Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer

Sponsor
First Hospitals affiliated to the China PLA General Hospital
Study ID
NCT02980809
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.

Key Dates

Start date
Mar 31, 2017
Status verified
Nov 2016
Primary completion
Mar 31, 2019
Completion
Mar 31, 2020

Study Design

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

Arms

  • Experimental: Apatinib and topotecan
    Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.
  • Placebo Comparator: Topotecan
    Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.

Primary Outcome Measure

Progression-free survival [ Time Frame: 1 year ]

Central Contacts

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