Combining liposomal irinotecan and apatinib for advanced small cell lung cancer

Study of Liposomal Irinotecan Combined with Apatinib in the Treatment of Extensive Stage Small Cell Lung Cancer After First-line Progression

This study is testing if combining two drugs, liposomal irinotecan and apatinib, can help people with advanced small cell lung cancer who haven't responded to their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: ranibizumab, apatinib, anlotinib, lenvatinib, sunitinib, chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06749691 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of liposomal irinotecan in combination with apatinib for patients with extensive stage small cell lung cancer (SCLC) who have progressed after first-line treatment. Small cell lung cancer is known for its rapid progression and poor prognosis, making effective second-line treatment crucial. The study explores the potential benefits of using liposomal irinotecan, which enhances drug stability and targeting, alongside apatinib, a tyrosine kinase inhibitor that targets tumor blood supply. By combining these therapies, the study seeks to improve patient outcomes and quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with measurable lesions who have experienced disease progression after first-line treatment.

Not a fit: Patients who have previously received anti-VEGF or anti-VEGFR treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could extend survival and improve the quality of life for patients with advanced small cell lung cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of chemotherapy and anti-angiogenic agents in various cancers, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age range of 18-75 years;
2. Expected survival period ≥ 12 weeks;
3. At least one measurable lesion (according to RECIST V 1.1);
4. For patients who have failed first-line or second-line treatment.

Exclusion Criteria:

1. Have received any systemic treatment targeting VEGF or VEGFR in the past, such as treatment with anti angiogenic drugs such as ranibizumab, fipronib, apatinib, anlotinib, lenvatinib, sunitinib, sorafenib.
2. Active or uncontrolled severe infection (CTCAE 5.0 ≥ 2) and/or antibiotic treatment within 2 weeks prior to enrollment;
3. There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
4. Those deemed unsuitable for inclusion by doctors;

Where this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xian Zhong

Conditions Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer; Liposomal Irinotecan; Apatinib