Experimental lung cancer combo trial halted early

NCT ID NCT05815160

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested an experimental drug called Debio 0123 combined with standard chemotherapy (carboplatin and etoposide) in 34 adults with small cell lung cancer that had returned after prior treatment. The main goal was to find a safe dose and check for side effects. The study was terminated, so full results are not available.

What this could mean

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

Active substance
Debio 0123 (an experimental drug) combined with carboplatin and etoposide (standard chemotherapy)
What this could lead to
If it works, this could point toward a new treatment option for people with small cell lung cancer that has come back after standard therapy.
What could go wrong
This is a very early (Phase 1) trial that was terminated, so results are limited. The combination may not prove safe or effective in larger studies.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

May 2023

Finished

Mar 2026

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. Histologically or cytologically confirmed SCLC 2. Tumor that is not bleeding 3. Prior platinum-based chemotherapy (carboplatin and/or cisplatin) * Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days since the last dose of prior standard platinum-based therapy * Part 2 (expansion): Recurrence or progression after a minimum of 90 days since the last dose of prior standard platinum-based therapy 4. Measurable disease per RECIST 1.1 5. Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available 6. ECOG performance status of 0-1 7. Life expectancy of at least 3 months in the best judgment of the Investigator 8. Adequate bone marrow, hepatic and renal function, adequate coagulation status 9. Willingness and ability to comply with scheduled visits, study treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Use of an investigational agent or medical device within 28 days prior to first dose of study treatment. 2. History of other malignancies requiring active treatment in the last 2 years prior to first dose of study treatment, except for superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent. 3. History of myocardial infarction or stroke in the last 6 months prior to first dose of study treatment, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, known family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy. 4. Left ventricular ejection fraction (LVEF) below 55%. 5. QTcF \>450 ms, history of congenital long QT syndrome, or clinically significant conduction abnormality, or any conduction abnormality that may increase the risk of TdP. 6. Clinically significant gastrointestinal abnormality that could affect the absorption of orally administered drugs 7. Major surgery ≤4 weeks prior to first dose of study treatment or incomplete recovery from the surgical procedure at the time of the first dose of study treatment. 8. Radiographic findings showing tumor involvement with large blood vessels or poor demarcation from them with increased risk for bleeding. 9. Radiographic findings of Interstitial lung disease (ILD) that are considered clinically significant. 10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 11. Any infection requiring the systemic use of an antibiotic or antiviral agent. 12. Known Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency Virus (HIV) infection. Participants with past infections that have been cured may be enrolled. 13. Immunization with live or live-attenuated vaccine within 28 days prior to first dose of study treatment. 14. Inability or unwillingness to swallow oral medications. 15. Anticancer treatment (including chemotherapy), monoclonal antibodies/biologics, or radiotherapy with curative intent within 28 days prior to first dose of study treatment. Palliative radiation is allowed up to 1 week prior to study treatment start. 16. Unresolved AEs or toxicities due to previous treatments \>Grade 1. Note: Participants with ≤Grade 2 alopecia or endocrinopathies controlled by replacement therapy are exceptions and may qualify for the study. 17. Hypersensitivity to Debio 0123, etoposide or carboplatin, or any of the excipients found in the formulations for Debio 0123, etoposide, or carboplatin. If a prior hypersensitivity to carboplatin has been observed but a successful desensitization was performed for the participant, he or she may be eligible for the study. 18. Prior exposure to any WEE1 inhibitor Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

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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.

Contacts and locations

Locations

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Quironsalud Malaga

    Málaga, 29004, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro. START Madrid - Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de A Coruna

    A Coruña, 15006, Spain

  • Institut Catala D'Oncologia - Badalona

    Barcelona, 08908, Spain

  • NEXT Oncology Madrid

    Madrid, 28223, Spain

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States