NCT05244239

Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer

A Phase I Study of Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blocks a process called transcription that small cell lung cancer relies on to survive. It also damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Palliative radiotherapy is a routine medical treatment for patients who have lung cancer that has spread to other parts of the body (metastatic), and is used to relieve symptoms caused by cancer or to patients from developing symptoms. This trial may help doctors understand if treating patients with lurbinectedin and palliative radiotherapy at the same time would make them both work better than either one alone or if they could cause more side effects for patients when given together.

Detailed description

PRIMARY OBJECTIVE: I. To describe the safety in terms of palliative radiation therapy (RT) in combination with uninterrupted lurbinectedin in patients with extensive stage-lung small cell carcinoma (ES-SCLC). SECONDARY OBJECTIVES: I. To determine the feasibility of delivering palliative RT in combination with lurbinectedin. II. To evaluate the preliminary efficacy of RT plus (+) lurbinectedin, as assessed by: IIa. Radiographic response rates. IIb. Pain response rates. IIc. Progression free survival (PFS). IId. Overall survival (OS). III. To assess patient-reported toxicities to palliative RT + lurbinectedin. EXPLORATORY OBJECTIVE: I. To explore the dose-volume relationships between irradiated bone marrow and hematologic toxicity. OUTLINE: Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of palliative RT, patients are followed up at 1, 3, 6, and 12 months.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Lurbinectedin	Given IV
RADIATION	Palliative Radiation Therapy	Undergo RT

Timeline

• Start date: 2022-07-27
• Primary completion: 2026-07-28
• Completion: 2027-07-28
• First posted: 2022-02-17
• Last updated: 2025-10-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study