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

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: Recruiting
• Conditions: Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Small Cell Lung; Limited-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: Tarlatamab

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: Interventional
• Enrollment (Estimated): 37
• Phase: Phase 2

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	From date of enrollment until the date of last follow up, assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the date of enrollment to the date of last follow up, assessed up to 24 months
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	From the date of enrollment to 6 months, 1 and 2 years
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	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

• Sponsor: Fundación GECP
• Investigators: Study Chair: Mariano Provencio, MD, President of Grupo Español de Cáncer de Pulmón

Publications and helpful links

Helpful Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Maintenance treatment; Immunotherapy; Antineoplastic Agents; Non small cell lung cancer; Tarlatamab; Chemo-radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Thoracic Neoplasms; Respiratory Tract Neoplasms
• Other Study ID 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