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Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide versus Durvalumab, Carboplatin, and Etoposide in First-Line ES-SCLC (DeLLphi-312)
EU CTIS ID: 2024-520050-38-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- 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.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within XX days prior to first dose of study treatment.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- 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.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within XX days prior to first dose of study treatment.
- Presence of active HIV or active hepatitis infection.
- 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.
- 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).
- History of allergic reactions or acute hypersensitivity reactions to antibody therapies, carboplatin, etoposide or pegfilgrastim.
- 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 of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
- 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.
- 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.
- 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.
- History of other malignancy within the past 2 years, with the following exceptions (see Protocol 5.2 for exceptions)
- Active or prior documented autoimmune or inflammatory disorders
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- China
- Mexico
- Israel
- Japan
- Korea, Republic of
- United States
- Switzerland
- Hong Kong
- Australia
- Taiwan
- Brazil
- Turkey
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; China; Mexico; Israel; Japan; Korea, Republic of and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.