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.
Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible.
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.
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.
Fundación GECP
Lead sponsor