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Limited-stage Small-cell Lung CancerPhase 2MERLINNCT07242547

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

A Phase 2 study testing Tarlatamab in people with Limited-stage Small-cell Lung Cancer and Carcinoma, Small Cell Lung, run by Fundación GECP at 20 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tarlatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
20 sitesSpain
Study dates
20 May 2026to 1 Jun 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • were treated with sequential chemo-radiotherapy
  • 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
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Pereira contact

+34934302006

gecp@gecp.org

20 sites in 1 country

Spain20 sites, 20 recruiting

  • Hospital General Universitario de Albacete

    Albacete, Albacete, 02006

    Blanca Riesco, MD

    Blanca Riesco, MD

    Recruiting

  • Hospital General Universitario Dr. Balmis de Alicante

    Alicante, Alicante, 03010

    Juan Luís Martí, MD

    Juan Luís Martí, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

    Andrés Barba, MD

    Andrés Barba, MD

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

    Pedro Rocha, MD

    Pedro Rocha, MD

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

    Laura Mezquita, MD

    Laura Mezquita, MD

    Recruiting

  • Hospital de Basurto

    Bilbao, Bizkaia, 48013

    María Ángeles Sala, MD

    María Ángeles Sala, MD

    Recruiting

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

    Javier David Benitez, MD

    Javier David Benitez, MD

    Recruiting

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

    Leo Tallafigo, MD

    Leo Tallafigo, MD

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

    Begoña Campos, MD

    Begoña Campos

    Recruiting

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

    Carlos Aguado, MD

    Carlos Aguado, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Manuel Dómine, MD

    Manuel Dómine, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Madrid, Madrid, 28222

    Mariano Provencio, MD

    Mariano Provencio, MD

    Recruiting

  • Hospital Regional de Málaga

    Málaga, Málaga, 29010

    Airam Padilla, MD

    Airam Padilla, MD

    Recruiting

  • Fundació Althaia

    Manresa, Barcelona, 08243

    Silvia Catot, MD

    Silvia Catot, MD

    Recruiting

  • Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense

    Ourense, Ourense, 32005

    Karmele Areses, MD

    Karmele Areses, MD

    Recruiting

  • Hospital Son Espases

    Palma de Mallorca, Mallorca, 07120

    Raquel Marsé, MD

    Raquel Marsé, MD

    Recruiting

  • Hospital Son Llàtzer

    Palma de Mallorca, Mallorca, 07198

    Juan Coves, MD

    Juan Coves, MD

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

    Maite Martínez, MD

    Maite Martínez, MD

    Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010

    Karla Medina, MD

    Karla Medina, MD

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

    Paula Espinosa, MD

    Paula Espinosa, MD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Tarlatamab
Keywords
Non small cell lung cancer, Tarlatamab, Maintenance treatment, Antineoplastic Agents, Chemo-radiotherapy, Immunotherapy
Medical subject headings
Small Cell Lung Carcinoma, Respiratory Tract Neoplasms, Thoracic Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarlatamabDrug

    Also called Imdelltra

    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.

Study groups in NCT07242547
Study groupRoleWhat they receive
Experimental: Maintenance treatmentExperimentalPatients 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.
Receives: Drug: Tarlatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    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.

    Measured: From date of enrollment until the date of last follow up, assessed up to 24 months.

Secondary outcomes (3)

  1. Objective response rate (ORR)

    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.

    Measured: From the date of enrollment to the date of last follow up, assessed up to 24 months

  2. Overall Survival (OS)

    OS at 6 months and 1 and 2 years, defined as the time from enrollment to the date of death from any cause

    Measured: From the date of enrollment to 6 months, 1 and 2 years

  3. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

    Measured: From the subject's written consent to participate in the study through 90 days after the final administration of the drug.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start20 May 2026
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07242547
Sponsor's protocol ID
GECP 24/01_MERLIN
Other IDs
2024-515201-26-00
Acronym
MERLIN
Status last verified
Jul 2026
First submitted
17 Nov 2025
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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