NCT03613753

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

A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: ShengFa Su · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems. While there still is no consensus on second-line therapy. Clinical studies have demonstrated that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed cross-resistance to carboplatin and cisplatin. Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models, which overcomes some forms of cisplatin or carboplatin resistance in preclinical tumour models. Retrospective studies also have demonstrated the efficacy of Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent SCLC.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	irinotecan plus lobaplatin	irinotecan plus lobaplatin chemotherapy
DRUG	irinotecan	irinotecan chemotherapy alone

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-06-01
• Completion: 2021-06-01
• First posted: 2018-08-03
• Last updated: 2020-02-05

Locations

1 site across 1 country: China