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

First Hospitals affiliated to the China PLA General Hospital

Status and phase: Unknown; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Topotecan; Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02980809

gsk-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Apatinib and topotecan

Experimental group

Description:

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.

Treatment:

Drug: Apatinib

Drug: Topotecan

Topotecan

Placebo Comparator group

Description:

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.

Treatment:

Drug: Topotecan