Carcinoma, Small Cell LungPhase 2LUPINENCT07640932
Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer
A Phase 2 study testing Lurbinectedin and Paclitaxel in people with Carcinoma, Small Cell Lung, run by Yonsei University at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Small Cell Lung
- What is being tested?
- Lurbinectedin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2026to Feb 2029
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- 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).
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- At least one measurable target lesion according to RECIST v1.1 criteria.
- Predicted life expectancy of at least 12 weeks (3 months).
- 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
- Willingness to provide unstained slides (minimum 5, ideally 15) from archived or freshly biopsied tissue for exploratory analyses.
- 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.
- Male participants of reproductive potential must agree to use effective contraception during the study (see appendix for acceptable methods).
- Voluntary written informed consent to participate in this clinical trial.
Who cannot join
- Patients who have not received prior systemic therapy for small cell lung cancer (SCLC).
- Patients previously treated with Lurbinectedin or Paclitaxel.
- Patients with limited-stage small cell lung cancer (LS-SCLC).
- 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).
- 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.
- Patients with active primary immunodeficiency (e.g., HIV infection), active hepatitis B, or active hepatitis C:
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- 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.
- 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.)
- Pregnant or breastfeeding women.
- Patients with clinically significant cardiovascular disease within the past 12 months (e.g., congestive heart failure, symptomatic coronary artery disease, arrhythmias, myocardial infarction).
- Patients whose toxicities from prior anticancer therapy have not recovered to baseline or ≤ Grade 2.
- Patients who received any prior anticancer therapy within 14 days or localized radiotherapy within 7 days before the first dose of the study drug.
- Patients with a known hypersensitivity to the study drugs.
- Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Hye Ryun Kim, 82-2-2228-8125, nobelg@yuhs.ac
inspector@yuhs.ac
About this study
Official title: 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.
- Conditions
- Carcinoma, Small Cell Lung
- Being tested
- Lurbinectedin, Paclitaxel
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurbinectedinDrug
Administered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity.
PaclitaxelDrug
Administered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy of Lurbinectedin and Paclitaxel | Experimental | 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. Receives: Drug: Lurbinectedin; Drug: Paclitaxel |
| Paclitaxel monotherapy | Active comparator | 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. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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).
Measured: End of trial(approximately 3years)
Secondary outcomes (8)
Progression-Free Survival (PFS) according to RECIST v1.1
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.
Measured: End of trial (approximately 3 years)
PFS2 for the Two Regimens (Progression-Free Survival 2)
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.
Measured: End of trial (approximately 3 years)
Overall survival (OS)
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.
Measured: End of trial (approximately 3 years)
Disease control rate (DCR)
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
Measured: End of trial (approximately 3 years)
Duration of response (DoR)
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.
Measured: End of trial (approximately 3 years)
Post-crossover progression-free survival (PFS)
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).
Measured: End of trial (approximately 3 years)
Post-crossover overall survival (OS)
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).
Measured: End of trial (approximately 3 years)
Number of participants with treatment-related adverse events
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.
Measured: End of trial (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small Cell LungStudies of the same condition, open and under way.
- More trials run by Yonsei 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gon Kim, Yonsei University
- Investigators
- Hye Ryun Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640932
- Sponsor's protocol ID
- 4-2025-1042
- Acronym
- LUPINE
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07640932
- Acronym / sponsor ID
- LUPINE / 4-2025-1042
- Conditions
- Carcinoma, Small Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 11 Jun 2026 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy of Lurbinectedin and Paclitaxel | Experimental | Drug: Lurbinectedin, Drug: PaclitaxelThe 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. |
| Paclitaxel monotherapy | Active comparator | Drug: PaclitaxelThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 19 years.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- 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:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- At least one measurable target lesion according to RECIST v1.1 criteria.
Key exclusion criteria (15 listed)
- Patients who have not received prior systemic therapy for small cell lung cancer (SCLC).
- Patients previously treated with Lurbinectedin or Paclitaxel.
- Patients with limited-stage small cell lung cancer (LS-SCLC).
- 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).
- 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.
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 |
|---|---|---|
| LurbinectedinAdministered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity. | Drug | Combination therapy of Lurbinectedin and Paclitaxel |
| PaclitaxelAdministered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity. | Drug | Combination therapy of Lurbinectedin and Paclitaxel, Paclitaxel monotherapy |
Primary outcome
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).
8 secondary outcomes
Progression-Free Survival (PFS) according to RECIST v1.1
Time frame: End of trial (approximately 3 years)
PFS2 for the Two Regimens (Progression-Free Survival 2)
Time frame: End of trial (approximately 3 years)
Overall survival (OS)
Time frame: End of trial (approximately 3 years)
Disease control rate (DCR)
Time frame: End of trial (approximately 3 years)
Duration of response (DoR)
Time frame: End of trial (approximately 3 years)
Post-crossover progression-free survival (PFS)
Time frame: End of trial (approximately 3 years)
Post-crossover overall survival (OS)
Time frame: End of trial (approximately 3 years)
Number of participants with treatment-related adverse events
Time frame: End of trial (approximately 3 years)
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hye Ryun Kim principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lurbinectedin and Paclitaxel in people with Carcinoma, Small Cell Lung, run by Yonsei University at 1 site in South Korea.
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 15 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hye Ryun KIM (82-2-2228-8125, nobelg@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: End of trial(approximately 3years)). 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 4 Sep 2026.