TARLATAMAB for Small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Subject has provided informed consent before initiation of any study-specific activities/procedures. Exception: Standard of care imaging and laboratory assessments performed prior to informed consent."}
• {"criterion_text":"- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent."}
• {"criterion_text":"- Histologically or cytologically confirmed SCLC with demonstrated progression or relapse."}
• {"criterion_text":"- Subject has progressed or recurred following 1 platinum-based regimen. In countries where standard of care first-line systemic treatment for ES disease includes platinum-containing chemotherapy in combination with PD-(L)1 inhibitor, it is required that subjects have failed PD-(L)-1 inhibitor as part of their first-line systemic treatment or are ineligible to receive PD-(L)1 inhibitor therapy."}
• {"criterion_text":"- Measurable disease at baseline per RECIST 1.1 within the 21-day screening period. - Screening scans performed as standard of care and prior to informed consent, may be used to confirm subject eligibility if completed within the 21-day screening period, provided that informed consent for the use of these scans is obtained prior to any transfer of data."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
• {"criterion_text":"- Minimum life expectancy of 12 weeks."}
• {"criterion_text":"- Adequate organ function, defined as follows: Refer to protocol section 5.1 for more details. - Hematological function: - Coagulation function: - Renal function: - Hepatic function: - Pulmonary function: -Cardiac function:"}

Exclusion criteria

• {"criterion_text":"- Any previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC"}
• {"criterion_text":"- History of solid organ transplantation."}
• {"criterion_text":"- Prior anticancer therapy within 30 days of enrollment (14 days for conventional chemotherapy"}
• {"criterion_text":"- Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for Monkeypox infection) within 3 days prior to first dose of study treatment"}
• {"criterion_text":"- Prior enrollment on a tarlatamab clinical trial OR prior therapy with any selective inhibitor of the DLL3 pathway."}
• {"criterion_text":"- Receiving other anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy. Subjects who are receiving adjuvant hormonal therapy for resected breast cancer may be eligible (refer also to exclusion related to history of other malignancies)."}
• {"criterion_text":"- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment (see protocol section 5.2 for exceptions)"}
• {"criterion_text":"- Female subjects of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test"}
• {"criterion_text":"- 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 & for an additional XX days after the last dose of tarlatamab"}
• {"criterion_text":"- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional XX days after the last dose of tarlatamab"}
• {"criterion_text":"- Male subjects unwilling to abstain from donating sperm during treatment & for an additional XX days after the last dose of tarlatamab"}
• {"criterion_text":"- History of other malignancy within the past 2 years (see protocol section 5.2 for exceptions)"}
• {"criterion_text":"- 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":"- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment"}
• {"criterion_text":"- Prior history of severe or life-threatening events from any immune-mediated therapy"}
• {"criterion_text":"- Major surgical procedures within 21 days prior to first dose of study treatment"}
• {"criterion_text":"- Presence or history of viral infection: Human immunodeficiency virus (HIV) infection, Active hepatitis B or C infection"}
• {"criterion_text":"- Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment"}
• {"criterion_text":"- Symptomatic central nervous system (CNS) metastases (see protocol section 5.2 for exceptions)"}
• {"criterion_text":"- Subject has known sensitivity to any of the products or components to be administered during dosing"}
• {"criterion_text":"- Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures and participation in observational research studies while participating in this study are excluded"}
• {"criterion_text":"- Evidence of interstitial lung disease or active, non-infectious pneumonitis."}
• {"criterion_text":"- Female subjects of childbearing potential unwilling to use protocol-specified method of contraception during treatment & for an additional XX days after the last dose of tarlatamab"}
• {"criterion_text":"- Female subjects who are breastfeeding or who plan to breastfeed while on study through XX days after the last dose of tarlatamab."}
• {"criterion_text":"- Female subjects planning to become pregnant or donate eggs while on study through XX days after the last dose of tarlatamab."}
• {"criterion_text":"- Diagnosis or evidence of leptomeningeal disease"}
• {"criterion_text":"- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study"}

Primary endpoints

• {"endpoint_text":"- Confirmed OR (CR + PR)","definition_or_measurement_approach":"Assessed as objective response rate (ORR) based on blinded independent central review (BICR) per RECIST 1.1."}
• {"endpoint_text":"- CR (Complete Response)","definition_or_measurement_approach":"Complete response assessed per RECIST 1.1 (as part of ORR) by BICR."}
• {"endpoint_text":"- PR (Partial Response)","definition_or_measurement_approach":"Partial response assessed per RECIST 1.1 (as part of ORR) by BICR."}

Secondary endpoints

• {"endpoint_text":"- serum concentrations of tarlatamab","definition_or_measurement_approach":"Pharmacokinetic assessment: measurement of serum concentrations of tarlatamab (PK)."}
• {"endpoint_text":"- DOR - Duration of confirmed response","definition_or_measurement_approach":"Duration from first confirmed response to progression or death; assessed per RECIST 1.1."}
• {"endpoint_text":"- DC -Disease control is defined as objective response or stable disease.","definition_or_measurement_approach":"Disease control defined as objective response (CR or PR) or stable disease assessed per RECIST 1.1."}
• {"endpoint_text":"- Duration of DC","definition_or_measurement_approach":"Time from disease control (CR/PR or stable disease) to progression or death."}
• {"endpoint_text":"- PFS-Progression-free survival","definition_or_measurement_approach":"Time from randomization to documented disease progression or death; assessed per RECIST 1.1."}
• {"endpoint_text":"- OR - Objective response is defined as best overall response of CR or PR.","definition_or_measurement_approach":"Best overall response per RECIST 1.1 (CR or PR), as assessed by BICR and investigator (where specified)."}
• {"endpoint_text":"- Overall survival (OS) -Overall survival is defined as the time from randomization to death due to any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause (OS)."}
• {"endpoint_text":"- OS rate at 6 months and 1 year from randomization","definition_or_measurement_approach":"Proportion of participants alive at 6 months and 1 year from randomization."}
• {"endpoint_text":"- Incidence of treatment-emergent adverse events","definition_or_measurement_approach":"Safety assessment: incidence and severity of treatment-emergent adverse events (TEAEs) reported during study."}
• {"endpoint_text":"- Incidence of anti-tarlatamab antibody formation","definition_or_measurement_approach":"Assessment of immunogenicity: incidence of anti-drug (anti-tarlatamab) antibody formation."}

Belgium

Earliest CTIS Part Ii Submission Date

10-04-2025

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

329

Number Of Sites

3

Number Of Participants

10

France

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

346

Number Of Sites

3

Number Of Participants

6

Greece

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

440

Number Of Sites

7

Number Of Participants

37

Italy

Earliest CTIS Part Ii Submission Date

19-02-2025

Latest Decision Or Authorization Date

03-03-2026

Processing Time Days

377

Number Of Sites

1

Number Of Participants

7

Spain

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

338

Number Of Sites

5

Number Of Participants

30

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Excelya Greece CRO Single Member S.A.

Responsibilities

code 1

Name

Kayentis

Responsibilities

code 7

Name

Suvoda LLC

Responsibilities

code 3

Name

Q Squared Solutions Limited

Responsibilities

code 4

Name

Q Squared Solutions LLC

Responsibilities

code 4

Third parties

• {"country":"Belgium","full_name":"Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi","duties_or_roles":"Supplies 2 Questionnaires","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment Supplier","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Invicro LLC","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"Supplies 1 Questionnaire","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Amgen Research (Munich) GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"US Central IRB (CIRB)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Kayentis","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-term laboratory sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-term laboratory sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}