Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin

Sponsor
Third Military Medical University
Study ID
NCT02875457
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. Etoposide and cisplatin chemotherapy is the first-line treatment for small-cell lung cancer. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of apatinib as the maintenance therapy for extensive stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.

Key Dates

Start date
Sep 30, 2016
Status verified
Aug 2016
Primary completion
Sep 30, 2018
Completion
Sep 30, 2023

Study Design

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

Arms

  • Experimental: Arm A
    Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and apatinib 250mg/d , repeated every 21 days, a total of 6 cycles, and then continue to take apatinib 250mg/d until progressive Disease(PD).
  • Placebo Comparator: Arm B
    Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, and placebo, repeated every 21 days, a total of 6 cycles, and then continue to take placebo until PD.

Primary Outcome Measure

Progression-free survival [ Time Frame: 6 months ]

Central Contacts

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