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

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Hospitals affiliated to the China PLA General Hospital
• Treatments: Apatinib; Topotecan

Criteria

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.