ClinicalTrials.gg
Not yet recruitingNCT07640932LUPINEUpdated Sep 4, 2026

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

A Phase 2 interventional study of Lurbinectedin and Paclitaxel in Carcinoma, Small Cell Lung, sponsored by Yonsei University. Not yet recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Yonsei University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies testing PM 01183 in Small Cell Lung Carcinoma — 9 open to participants now, 11 under way, 3 of them phase 3. PM 01183 · Small Cell Lung Carcinoma.

Planned enrollment
8th of 16
69 · median 69
Started
2026
with 1 other
Phase 2
6 of 16
5 open now
Primary completion
2027-04
later than 4 of 10 live
Registered
16th of 16
by date

Among the 16 studies testing PM 01183 in Small Cell Lung Carcinoma, this one is the 8th largest by planned enrollment, is one of 2 that started in 2026, is one of 6 in phase 2, reaches primary completion later than 4 of the 10 other live ones, and was the 16th registered.

Small Cell Lung Carcinoma

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.

This study's planned enrollment of 69 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Open to participants now

9 of the 16 studies testing PM 01183 in Small Cell Lung Carcinoma are open now, in 12 countries. Each count lists the studies.

All 9 open studies →

About PM 01183

PM 01183: first FDA approval 2020 (ZEPZELCA), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 264 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 67 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.

This study: 20 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies testing PM 01183 in Small Cell Lung Carcinoma, or all of them as a file.
02

Study 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 chemotherapy.

03

Conditions studied

  • Carcinoma, Small Cell Lung
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 19 years.
  2. 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 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. (ECOG) performance status of 0-2.
  5. At least one measurable target lesion according to v1.1 criteria.
  6. Predicted of at least 12 weeks (3 months).
  7. Adequate hematologic, renal, metabolic, and hepatic function within 14 days prior to enrollment, defined as:

    (ANC) ≥ 1,500/μL count ≥ 100,000/μL (Hb) ≥ 9.0 g/dL Serum creatinine ≤ 1.5 × (ULN) or calculated (cCr) ≥ 60 mL/min Total ≤ 1.0 × ULN and ALT ≤ 3.0 × ULN (regardless of liver ) PT and ≤ 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 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 during the study.

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

Exclusion criteria

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 (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 , potent 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., infection), active , or active :

    • 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 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 to the study drugs.
  13. Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (estimated)

Study arms

  • 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 · Drug: Paclitaxel

  • 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

Interventions

  • Administered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity.

  • Administered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: End of trial(approximately 3years)

Secondary outcomes

  1. 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.

    Time frame: End of trial (approximately 3 years)

  2. 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.

    Time frame: End of trial (approximately 3 years)

  3. 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.

    Time frame: End of trial (approximately 3 years)

  4. 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

    Time frame: End of trial (approximately 3 years)

  5. 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.

    Time frame: End of trial (approximately 3 years)

  6. 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).

    Time frame: End of trial (approximately 3 years)

  7. 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).

    Time frame: End of trial (approximately 3 years)

  8. 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.

    Time frame: End of trial (approximately 3 years)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.

Of 150 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 87. This study's planned 5 months is below that.

Counting every sponsor, half of 203 studies reached it within 47 months; a quarter within 29 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2026
First posted
Jun 11, 2026
StartEst.
Nov 2026
Primary completionEst.
Apr 2027
CompletionEst.
Feb 2029
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07640932
Lead sponsor
Yonsei University
Responsible party
Chang Gon Kim (Principal Investigator, Yonsei University) — Principal investigator
First posted
Jun 11, 2026
Start date
Nov 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Feb 2029 (estimated)
Last update
Sep 4, 2026

Study contacts

Hye Ryun KIM
Contact
nobelg@yuhs.ac
82-2-2228-8125
Chang Gon kim
Contact
inspector@yuhs.ac
82-10-9162-1729
Hye Ryun Kim
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: PM 01183

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