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

NCT ID: NCT07242547

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2030-06-01

Brief 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 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.

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.

Conditions

Limited-stage Small-cell Lung Cancer; Carcinoma, Small Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tarlatamab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Imdelltra

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación GECP

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariano Provencio, MD

Role: STUDY_CHAIR

President of Grupo Español de Cáncer de Pulmón

Locations

Hospital General Universitario de Albacete

Albacete, Albacete, Spain

Hospital General Universitario Dr. Balmis de Alicante

Alicante, Alicante, Spain

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Fundació Althaia

Manresa, Barcelona, Spain

Hospital de Basurto

Bilbao, Bizkaia, Spain

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, Spain

Hospital Regional de Málaga

Málaga, Málaga, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense

Ourense, Ourense, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Countries

Spain

Central Contacts

Eva Pereira

Role: CONTACT

gecp@gecp.org

+34934302006

Facility Contacts

Blanca Riesco, MD

Role: primary

Juan Luís Martí, MD

Role: primary

Javier David Benitez, MD

Role: primary

Andrés Barba, MD

Role: primary

Pedro Rocha, MD

Role: primary

Laura Mezquita, MD

Role: primary

Silvia Catot, MD

Role: primary

María Ángeles Sala, MD

Role: primary

Leo Tallafigo, MD

Role: primary

Begoña Campos, MD

Role: primary

Carlos Aguado, MD

Role: primary

Manuel Dómine, MD

Role: primary

Mariano Provencio, MD

Role: primary

Raquel Marsé, MD

Role: primary

Juan Coves, MD

Role: primary

Airam Padilla, MD

Role: primary

Maite Martínez, MD

Role: primary

Karmele Areses, MD

Role: primary

Karla Medina, MD

Role: primary

Paula Espinosa, MD

Role: primary

Related Links

http://www.gecp.org

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

Other Identifiers

2024-515201-26-00

Identifier Type: CTIS

Identifier Source: secondary_id

GECP 24/01_MERLIN

Identifier Type: -

Identifier Source: org_study_id