 2017
Status verified
Mar 2017
Primary completion
Feb 1, 2019
Completion
Aug 1, 2019

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: EP chemotherapy
    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.
  • Experimental: EP chemotherapy plus 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 Measure

progression free survival [ Time Frame: 24 months ]

Central Contacts