NCT07376499

Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of liposome irinotecan combined with platinum and immune checkpoint inhibitor combined with antirotinib maintenance therapy after first-line induction

Detailed description

1. Irinotecan hydrochloride liposome injection combined with platinum and tislelizumab therapy in a 3-week treatment cycle , 4 cycles Drug: Liposome irinotecan(50mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle Drug: Carboplatin (AUC 4-5) or Cisplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle Drug: Toripalimab (240mg) will be administered by intravenous infusion on day 1 in a 3 week treatment cycle 2. Maintenance treatment, to disease progression or AE Drug: Toripalimab (240mg) will be administered by intravenous infusion on day 1 in a 3 week treatment cycle Drug: Anlotinib (8mg) will be administered orally in a 3-week treatment cycle, once a day from day 1 to day 14 of each cycle

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Liposome Irinotecan	Liposome irinotecan(50mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle
DRUG	Platinum	Carboplatin (AUC 4-5) or Cisplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 3 week treatment cycle
DRUG	Anlotinib	Anlotinib (8mg) will be administered orally in a 3-week treatment cycle, once a day from day 1 to day 14 of each cycle
DRUG	Toripalimab	Toripalimab (240mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

Timeline

• Start date: 2026-01-25
• Primary completion: 2026-03-31
• Completion: 2027-06-30
• First posted: 2026-01-29
• Last updated: 2026-01-29