TARLATAMAB for Small cell lung cancer | Small cell lung cancer limited stage

Inclusion criteria

• {"criterion_text":"- 1. Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible."}
• {"criterion_text":"- 10. Correct pulmonary function without oxygen supplementation"}
• {"criterion_text":"- 11. Have voluntarily agreed to participate by giving written consent for the study prior to any specific protocol procedures."}
• {"criterion_text":"- 12.  Have adequate organ function (hematological and biochemistry parameters) •\tabsolute neutrophil count ³ 1.5 x 109/L •\tplatelet count ³ 100 x 109/L •\themoglobin > 9 g/dL (90 g/L) •\tProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) 1.5 x institutional upper limit of normal (ULN) except for subjects on anticoagulation •\tEstimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min •\tAspartate aminotransferase (AST) and alanine aminotransferase (ALT)<3 X ULN (or < 5 x ULN for subjects with liver involvement) •\tTotal bilirubin (TBL) < 1.5 X ULN (or < 2 x ULN for subjects with liver involvement) •\tPulmonary function: No clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (eg, PleurX) are allowed •\tBaseline oxygen saturation > 90% on room air •\tCardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings. \""}
• {"criterion_text":"- 2. Patients who: a. were treated with sequential chemo-radiotherapy b.were treated only with chemotherapy"}
• {"criterion_text":"- 3. Have at least one lesion that meets criteria for being measurable or non-measurable, as defined by RECIST 1.1."}
• {"criterion_text":"- 4. Has completed chemo-radiation or chemotherapy alone without progression of disease per RECIST v1.1"}
• {"criterion_text":"- 5. Be male or female ≥18 years of age inclusive, on the day of signing informed consent."}
• {"criterion_text":"- 6. Have a life expectancy of at least 3 months from the study start."}
• {"criterion_text":"- 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention"}
• {"criterion_text":"- 8. Toxicities attributed to chemo-radiotherapy treatment have to be resolved to grade ≤1, unless otherwise specified (alopecia is excluded)."}
• {"criterion_text":"- 9. No clinically significant electrocardiogram (ECG) findings"}

Exclusion criteria

• {"criterion_text":"- 1. Patients expected to require any other form of radiation therapy for LS-SCLC as concurrent radiotherapy (concurrent radiation defined as radiotherapy started during the first or second cycle of chemotherapy)"}
• {"criterion_text":"- 10. Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association >class II) within 6 months prior to first dose of study treatment"}
• {"criterion_text":"- 11. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: HIV testing is not required unless mandated by the local health authority.\""}
• {"criterion_text":"- 12. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection (defined as HCV RNA [qualitative] or HCV antibody reactive [HCV Ab], if HCV-RNA is not the local SOC)."}
• {"criterion_text":"- 13.\tHas a known history of active tuberculosis."}
• {"criterion_text":"- 14. 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."}
• {"criterion_text":"- 15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial."}
• {"criterion_text":"- 16. Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention."}
• {"criterion_text":"- 17. 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."}
• {"criterion_text":"- 18. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment."}
• {"criterion_text":"- 19. Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment."}
• {"criterion_text":"- 2. Extensive-stage SCLC (ES-SCLC) or any previous diagnosis of transformed non-small cell lung cancer. Mixed tumors (SCLC-NSCLC) are not eligible."}
• {"criterion_text":"- 20. Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test."}
• {"criterion_text":"- 21. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of study treatment."}
• {"criterion_text":"- 22. 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."}
• {"criterion_text":"- 23. Subject has known sensitivity to any of the products or components to be administered during dosing."}
• {"criterion_text":"- 3. Has known history of, or active, neurologic paraneoplastic syndrome of autoimmune nature."}
• {"criterion_text":"- 4. Has had major surgery within 4 weeks prior to first dose of study interventions."}
• {"criterion_text":"- 5. 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."}
• {"criterion_text":"- 6. 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."}
• {"criterion_text":"- 7. Uncontrolled intercurrent active infection at the time of enrollment requiring systemic therapy."}
• {"criterion_text":"- 8. Evidence of interstitial lung disease or active, non-infectious pneumonitis"}
• {"criterion_text":"- 9. History of solid organ transplantation"}

Primary endpoints

• {"endpoint_text":"- Efficacy of Tarlatamab as maintenance treatment assessed by 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","definition_or_measurement_approach":"PFS defined as time from enrollment to first documentation of disease progression according to RECIST 1.1 or death from any cause, whichever is earlier; assessed per RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- 1. 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 RECIST 1.1.","definition_or_measurement_approach":"Investigator-assessed ORR defined as confirmed CR plus PR per RECIST 1.1."}
• {"endpoint_text":"- 2. OS at 6 months and 1 and 2 years, defined as the time from enrollment to the date of death from any cause","definition_or_measurement_approach":"Overall survival (OS) measured from enrollment to date of death from any cause; reported at 6 months, 1 year and 2 years."}
• {"endpoint_text":"- 3. PFS at 6 months and 1 and 2 years, defined as the time from enrollment to the date of death from any cause","definition_or_measurement_approach":"Progression-free survival (PFS) measured and reported at 6 months, 1 year and 2 years; defined per RECIST 1.1 or death."}
• {"endpoint_text":"- 4. Evaluate the safety and tolerability of Tarlatamab as maintenance treatment.","definition_or_measurement_approach":"Safety and tolerability evaluated through adverse event reporting, clinical and laboratory assessments."}
• {"endpoint_text":"- 5. Incidence of adverse events (AEs) describing their frequency and severity, study intervention discontinuations due to AEs and the grade of relationship with the study drugs according to CTCAE v5.0","definition_or_measurement_approach":"AEs graded per CTCAE v5.0; incidence, severity, discontinuations and relationship to study drug will be recorded and reported."}
• {"endpoint_text":"- 6. To study the tumour microenvironment at baseline and the antitumor immune response in peripheral blood throughout treatment and correlate the results to clinical outcomes, ORR, OS, and AEs.","definition_or_measurement_approach":"Correlative translational analyses of tumour microenvironment at baseline and peripheral blood immune response during treatment correlated with clinical outcomes (ORR, OS, AEs)."}

Spain

Earliest CTIS Part Ii Submission Date

02-09-2025

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

217

Number Of Sites

20

Number Of Participants

37

Primary sponsor

Full Name

Fundacion GECP

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain