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

October 29, 2025 updated by: Ticiana A. Leal, Emory University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment (lurbinectedin and palliative radiation therapy)
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.
Drug: Lurbinectedin
Given IV
Other Names:
  • PM01183
  • Zepzelca
Radiation: Palliative Radiation Therapy
Undergo RT
Other Names:
  • Palliative Radiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
30 days following completion palliative RT
Response rate
Time Frame: At 3 months post-RT
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.
At 3 months post-RT
Pain response rates
Time Frame: At 3 months pre-treatment and 3 months post-RT
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.
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
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.
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
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.
From treatment initiation to death, assessed up to 1 year
Patient-reported toxicity
Time Frame: Up to 1 year
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.
Up to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hematologic toxicity rate
Time Frame: Up to 1 year
Rates of hematologic toxicity (grade 3+) as a function of dose-volume relationships of irradiated bone marrow volume will be reported, using frequencies and percentages.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Jazz Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristin Higgins, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003528 (Other Identifier: Emory University)
  • P30CA138292 (U.S. NIH Grant/Contract)
  • NCI-2021-12410 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RAD5466-21 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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