Extensive Stage Lung Small Cell CarcinomaPhase 1NCT05244239
Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 1 study testing Lurbinectedin and Palliative Radiation Therapy in people with Extensive Stage Lung Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by Emory University at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Lurbinectedin and Palliative Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jul 2022to 28 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Allyson Anderson, 404-251-2854, allyson.anderson@emory.edu
Hillary Gaines, 404-251-3480, hillary.gaines@emoryhealthcare.org
- Recruiting
Emory University
Atlanta, Georgia, 30322
Allyson Anderson, 404-251-2854, allyson.anderson@emory.edu
Hillary Gaines, 404-251-2854, hillary.gaines@emoryhealthcare.org
- Not yet recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Allyson Anderson, 404-251-2854, allyson.anderson@emory.edu
Hillary Gaines, 404-251-3480, hillary.gaines@emoryhealthcare.org
About this study
Official title: A Phase I Study of Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To describe the safety in terms of palliative radiation therapy (RT) in combination with uninterrupted lurbinectedin in patients with extensive stage-lung small cell carcinoma (ES-SCLC).
SECONDARY OBJECTIVES:
- To determine the feasibility of delivering palliative RT in combination with lurbinectedin.
II. To evaluate the preliminary efficacy of RT plus (+) lurbinectedin, as assessed by:
IIa. Radiographic response rates. IIb. Pain response rates. IIc. Progression free survival (PFS). IId. Overall survival (OS). III. To assess patient-reported toxicities to palliative RT + lurbinectedin.
EXPLORATORY OBJECTIVE:
- To explore the dose-volume relationships between irradiated bone marrow and hematologic toxicity.
OUTLINE:
Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of palliative RT, patients are followed up at 1, 3, 6, and 12 months.
- Being tested
- Lurbinectedin, Palliative Radiation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurbinectedinDrug
Also called PM01183, Zepzelca
Given IV
Palliative Radiation TherapyRadiation
Also called Palliative Radiotherapy
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (lurbinectedin and palliative radiation therapy) | Experimental | Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin IV over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Lurbinectedin; Radiation: Palliative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin
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.
Measured: Up to 1 year
Secondary outcomes (6)
The number of dose reductions or interruptions possibly, probably, or definitely due to the delivery of protocol therapy
Feasibility will be defined as the number of dose reductions or interruptions possibly, probably, or definitely due to the delivery of protocol therapy in the 30 days following completion palliative RT. Will be summarized descriptively using frequencies and percentages.
Measured: 30 days following completion palliative RT
Response rate
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The rate will be reported, along with a 95% confidence interval estimated using the Clopper-Pearson method.
Measured: At 3 months post-RT
Pain response rates
Will be assessed at 3 months post-RT, as assessed by the Brief Pain Inventory (BPI), at 3 months as well as pre-treatment (at registration). The rates will be reported, along with 95% confidence intervals estimated using the Clopper-Pearson method.
Measured: At 3 months pre-treatment and 3 months post-RT
Progression free survival (PFS)
Those alive without disease progression will be censored at last date of disease assessment. PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
Measured: From protocol treatment initiation to disease progression or death, assessed up to 1 year
Overall survival (OS)
Those alive will be censored at date of last follow-up. OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated using the Brookmeyer-Crowley approach.
Measured: From treatment initiation to death, assessed up to 1 year
Patient-reported toxicity
Rates of patient reported outcome (PRO)-adverse events (AEs), will be assessed by PRO-Common Terminology Criteria for Adverse Events (CTCAE) v1.0 and reported using frequencies and percentages.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start27 Jul 2022
- Primary completion28 Jul 2026 (estimated)
- Study completion28 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Lung Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Jazz Pharmaceuticals
- Responsible party
- Principal investigator, Ticiana A. Leal, Emory University
- Investigators
- Kristin Higgins, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244239
- Sponsor's protocol ID
- STUDY00003528
- Other IDs
- NCI-2021-12410, STUDY00003528, RAD5466-21, P30CA138292
- Status last verified
- Oct 2025
- First submitted
- 8 Feb 2022
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05244239
- Acronym / sponsor ID
- STUDY00003528
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Jazz Pharmaceuticals
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 28 Jul 2027 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To describe the safety in terms of palliative radiation therapy (RT) in combination with uninterrupted lurbinectedin in patients with extensive stage-lung small cell carcinoma (ES-SCLC).
SECONDARY OBJECTIVES:
- To determine the feasibility of delivering palliative RT in combination with lurbinectedin.
II. To evaluate the preliminary efficacy of RT plus (+) lurbinectedin, as assessed by:
IIa. Radiographic response rates. IIb. Pain response rates. IIc. Progression free survival (PFS). IId. Overall survival (OS). III. To assess patient-reported toxicities to palliative RT + lurbinectedin.
EXPLORATORY OBJECTIVE:
- To explore the dose-volume relationships between irradiated bone marrow and hematologic toxicity.
OUTLINE:
Patients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of palliative RT, patients are followed up at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (lurbinectedin and palliative radiation therapy) | Experimental | Drug: Lurbinectedin, Radiation: Palliative Radiation TherapyPatients undergo palliative RT over 5 or 10 treatment fractions at the discretion of the treating physician daily for 21 days. Patients also receive lurbinectedin IV over 1 hour on day 1 of each cycle. Cycles of lurbinectedin repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurbinectedinAlso: PM01183, ZepzelcaGiven IV | Drug | Treatment (lurbinectedin and palliative radiation therapy) |
| Palliative Radiation TherapyAlso: Palliative RadiotherapyUndergo RT | Radiation | Treatment (lurbinectedin and palliative radiation therapy) |
Primary outcome
Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin
Time frame: Up 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.
6 secondary outcomes
The number of dose reductions or interruptions possibly, probably, or definitely due to the delivery of protocol therapy
Time frame: 30 days following completion palliative RT
Response rate
Time frame: At 3 months post-RT
Pain response rates
Time frame: At 3 months pre-treatment and 3 months post-RT
Progression free survival (PFS)
Time frame: From protocol treatment initiation to disease progression or death, assessed up to 1 year
Overall survival (OS)
Time frame: From treatment initiation to death, assessed up to 1 year
Patient-reported toxicity
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Higgins, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lurbinectedin and Palliative Radiation Therapy in people with Extensive Stage Lung Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Higgins, MD (404.778.3473, Kristin.higgins@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.