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Palliative Radiotherapy with Lurbinectedin for Extensive Stage Small Cell Lung Cancer

This study is looking at whether it is safe to combine palliative radiation therapy with a drug called lurbinectedin for patients with extensive stage small cell lung cancer. This is lung cancer that has spread outside the chest and has grown after initial chemotherapy. Lurbinectedin works by damaging cancer cell DNA and blocking a process cancer cells need to survive. Radiation also damages cancer cell DNA. Palliative radiation is used to help relieve symptoms. The study aims to see how well patients tolerate this combination and if it helps shrink tumors, reduce pain, and improve how long patients live without their cancer getting worse. About 22 patients are expected to join.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is not specified if it's a randomized or blinded study, or its phase.
What's involved
You would receive palliative radiation therapy daily for 5 or 10 sessions over 21 days, and lurbinectedin intravenously every 21 days. This continues as long as the treatment is working and you tolerate it.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would have follow-up visits at 1, 3, 6, and 12 months.

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NCT05244239

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Emory University
~22 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:LurbinectedinPalliative Radiation Therapy

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin
Measured over Up to 1 year

Conditions

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

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

3 sites across 1 states
Georgia3

Study leadership

  • Kristin Higgins, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Kristin Higgins, MD
[email protected]
404.778.3473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
Patients with pathologically confirmed ES-SCLC who are receiving lurbinectedin or are candidates for lurbinectedin therapy after progression on first-line systemic therapy (either chemotherapy \[platinum etoposide\] or chemoimmunotherapy) at the discretion of the treating medical oncologist.
Metastatic bone or visceral/lung metastatic disease as assessed computed tomography (CT), magnetic resonance imaging (MRI), bone scan or positron emission tomography (PET)/CT within 90 days prior to RT on this study.
Patients with treated brain metastases are eligible but must require \< 10 mg of dexamethasone daily or its glucocorticoid equivalent. Brain metastases will not be treated in the context of this protocol.
Absolute neutrophil count (ANC) \>= 1,500/cells/mm\^3
Platelets \>= 100,000/cells/mm\^3
Hemoglobin \> 7.0 g/dL
Total Bilirubin ≤ 1.5 ULN
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN (=\< 5.0x ULN for liver involvement)
Alkaline phosphatase =\< 2.5x ULN (=\< 5.0x with documented liver or bone metastases)
Based on its mechanism of action, lurbinectedin could cause harm when administered to a pregnant woman. Taken together with the known teratogenicity of RT, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting protocol therapy. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.
FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 6 months after the final dose of lurbinectedin. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lurbinectedin administration. FCBP who are currently breastfeeding must discontinue during and up to 2 weeks after the final dose of lurbinectedin.
Completion of all previous cancer-directed therapies (excluding lurbinectedin) for the treatment of cancer \>= 3 weeks before the start of study therapy.
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.

Exclusion

Pregnancy or breastfeeding within 2 weeks
Patients may not enroll in both safety cohorts
Patients who have received prior RT will be permitted to enroll. However, the metastases treated on this study must be \> 2 cm from the following previously irradiated structures:
Spinal cord previously irradiated to \> 40 Gy (delivered in =\< 3Gy/fraction)
Brachial plexus previously irradiated to \> 50Gy (delivered in =\< 3Gy/fraction)
Small intestine, large intestine, or stomach previously irradiated to \> 45Gy (delivered in =\< 3Gy/fraction)
Brainstem previously irradiated to \> 50Gy (delivered in =\< 3Gy/fraction)
Lungs previously irradiated with prior V20Gy \> 35 percent (delivered in =\< 3Gy/fraction)

What this trial measures

  • Incidence of adverse events of palliative radio therapy (RT) with lurbinectedinUp to 1 year

    Will be defined as having one or none of the following: * Grade 4 or 5 serious adverse events possibly, probably, or definitely related to protocol treatment from 30 days from the start of RT. * Any adverse events possibly, probably, or definitely related to protocol treatment that leads to prolonged dose delays (defined as with-holding of two consecutive doses of lurbinectedin). * Any adverse event possibly, probably, or definitely related to treatment resulting in the permanent discontinuation of lurbinectedin. Will be analyzed separately for safety cohorts 1 and 2 and will be summarized descriptively using frequencies and percentages. These will be compared to rates reported by Trigo et al. from lurbinectedin monotherapy.