Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.

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

Details

• Lead Sponsor: ShengFa Su
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Relapsed SCLC

• Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC

• At least 30 days after the completion of first-line chemotherapy

• Either sex, age between 18 to 70 years

• Expected life time ≥ 3 months

• Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.

• Adequate bone marrow and organ function as defined below:

Neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L; AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range; Creatinineconcentration ≤120 μmol/L

• Had measurable or assessable disease

Exclusion Criteria:

• Concomitant with other malignant disease

• Pregnancy or lactation at the time of enrollment

• Any contraindications for chemotherapy

• Received target therapy or immunotherapy