Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer (LUPINE)

June 5, 2026 updated by: Chang Gon Kim, Yonsei University

Lurbinectedin in Combination With Paclitaxel Versus Paclitaxel for Patients With Previously Treated Small Cell Lung Cancer: Randomized, Phase II, Open-label, Multi-center, Prospective Trial(LUPINE)

This clinical trial is designed to compare and evaluate the efficacy and safety of the combination therapy of Lurbinectedin plus Paclitaxel (Combination Arm) versus Paclitaxel monotherapy (Monotherapy Arm) in patients with extensive-stage small-cell lung cancer whose disease has progressed after first-line chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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.
69

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 2

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.
  • Name: Hye Ryun Kim
  • Phone Number: 82-2-2228-8125
  • Email: nobelg@yuhs.ac

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 19 years.
  2. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).

  3. Patients who have experienced disease progression following at least one prior platinum-based systemic therapy for extensive-stage small cell lung cancer, including all of the following conditions:

    • Patients who failed treatment within 6 months after curative-intent chemotherapy are considered as having failed first-line therapy.
    • For platinum-sensitive patients, participation in the third-line cohort is allowed after re-treatment with a platinum-based regimen as second-line therapy (limited-stage).
    • For platinum-resistant patients, participation in the second-line cohort is allowed (limited-stage).
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  5. At least one measurable target lesion according to RECIST v1.1 criteria.
  6. Predicted life expectancy of at least 12 weeks (3 months).

  7. Adequate hematologic, renal, metabolic, and hepatic function within 14 days prior to enrollment, defined as:

    Absolute neutrophil count (ANC) ≥ 1,500/μL Platelet count ≥ 100,000/μL Hemoglobin (Hb) ≥ 9.0 g/dL Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (cCr) ≥ 60 mL/min Total bilirubin ≤ 1.0 × ULN AST and ALT ≤ 3.0 × ULN (regardless of liver metastasis) PT and aPTT ≤ 1.5 × ULN

  8. Willingness to provide unstained slides (minimum 5, ideally 15) from archived or freshly biopsied tissue for exploratory analyses.

  9. Female participants of childbearing potential must have a negative pregnancy test (urine) at screening. If the urine test is positive or inconclusive, a negative serum pregnancy test is required.

    Female participants of childbearing potential must agree to use effective contraception during the study.

  10. Male participants of reproductive potential must agree to use effective contraception during the study (see appendix for acceptable methods).
  11. Voluntary written informed consent to participate in this clinical trial.

Exclusion Criteria:

  1. Patients who have not received prior systemic therapy for small cell lung cancer (SCLC).
  2. Patients previously treated with Lurbinectedin or Paclitaxel.
  3. Patients with limited-stage small cell lung cancer (LS-SCLC).
  4. Patients with symptomatic or clinically significant brain metastases (patients with asymptomatic or stable brain metastases may be eligible; any treatment for brain metastases must have been completed at least 1 week prior to the first dose of study drug).
  5. Concomitant use of medications that may prolong the QTc interval, potent immunosuppressive agents, or drugs that may cause interstitial lung disease (ILD) is prohibited during the treatment period. If co-administration is unavoidable, prior discussion with the coordinating center is required.

  6. Patients with active primary immunodeficiency (e.g., HIV infection), active hepatitis B, or active hepatitis C:

    • HBsAg-positive patients may be eligible if HBV DNA is negative or appropriate antiviral therapy is being administered.
    • HCV antibody-positive patients may be eligible if HCV RNA is negative or the patient has been cured after treatment.
  7. Patients with active interstitial lung disease (ILD) or a history of non-infectious pneumonitis requiring steroid therapy, including immune-therapy- or chemotherapy-related ILD or Grade ≥3 pulmonary complications. (Patients with previously resolved infectious pneumonia without current clinical significance may be eligible.)
  8. Pregnant or breastfeeding women.
  9. Patients with clinically significant cardiovascular disease within the past 12 months (e.g., congestive heart failure, symptomatic coronary artery disease, arrhythmias, myocardial infarction).
  10. Patients whose toxicities from prior anticancer therapy have not recovered to baseline or ≤ Grade 2.
  11. Patients who received any prior anticancer therapy within 14 days or localized radiotherapy within 7 days before the first dose of the study drug.
  12. Patients with a known hypersensitivity to the study drugs.
  13. Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

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: Randomized
  • Interventional Model: Parallel 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: Combination therapy of Lurbinectedin and Paclitaxel

The study drugs are administered every 3 weeks until disease progression or unacceptable drug-related toxicity.

Lurbinectedin is given IV at 2.2 mg/m² on Day 1, Paclitaxel IV at 80 mg/m² on Days 1 and 8, and Pegylated G-CSF on Day 2, about 24 hours after chemotherapy.
Drug: Lurbinectedin
Administered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity.
Drug: Paclitaxel
Administered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.
Active Comparator: Paclitaxel monotherapy
The study drugs are given every 3 weeks until disease progression or unacceptable drug-related toxicity. Paclitaxel is administered IV at 80 mg/m² on Days 1 and 8, and Pegylated G-CSF is given at the investigator's discretion.
Drug: Paclitaxel
Administered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.

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
Objective Response Rate (ORR)
Time Frame: End of trial(approximately 3years)

ORR is defined as the percentage of test subjects whose confirmed response was (RECIST 1.1) at least one full response (Complete Response, CR) or partial response (Partial Response, PR) before evidence of disease progression appears.

The objective response rate is summarized for groups that can be evaluated for validity. The objective response rate is presented with a 95% confidence interval on both sides (assuming a normal distribution).
End of trial(approximately 3years)

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
Progression-Free Survival (PFS) according to RECIST v1.1
Time Frame: End of trial (approximately 3 years)

PFS is defined as the period from the date of administration of the first clinical trial drug to the progression of the disease or death for any reason.

The progression-free survival period is analyzed for groups that can be evaluated for validity.
End of trial (approximately 3 years)
PFS2 for the Two Regimens (Progression-Free Survival 2)
Time Frame: End of trial (approximately 3 years)

Progression-Free Survival (PFS) is defined as the time from the first administration date of the investigational drug in the clinical trial to the date of the second disease progression (PD) during subsequent chemotherapy, death, or death from any cause, whichever occurs first. PFS will be analyzed using the Kaplan-Meier method. The secondary progression-free survival will be analyzed in the efficacy evaluable population.

If progression status cannot be assessed due to death during follow-up, end of survival confirmation, withdrawal of consent, or other reasons, the last disease assessment date will be censored.
End of trial (approximately 3 years)
Overall survival (OS)
Time Frame: End of trial (approximately 3 years)

Overall Survival (OS) is assessed based on the date of first administration of the investigational drug and the survival status at the time of analysis. OS is defined as the time from the first administration of the investigational drug to death from any cause.

OS will be analyzed in the safety analysis set and presented using Kaplan-Meier plots. The number of events, median survival time (calculated from Kaplan-Meier curves), and the proportion of subjects without events will be summarized at 6, 12, and 18 months. The numbers and proportions of subjects who have died, are alive, lost to follow-up, or withdrawn consent will also be appropriately summarized.
End of trial (approximately 3 years)
Disease control rate (DCR)
Time Frame: End of trial (approximately 3 years)

Disease Control Rate (DCR) is defined as the percentage of subjects whose best overall response (BOR), including both intracranial and extracranial responses, is complete response (CR), partial response (PR), responding, or stable disease (SD). DCR will be summarized in the efficacy evaluable population.

DCR will be presented along with two-sided 95% confidence intervals, assuming a normal distribution
End of trial (approximately 3 years)
Duration of response (DoR)
Time Frame: End of trial (approximately 3 years)

Duration of Response (DoR) is defined as the time from the date of first recorded confirmed response to the date of disease progression or death, whichever occurs first (the same as a PFS event). The start of response is defined as the most recent visit date at which a confirmed PR or CR was observed. For subjects who achieve a response but do not experience disease progression, DoR is calculated using the censoring time of PFS.

DoR will be analyzed in the subset of the efficacy evaluable population whose best overall response is a confirmed CR or PR. For subjects who respond to treatment, DoR will be summarized, and the number of subjects with DoR exceeding 3, 6, 9, and 12 months will be presented. Kaplan-Meier plots and median DoR (calculated from Kaplan-Meier curves) will also be presented.
End of trial (approximately 3 years)
Post-crossover progression-free survival (PFS)
Time Frame: End of trial (approximately 3 years)
Progression-free survival (PFS) will be evaluated in subjects who were randomized to the control arm (paclitaxel) and subsequently crossed over to receive at least one dose of lurbinectedin monotherapy after confirmed disease progression during paclitaxel treatment. PFS will be analyzed using the Kaplan-Meier method and presented with two-sided 95% confidence intervals. Prespecified subgroup analyses will be performed according to prior paclitaxel response status (CR/PR versus SD/PD) and prior PFS duration (≥3 months versus <3 months).
End of trial (approximately 3 years)
Post-crossover overall survival (OS)
Time Frame: End of trial (approximately 3 years)
Overall survival (OS) will be evaluated in subjects who were randomized to the control arm (paclitaxel) and subsequently crossed over to receive at least one dose of lurbinectedin monotherapy after confirmed disease progression during paclitaxel treatment. OS will be analyzed using the Kaplan-Meier method and presented with two-sided 95% confidence intervals. Prespecified subgroup analyses will be performed according to prior paclitaxel response status (CR/PR versus SD/PD) and prior PFS duration (≥3 months versus <3 months).
End of trial (approximately 3 years)
Number of participants with treatment-related adverse events
Time Frame: End of trial (approximately 3 years)
Treatment-related adverse events will be assessed in all subjects receiving at least one dose of study treatment and graded according to NCI CTCAE. The number and percentage of participants experiencing at least one treatment-related adverse event will be reported.
End of trial (approximately 3 years)

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.
Yonsei University

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: Hye Ryun Kim, Severance Hospital

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 (Estimated)

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.
June 1, 2026

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.
April 1, 2027

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.
February 1, 2029

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).
May 21, 2026

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.
June 5, 2026

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.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

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.
June 11, 2026

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.
June 5, 2026

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.
December 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.
  • 4-2025-1042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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