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New drug combo aims to keep lung cancer in check longer

NCT ID NCT07459634

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This Phase 2 trial tests whether combining lurbinectedin (Zepzelca) with durvalumab (Imfinzi) as maintenance therapy can delay cancer growth in people with extensive-stage small-cell lung cancer whose disease has not worsened after initial chemotherapy plus durvalumab. About 50 participants will receive the two drugs intravenously. The main goal is to see how many patients remain progression-free after a set time.

What this could mean

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

Active substance
lurbinectedin (Zepzelca) and durvalumab (Imfinzi)
What this could lead to
If successful, this combination could offer a new maintenance option to delay cancer progression in patients with extensive-stage small-cell lung cancer.
What could go wrong
This is an early Phase 2 trial with only 50 participants and no control group, so results may not confirm benefit. Side effects from the drug combination are possible.

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 50 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

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system). 2. Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab 3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician. 5. Adequate hematologic and end-organ function for at least 7 days prior to dosing. 6. Has a body weight \> 30 kg. 7. Adequate contraceptive precautions. Exclusion Criteria: 1. Clinically confirmed leptomeningeal carcinomatosis. 2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures 3. Significant cardiovascular disease within 3 months prior to enrollment 4. History of another primary malignancy 5. Presence or history of Central Nervous System (CNS) metastases 6. History of allogeneic organ transplantation. 7. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan. 8. Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment. 9. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. 10. Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

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

Extensive-stage small-cell lung cancer

How to take part

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

  1. The places running it

    5 sites. 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

  • Baptist Health

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Cancer Specialists of North Florida

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Carolina Blood and Cancer Care

    RECRUITING

    Rock Hill, South Carolina, 29732, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Valkyrie Clinical Trials, Inc.

    RECRUITING

    Los Angeles, California, 90067, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.