Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients (MERLIN)

April 29, 2026 updated by: Fundación GECP

A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy

This is an open-label, phase II, exploratory and multi-centre clinical trial. 37 Limited stage SCLC patients not eligible for concurrent chemo-radiotherapy will be enroll.

Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will be treated with maintenance Tarlatamab.

Patients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death.

The primary objective is to evaluate the Progression free survival (PFS).

Patient accrual is expected to be completed within 2 years. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 2 years after enrollment. The study will end once survival follow-up has concluded.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study MERLIN is a phase II clinical trial intending to enroll 37 patients, who will receive will receive Tarlatamab as maintenance treatment.

This is an open-label, phase II, exploratory and multi-centre clinical trial. Limited stage SCLC patients not eligible for concurrent chemo-radiotherapy will be selected.

Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will be treated with maintenance Tarlatamab.

Patients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death.

For all patients, tumor response data collection will continue until disease progression, even if the patient stops study treatment prior to disease progression.

Patients who still benefit from the drug treatment at the end of the study or at early termination of the clinical trial, will continue receiving the drug until progression disease.

The primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population. Progression free survival (PFS) defined as the time from enrollment to the date of the first documentation of disease progression according to RECIST 1.1 or death from any cause, whichever is earlier

Patient accrual is expected to be completed within 2 years. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 2 years after enrollment. The study will end once survival follow-up has concluded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eva Pereira
  • Phone Number: +34934302006
  • Email: gecp@gecp.org

Study Locations

  • Spain
    • Albacete
      • Albacete, Albacete, Spain, 02006
        • Not yet recruiting
        • Hospital General Universitario de Albacete
        • Contact:
          • Blanca Riesco, MD
        • Principal Investigator:
          • Blanca Riesco, MD
    • Alicante
      • Alicante, Alicante, Spain, 03010
        • Not yet recruiting
        • Hospital General Universitario Dr. Balmis de Alicante
        • Contact:
          • Juan Luís Martí, MD
        • Principal Investigator:
          • Juan Luís Martí, MD
      • Elche, Alicante, Spain, 03203
        • Not yet recruiting
        • Hospital General Universitario de Elche
        • Contact:
          • Javier David Benitez, MD
        • Principal Investigator:
          • Javier David Benitez, MD
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Pedro Rocha, MD
        • Principal Investigator:
          • Pedro Rocha, MD
      • Barcelona, Barcelona, Spain, 08025
        • Not yet recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
          • Andres Barba, MD
        • Principal Investigator:
          • Andres Barba, MD
      • Barcelona, Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clinic De Barcelona
        • Principal Investigator:
          • Laura Mezquita, MD
        • Contact:
          • Laura Mezquita, MD
      • Manresa, Barcelona, Spain, 08243
        • Not yet recruiting
        • Fundació Althaïa
        • Contact:
          • Silvia Catot, MD
        • Principal Investigator:
          • Silvia Catot, MD
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • Not yet recruiting
        • Hospital de Basurto
        • Contact:
          • María Ángeles Sala, MD
        • Principal Investigator:
          • María Ángeles Sala, MD
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Not yet recruiting
        • Hospital Universitario de Jerez de La Frontera
        • Contact:
          • Leo Tallafigo, MD
        • Principal Investigator:
          • Leo Tallafigo, MD
    • Lugo
      • Lugo, Lugo, Spain, 27003
        • Not yet recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Begoña Campos, MD
        • Principal Investigator:
          • Begoña Campos
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Principal Investigator:
          • Manuel Dómine, MD
        • Contact:
          • Manuel Dómine, MD
      • Madrid, Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
          • Mariano Provencio, MD
        • Principal Investigator:
          • Mariano Provencio, MD
      • Madrid, Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Carlos Aguado, MD
        • Principal Investigator:
          • Carlos Aguado, MD
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07120
        • Not yet recruiting
        • Hospital Son Espases
        • Contact:
          • Raquel Marsé, MD
        • Principal Investigator:
          • Raquel Marsé, MD
      • Palma de Mallorca, Mallorca, Spain, 07198
        • Not yet recruiting
        • Hospital Son Llatzer
        • Principal Investigator:
          • Juan Coves, MD
        • Contact:
          • Juan Coves, MD
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional de Malaga
        • Contact:
          • Airam Padilla, MD
        • Principal Investigator:
          • Airam Padilla, MD
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Not yet recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Maite Martínez, MD
        • Principal Investigator:
          • Maite Martínez, MD
    • Ourense
      • Ourense, Ourense, Spain, 32005
        • Not yet recruiting
        • Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense
        • Contact:
          • Karmele Areses, MD
        • Principal Investigator:
          • Karmele Areses, MD
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Not yet recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contact:
          • Karla Medina, MD
        • Principal Investigator:
          • Karla Medina, MD
    • Valencia
      • Valencia, Valencia, Spain, 46014
        • Not yet recruiting
        • Hospital General Universitario de Valencia
        • Principal Investigator:
          • Paula Espinosa, MD
        • Contact:
          • Paula Espinosa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Maintenance treatment

Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will receive tarlatamab maintenance treatment.

Patients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death.
Drug: Tarlatamab

Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will receive tarlatamab maintenance treatment.

Patients will receive maintenance with tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death.

Patients who still benefit from the drug treatment at the end of the study or at early termination of the clinical trial, will continue receiving the drug until progression disease.

Other Names:
  • Imdelltra

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From date of enrollment until the date of last follow up, assessed up to 24 months.
Efficacy of Tarlatamab as maintenance treatment assessed by progression free survival Progression-free survival, defined as the time from enrollment to the date of the first documentation of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause, whichever is earlier. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From date of enrollment until the date of last follow up, assessed up to 24 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From the date of enrollment to the date of last follow up, assessed up to 24 months
ORR: Describe the efficacy of Tarlatamab as maintenance treatment as assessed by objective response rate (ORR) Investigator-assessed ORR, defined as a confirmed complete response (CR) plus partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). According to RECIST 1.1, a complete response is the disappearance of all target lesions, and a partial response is defined as at least a 30% decrease in the sum of the target lesions.
From the date of enrollment to the date of last follow up, assessed up to 24 months
Overall Survival (OS)
Time Frame: From the date of enrollment to 6 months, 1 and 2 years
OS at 6 months and 1 and 2 years, defined as the time from enrollment to the date of death from any cause
From the date of enrollment to 6 months, 1 and 2 years
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: From the subject's written consent to participate in the study through 90 days after the final administration of the drug.
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
From the subject's written consent to participate in the study through 90 days after the final administration of the drug.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación GECP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mariano Provencio, MD, President of Grupo Español de Cáncer de Pulmón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GECP 24/01_MERLIN
  • 2024-515201-26-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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