NCT06501976

An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat locally-advanced SCLC after first-line therapy. This study will enroll patients with thoracic disease but no distant metastases after first line treatment failure. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC, but the combination is always toxic. This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects.

Detailed description

PRIMARY OBJECTIVE: To describe the safety in terms of radiation therapy (RT) in combination with lurbinectedin in patients with locally-advanced SCLC after first-line therapy. SECONDARY OBJECTIVES: To evaluate the preliminary efficacy of RT plus lurbinectedin, as assessed by Progression free survival (PFS) and Overall survival (OS). OUTLINE: Patients receive 2 cycles of lurbinectedin combined with thoracic radiotherapy followed by 2 cycles of lurbinectedin alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. G-CSF（Granulocyte Colony-Stimulating Factor） will be used for prophylaxis.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Lurbinectedin	2.6 mg/m2 , Given IV, every 21 days
RADIATION	Radiation Therapy	Thoracic radiotherapy

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2024-07-15
• Last updated: 2024-07-15