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

NCT07242547 | Recruiting Phase 2 DMC

• 2 other identifiers: GECP 24/01_MERLIN2024-515201-26-00
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Keywords

Non small cell lung cancer; Tarlatamab; Maintenance treatment; Antineoplastic Agents; Chemo-radiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Objective response rate (ORR)

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

• Overall Survival (OS)

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

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

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

Study Arms (1)

Experimental: Maintenance treatment

EXPERIMENTAL

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

Interventions

Tarlatamab 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.

Also known as: Imdelltra

Experimental: Maintenance treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (20)

Hospital General Universitario de Albacete

Albacete, Albacete, 02006, Spain

NOT YET RECRUITING

Hospital General Universitario Dr. Balmis de Alicante

Alicante, Alicante, 03010, Spain

NOT YET RECRUITING

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

NOT YET RECRUITING

Fundació Althaia

Manresa, Barcelona, 08243, Spain

NOT YET RECRUITING

Hospital de Basurto

Bilbao, Bizkaia, 48013, Spain

NOT YET RECRUITING

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

NOT YET RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

NOT YET RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, Madrid, 28222, Spain

NOT YET RECRUITING

Hospital Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

NOT YET RECRUITING

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, 07198, Spain

NOT YET RECRUITING

Hospital Regional de Málaga

Málaga, Málaga, 29010, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense

Ourense, Ourense, 32005, Spain

NOT YET RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

NOT YET RECRUITING

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mariano Provencio, MD

  President of Grupo Español de Cáncer de Pulmón

  STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

+34934302006; gecp@gecp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: May 28, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (20)