Actively Recruiting
Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
Led by Emory University · Updated on 2025-10-31
22
Participants Needed
3
Research Sites
261 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Pathologically confirmed extensive stage small cell lung cancer (ES-SCLC) after progression on first-line systemic therapy
- Presence of metastatic bone or visceral/lung disease confirmed by imaging within 90 days before radiotherapy
- Patients with treated brain metastases requiring less than 10 mg dexamethasone daily or equivalent
- Absolute neutrophil count (ANC) of at least 1,500 cells/mm³
- Platelet count of at least 100,000 cells/mm³
- Hemoglobin greater than 7.0 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN)
- AST/ALT less than or equal to 3.0 times ULN (or 5.0 times ULN if liver involvement)
- Alkaline phosphatase less than or equal to 2.5 times ULN (or 5.0 times ULN with documented liver or bone metastases)
- Female participants of childbearing potential must have a negative pregnancy test before starting therapy
- Use of effective contraception by females of childbearing potential and men during and for a specified period after study participation
- Completion of all previous cancer therapies (except lurbinectedin) at least 3 weeks before starting study therapy
- Willingness and ability to comply with study visits, drug administration, laboratory tests, and procedures
- Signed informed consent indicating understanding of study risks, benefits, and procedures
You will not qualify if you...
- Pregnancy or breastfeeding within 2 weeks prior to study entry
- Enrollment in both safety cohorts is not allowed
- For patients with prior radiotherapy, treated metastases must be more than 2 cm away from previously irradiated critical structures including spinal cord, brachial plexus, intestines, stomach, brainstem, and lungs with specified radiation dose limits
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Not Yet Recruiting
Research Team
K
Kristin Higgins, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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