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

Study Overview
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Brief Summary
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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.

Detailed Description
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Small-cell lung cancer (SCLC) is an aggressive tumor and most patients experienced relapse or progression after standard chemotherapy. Topotecan is active as second-line therapy for SCLC patients. However, even in sensitive patients, only 20% response rate and a median time to progression of 12 weeks are observed. New therapeutic options in SCLC are needed. Apatinib is a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor 2. It has been approved in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The efficacy of apatinib in SCLC is unknown. 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.

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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Apatinib
* Drug: Topotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: limited or extensive-stage SCLC who had failed to first-line therapy ≥18 years old Eastern Cooperative Oncology Group performance status ≤2 at least one measurable lesion as defined by RECIST (version 1.1) at least one measurable lung tumor lesion WBC count ≥3,500/μL, neutrophils ≥1,500μL, platelets ≥100,000μL, hemoglobin ≥ 9.0 g/dL AST, and ALT ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with liver metastases. Exclusion Criteria: symptomatic CNS metastases concomitant or previous malignancies within the last 5 years severe comorbidities; prior topotecan therapy hypersensitivity or other contraindication to the study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib and topotecan<br>Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression. | Drug: Apatinib<br> <br> Drug: Topotecan<br> <br> |
| Placebo Comparator: Topotecan<br>Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression. | Drug: Topotecan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1 year | 
| Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0 | Toxicity is assessed by common terminology criteria for adverse events(CTCAE) V4.0 | 1 year |