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New hope for lung cancer patients: maintenance drug aims to keep disease at bay

NCT ID NCT07242547

Disease control Sponsor: Fundación GECP 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests a drug called tarlatamab as a maintenance treatment for people with limited-stage small cell lung cancer who cannot receive standard combined chemotherapy and radiation. After completing chemotherapy with or without radiation, participants who have not gotten worse will receive tarlatamab intravenously until their disease progresses or side effects become unacceptable. The main goal is to see how long the drug can delay cancer growth or death.

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 37 people

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

Started

May 2026

Expected to finish

Jun 2030

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

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: * Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible. * Patients who: 1. were treated with sequential chemo-radiotherapy 2. were treated only with chemotherapy * Have at least one lesion that meets criteria for being measurable or non-measurable, as defined by RECIST 1.1. * Has completed chemo-radiation or chemotherapy alone without progression of disease per RECIST v1.1 * Be male or female ≥18 years of age inclusive, on the day of signing informed consent. * Have a life expectancy of at least 3 months from the study start. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention. * Toxicities attributed to chemo-radiotherapy treatment have to be resolved to grade ≤1, unless otherwise specified. * No clinically significant electrocardiogram (ECG) findings * Correct pulmonary function without oxygen supplementation * Have voluntarily agreed to participate by giving written consent for the study prior to any specific protocol procedures. * Have adequate organ function (hematological and biochemistry parameters). Exclusion Criteria: * Patients expected to require any other form of radiation therapy for LS-SCLC as concurrent radiotherapy. * Extensive-stage SCLC (ES-SCLC) or any previous diagnosis of transformed non-small cell lung cancer. Mixed tumors (SCLC-NSCLC) are not eligible. * Has known history of, or active, neurologic paraneoplastic syndrome of autoimmune nature. * Has had major surgery within 4 weeks prior to first dose of study interventions. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. * Has known history of a second malignancy other than SCLC, unless potentially curative treatment has been completed with no evidence of malignancy for at least 3 years since the initiation of that therapy. * Uncontrolled intercurrent active infection at the time of enrollment requiring systemic therapy. * Evidence of interstitial lung disease or active, non-infectious pneumonitis. * History of solid organ transplantation. * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \>class II) within 6 months prior to first dose of study treatment. * Has a known history of Human Immunodeficiency Virus (HIV) infection. * Has a known history of Hepatitis B or known active Hepatitis C virus infection. * Has a known history of active tuberculosis. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention. * Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment. * Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment. * Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment. * Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test. * Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment. * Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment. * Subject has known sensitivity to any of the products or components to be administered during dosing.

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Conditions

The condition(s) this trial relates to.

neoplasm of thorax non-small cell lung carcinoma respiratory tract neoplasm small cell lung carcinoma Thoracic Neoplasms

As listed by the trial registrant

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

Carcinoma, small cell lung Limited stage small cell lung cancer Respiratory tract neoplasms Thoracic neoplasms

How to take part

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

  1. The places running it

    20 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

  • Complejo Hospitalario de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Fundació Althaia

    RECRUITING

    Manresa, Barcelona, 08243, Spain

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital General Universitario Dr. Balmis de Alicante

    RECRUITING

    Alicante, Alicante, 03010, Spain

  • Hospital General Universitario de Albacete

    RECRUITING

    Albacete, Albacete, 02006, Spain

  • Hospital General Universitario de Elche

    RECRUITING

    Elche, Alicante, 03203, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46014, Spain

  • Hospital Regional de Málaga

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense

    RECRUITING

    Ourense, Ourense, 32005, Spain

  • Hospital Son Espases

    RECRUITING

    Palma de Mallorca, Mallorca, 07120, Spain

  • Hospital Son Llàtzer

    RECRUITING

    Palma de Mallorca, Mallorca, 07198, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Lugo, 27003, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    RECRUITING

    Santa Cruz de Tenerife, Tenerife, 38010, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Madrid, Madrid, 28222, Spain

  • Hospital Universitario de Jerez de la Frontera

    RECRUITING

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital de Basurto

    RECRUITING

    Bilbao, Bizkaia, 48013, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Barcelona, 08025, Spain

More trials for these conditions

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