Combining palliative radiotherapy with lurbinectedin for extensive stage small cell lung cancer
A Phase I Study of Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
This study is testing if combining palliative radiotherapy with the drug lurbinectedin can help people with advanced small cell lung cancer feel better after their chemotherapy has stopped working.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT05244239 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and feasibility of administering palliative radiotherapy alongside lurbinectedin in patients with extensive stage small cell lung cancer that has progressed after chemotherapy. The study aims to evaluate whether this combination can enhance treatment efficacy compared to using either treatment alone, while also monitoring for potential side effects. Patients will receive palliative radiotherapy over a period of 21 days and lurbinectedin intravenously every 21 days, with follow-up assessments at multiple intervals to track outcomes and toxicities.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed extensive stage small cell lung cancer who have progressed after first-line therapy.
Not a fit: Patients with early-stage lung cancer or those not eligible for lurbinectedin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve symptom relief and overall survival for patients with advanced small cell lung cancer.
How similar studies have performed: While the combination of palliative radiotherapy and lurbinectedin is a novel approach, previous studies have shown promise in using lurbinectedin for small cell lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Not_yet_recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Kristin Higgins, MD — Emory University
- Study coordinator: Kristin Higgins, MD
- Email: Kristin.higgins@emory.edu
- Phone: 404.778.3473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.