New combo aims to ease symptoms in advanced lung cancer
NCT ID NCT05244239
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether giving palliative radiotherapy together with the drug lurbinectedin is safe for people with extensive-stage small cell lung cancer that has spread beyond the chest. The goal is to relieve symptoms caused by the cancer. About 22 adults whose cancer worsened after initial chemotherapy will receive both treatments to see if the combination causes more side effects or works better than either alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Saint Joseph's Hospital
NOT_YET_RECRUITINGAtlanta, Georgia, 30342, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Emory University Hospital Midtown
NOT_YET_RECRUITINGAtlanta, Georgia, 30308, United States
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Other studies related to the condition(s) this trial covers.
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