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
52 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
Researchers are evaluating the safety of combining palliative radiotherapy with the drug lurbinectedin to treat extensive stage small cell lung cancer that has spread beyond the chest and progressed after chemotherapy. Lurbinectedin works by blocking a process essential for tumor cell survival and damaging tumor DNA, similar to how radiation kills cancer cells. Palliative radiotherapy is used to relieve symptoms caused by metastatic lung cancer or to prevent symptoms from developing. This phase I trial aims to understand if these treatments together improve effects or cause more side effects. Patients receive palliative radiotherapy over 5 or 10 daily treatment sessions within 21 days, based on physician choice. They also get lurbinectedin through an intravenous infusion lasting 1 hour on the first day of each 21-day treatment cycle. Treatment cycles continue if the disease does not progress and side effects remain acceptable. After radiotherapy completion, patients have follow-up visits at 1, 3, 6, and 12 months. During the study, participants are monitored for adverse events related to the combined treatment for up to one year. Researchers assess tumor response through imaging, pain relief, progression-free survival, overall survival, and patient-reported side effects. The trial also explores how radiation dose to bone marrow relates to blood toxicity. This comprehensive monitoring helps understand safety, feasibility, and early signs of treatment effectiveness.
CONDITIONS
Brief 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 progressing after first-line systemic therapy
- Presence of metastatic bone or visceral/lung disease confirmed by imaging within 90 days prior to radiotherapy
- Patients with treated brain metastases requiring less than 10 mg daily dexamethasone or equivalent
- Absolute neutrophil count (ANC) of 1,500 cells/mm³ or higher
- Platelet count of 100,000 cells/mm³ or higher
- Hemoglobin level greater than 7.0 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 times ULN (or 5.0 times ULN if liver involved)
- Alkaline phosphatase less than or equal to 2.5 times ULN (or 5.0 times ULN with documented liver or bone metastases)
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during the study and for 6 months after final dose (for females) or 4 months after (for males)
- Completion of prior cancer therapies (except lurbinectedin) at least 3 weeks before starting study treatment
- Willingness and ability to comply with study visits, drug administration, laboratory tests, and procedures
- Signed informed consent acknowledging understanding of study procedures and risks
You will not qualify if you...
- Pregnancy or breastfeeding within 2 weeks prior to study entry
- Enrollment in both safety cohorts simultaneously
- Metastases to be treated located within 2 cm of previously irradiated structures including spinal cord, brachial plexus, small or large intestine, stomach, brainstem, or lungs beyond specified radiation dose limits
- Prior radiation doses exceeding specified thresholds to critical organs as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive palliative radiation therapy over 5 or 10 treatment fractions daily for 21 days combined with lurbinectedin given intravenously every 21 days in cycles, continuing until disease progression or unacceptable toxicity.
Daily visits for radiation therapy over 21 days and 1 intravenous lurbinectedin infusion per 21-day cycle
Duration - Up to 12 months
Participants are followed up after completion of palliative radiation therapy to monitor safety, efficacy, and patient-reported toxicities.
Visits at 1, 3, 6, and 12 months post-radiation therapy
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here