Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide versus Durvalumab, Carboplatin, and Etoposide in First-Line ES-SCLC (DeLLphi-312)

Trial details

Who runs it

Amgen Inc.

Trial code

EU 2024-520050-38-00

Record updated

2026. augusztus 12.

Original description

Primary: Compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).Read full original descriptionShow less

A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

Primary: Compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Inclusion: Participant has provided informed consent before initiation of any study-specific activities/procedures; Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years; Histologically or cytologically documented extensive-stage small-cell lung cancer (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan; Measurable disease as defined per RECIST 1.1; No prior treatment for SCLC. NOTE: (see section 5.1 of the Protocol for additional details); Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; Minimum life expectancy ≥ 12 weeks; Adequate organ function, defined as follows:  Hematological function: o Absolute neutrophil count ≥ 1.5 x 10^9/L o Platelet count ≥ 100 x 10^9/L o Hemoglobin ≥ 9 g/dL (90 g/L)  Coagulation function: o Prothrombin 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 participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 2 weeks prior to randomization  Renal function: o Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 60 mL/min/1.73 m2  Hepatic function: o aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5 x ULN for participants with liver involvement) o Total bilirubin (TBL) ≤ 1.5 x ULN (or ≤ 2 x ULN for participants with liver involvement), with the exception of participants with Gilbert's disease  Pulmonary function: o No oxygen supplementation  Cardiac function: o Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) [or multigated acquisition (MUGA) scan if ECHO is not available], and no electrocardiogram (ECG) finding related to acute/subacute myocardial ischemia and/or clinically significant arrythmia.

Exclusion: Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment; History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment; Major surgical procedures within XX days prior to first dose of study treatment; Has received or is planning to receive consolidative chest radiation, for extensive-stage disease; Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the DLL3 pathway; Treatment in an alternative investigational trial within XX days prior to enrollment; Participant with symptoms and/or signs of systemic infection requiring parental oral antibiotics within 7 days prior to the first dose of study treatment; Prior history of severe or life-threatening events from any immune-mediated therapy; Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment (see Protocol section 5.2 for additional details); Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (eg, non-live or nonreplicating agent) and live viral non-replicating vaccines (eg,Jynneos for mpox infection) within 3 days prior to first dose of study treatment; Receiving another anticancer therapy for a malignancy other than SCLC. Adjuvant hormonal therapy for resected breast cancer is permitted; Active or prior documented autoimmune or inflammatory disorders; Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease; Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis; History of solid organ transplant; Presence of active HIV or active hepatitis infection; History of allergic reactions or acute hypersensitivity reactions to antibody therapies, carboplatin, etoposide or pegfilgrastim; History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures or completion; History of other malignancy within the past 2 years, with the following exceptions (see Protocol 5.2 for exceptions); Participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test; Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional (see Protocol section 5.2 for details); Participants who are breastfeeding or who plan to breastfeed while on study through (see Protocol section 5.2 for details); Participants planning to become pregnant while on study through (see Protocol section 5.2 for details); Participants with a partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional (see Protocol section 5.2 for details); Participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional (see Protocol section 5.2 for details); Participants unwilling to abstain from donating sperm during treatment and for an additional (see Protocol section 5.2 for details); Participant has known sensitivity to any of the products or components to be administered during dosing; Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the Participant and investigator’s knowledge. Participants who are unable to complete clinical outcome assessments questionnaires are eligible.

EU CTIS 2024-520050-38-00