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New chemo combo shows promise for tough lung cancer

NCT ID NCT07640932

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether adding lurbinectedin to paclitaxel works better than paclitaxel alone for people with advanced small cell lung cancer that has returned after first treatment. About 69 adults will be randomly assigned to one of two groups. The study measures how many patients' tumors shrink and how long they live without the cancer growing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lurbinectedin and paclitaxel (chemotherapy drugs)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced small cell lung cancer whose disease has worsened after initial chemotherapy.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 69 participants, so results may not apply to everyone. The combination may cause more side effects than paclitaxel alone, and it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 69 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yonsei University Health System, Severance Hospital

    Seoul, South Korea

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