TARLATAMAB for Small cell lung cancer|Extensive-stage small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Written informed consent obtained from the subject prior to performing any protocol-related procedures.\n- Age ≥ 18 years\n- ECOG performance status 2\n- Histologically confirmed small-cell lung cancer (initial mixed histology / combined SCLC permitted if re-biopsy of current progression shows SCLC)\n- Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded\n- Has received at least one prior line of treatment in the recurrent or metastatic setting\n- Has received a prior treatment line with platinum, etoposide, and a PD-L1 antibody. Treatment with chemotherapy only is acceptable if the patient had a contraindication for CPI treatment\n- Measurable disease according to RECIST v1.1"}

Exclusion criteria

• {"criterion_text":"- ECOG performance status 0, 1, 3 or 4\n- Respiratory compromise leading to an unjustifiable risk in case of higher-grade CRS, in the judgment of the investigator (possible criteria leading to such judgment: oxygen support at rest >2l/min, active pneumonia or pneumonitis)\n- Prior DLL3-directed treatment\n- Prior systemic therapy (chemotherapy, CPI) within 14 days prior to first dose of study treatment\n- Previous treatment in the present study (does not include screening failure)\n- History of immune-mediated encephalitis\n- Concurrent malignancy other than SCLC requiring active treatment\n- HIV infection not on stable antiviral treatment\n- Women of childbearing potential or men with partners of childbearing potential who are not adhering to contraceptive measures\n- Female subjects of childbearing potential a.\tunwilling to use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 60 days after the last dose of tarlatamab b.\twho are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab c.\tplanning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab d.\twith a positive pregnancy test at screening\n- Male subjects a.\twith 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 tarlatamab b.\twith 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 tarlatamab c.\tunwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab\n- Life expectancy less than one month\n- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG]\n- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG]\n- Active brain metastases with unstable symptoms (new or progressive neurological symptoms within the last 3 weeks)\n- Bone marrow insufficiency: a.\tneutrophil count < 1.5/nl or b.\themoglobin <8 mg/dl or c.\tplatelets <100/nl\n- Advanced liver disease: a.\tSubjects with pre-existing chronic liver disease: i.\tTotal bilirubin > 1.5xULN or ii.\tALT or AST > 3xULN b.\tSubjects with no relevant prior chronic liver disease and elevated liver parameters due to liver metastases: i.\tTotal bilirubin > 3xULN or ii.\tALT or AST > 10xULN c.\tInternational normalized ratio (INR) > 2.0 and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≥ 1.5 x ULN, except for subjects undergoing new class anticoagulant therapy (eg, Apixaban, Rivaroxaban, Edoxaban) with stable dose for 2 weeks prior to enrollment\n- Advanced kidney disease: CKD-EPI GFR <20 ml/min/1.73m²\n- Heart failure with reduced ejection fraction (EF < 40%)\n- Hemodynamically significant pericardial effusion\n- Clinically significant pleural effusion (Clinically significant pleural effusions must be managed by drainage. Re-check within 3 days prior to initiation of treatment)"}

Primary endpoints

• {"endpoint_text":"- Overall survival (OS) rate at 12 months","definition_or_measurement_approach":"Overall survival (OS) rate measured at 12 months"}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Objective response rate (ORR) (RECIST v1.1)","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
• {"endpoint_text":"- intracranial ORR (RECIST v1.1)","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
• {"endpoint_text":"- Rate of patients tolerating tarlatamab until first disease assessment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to next-line systemic therapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Safety and tolerability","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life: o\tEORTC-QLQ-C30 o\tPRO CTCAE","definition_or_measurement_approach":"Quality of life assessed using EORTC-QLQ-C30 and PRO-CTCAE"}

Germany

Earliest CTIS Part Ii Submission Date

23-10-2025

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

172

Number Of Sites

11

Number Of Participants

57

Primary sponsor

Full Name

AIO-Studien gGmbH

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"AMGEN","duties_or_roles":"Source of monetary support","organisation_type":""}