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

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT05244239
Trial Phases:	Phase I	Protocol IDs:	RAD5466-21 (primary) NCI-2021-12410 STUDY00003528
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05244239

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.