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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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.
Hospital General Universitario de Albacete
Albacete, Albacete, Spain
RECRUITINGHospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain
RECRUITINGHospital General Universitario de Elche
Elche, Alicante, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital Clínic de Barcelona
Barcelona, Barcelona, Spain
RECRUITINGFundació Althaia
Manresa, Barcelona, Spain
RECRUITINGHospital de Basurto
Bilbao, Bizkaia, Spain
RECRUITINGHospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
RECRUITINGHospital Universitario Lucus Augusti
Lugo, Lugo, Spain
RECRUITING...and 10 more locations
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.
Time frame: From date of enrollment until the date of last follow up, assessed up to 24 months.
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.
Time frame: 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
Time frame: 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.
Time frame: From the subject's written consent to participate in the study through 90 days after the final administration of the drug.
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