TARLATAMAB for Small cell lung cancer (extensive stage)

Inclusion criteria

• {"criterion_text":"- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.\n- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n- Completed 4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of ES-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per RECIST 1.1. ·   Patients with 3 cycles of concurrent durvalumab are eligible, provided 4 cycles of platinum-etoposide chemotherapy are completed.\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n- Minimum life expectancy > 12 weeks.\n- Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.\n- Adequate organ function, defined as follows: Refer to protocol section 5.1 for more details."}

Exclusion criteria

• {"criterion_text":"- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.\n- History of solid organ transplantation.\n- Myocardial infarction and/or symptomatic congestive heart failure within 6 months prior to first dose of study treatment.\n- Major surgical procedures prior to first dose of study treatment.\n- History of arterial thrombosis within 6 months prior to first dose of study treatment.\n- Prior therapy with any selective inhibitor of the DLL3 pathway.\n- Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.\n- Male subjects unwilling to abstain from donating sperm during treatment\n- Female subjects who are breastfeeding or who plan to breastfeed while on study\n- Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment see Appendix 5 (Section 11.5)\n- Presence of active HIV or hepatitis infection\n- Evidence of ILD or active, non infectious pneumonitis.\n- Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.\n- Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment. see Appendix 5 (Section 11.5)\n- History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.\n- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment\n- Live and live-attenuated vaccines within 4 weeks prior to the first dose of study treatment. Inactive vaccinesand live viral non-replicating vaccines within 30 days prior to first dose of study treatment.\n- Female subjects planning to become pregnant or donate eggs while on study\n- History or evidence of any other clinically significant disorder, condition or disease\n- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.\n- Has received or is planning to receive consolidative chest radiation, for extensive stage disease. •\tProphylactic cranial irradiation is permitted, but must be completed prior to enrollment.\n- Prior history of severe or life-threatening events from any immune‑mediated therapy.\n- Treatment in an alternative investigational trial prior to enrollment.\n- Subject has known sensitivity to any of the products or components to be administered during dosing.\n- History of other malignancy within the past 2 years\n- Active or prior documented autoimmune or inflammatory disorders"}

Primary endpoints

• {"endpoint_text":"- OS","definition_or_measurement_approach":"OS defined as time from randomization to death from any cause."}

Secondary endpoints

• {"endpoint_text":"- PFS","definition_or_measurement_approach":"PFS defined as time from randomization to the first radiological documentation of disease progression or death from any cause, whichever occurs first."}
• {"endpoint_text":"- Incidence of treatment emergent adverse events after randomization","definition_or_measurement_approach":"Incidence measured after randomization (treatment-emergent adverse events)."}
• {"endpoint_text":"- PFS rate at 6 months 1 year and 2 years from randomization OS rate at 6 months 1 year 2 years, and 3 years from randomization TTP","definition_or_measurement_approach":"PFS and OS rates at specified timepoints and time to progression (TTP) based on investigator assessment per RECIST 1.1 where applicable."}
• {"endpoint_text":"- Serum concentrations of tarlatamab","definition_or_measurement_approach":"Measured serum concentrations of tarlatamab (pharmacokinetics)."}
• {"endpoint_text":"- Change from baseline up to week 13 and week 25 in disease symptoms of Cough Chest Pain and Dyspnea\t \"","definition_or_measurement_approach":"Change from baseline in specified disease symptoms up to weeks 13 and 25 (patient-reported outcomes)."}
• {"endpoint_text":"- Incidence of anti-tarlatamab antibody formation","definition_or_measurement_approach":"Incidence of anti-drug antibody formation assessed by immunogenicity assays."}
• {"endpoint_text":"- OR, DC, DoR.","definition_or_measurement_approach":"Objective response (OR), disease control (DC), and duration of response (DoR) assessed by investigator per RECIST 1.1."}
• {"endpoint_text":"- Time to first deterioration (TTD) for Physical function Global health status/Quality of life","definition_or_measurement_approach":"Time to first deterioration for physical function and global health status/quality of life measured via patient-reported instruments."}

Methods

• Physician-to-physician (Dr-to-Dr) referral letters and doctor-facing recruitment materials (country-specific Dr-to-Dr letters present).
• GP letters to primary care physicians to support referral (GP letter materials present).
• Patient-facing materials including patient study brochure, patient wallet card and patient visit reminder cards to inform and remind participants.
• Site-based pre-screening and outreach (pre-screening materials and pre-screening ICFs present).
• Web platform materials and electronic questionnaires (Web Platform Patient User Guide, eCOA/PROCTCAE materials) to support electronic data capture and patient engagement.

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

Icon Development Solutions LLC

Responsibilities

code:4

Name

Suvoda LLC

Responsibilities

code:3

Third parties

• {"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":"Kayentis","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-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":"Azenta US Inc.","duties_or_roles":"Laboratory sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"code:2","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Rad Md LLC","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"Radiological Assessments; code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Pre-screenning","organisation_type":"Hospital/Clinic/Other health care facility"}