Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18 - 99
Clinical summary
Summary
The main objective of this study is to see whether treatment with durvalumab immunotherapy, carboplatin chemotherapy and etoposide chemotherapy is more effective when tarlatamab immunotherapy is also given.
Eligible participants will be randomly allocated to one of two treatment arms.
In the Experimental Arm, participants will recieve tarlatamab + durvalumab, carboplatin and etoposide for 4 cycles, followed by further treatment with tarlatamab and durvalumab.
In the Active Comparator Arm, participants will receive durvalumab, carboplatin and etoposide for 4 cycles, followed by further treatment with durvalumab,
All treatments will be administered as intravenous (IV) infusions.
Conditions
This trial is treating people with extensive stage small cell lung cancer who have not received prior treatment for their advanced disease
Eligibility
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 ES-SCLC (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.
- Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
- Minimum life expectancy ≥ 12 weeks.
Exclusion
- Participants can have no history of other malignancy in the last 2 years.
- Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- They will have no history of severe or life-threatening events to immune-mediated therapy.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- They will have no active autoimmune or inflammatory disorders.
- Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
- Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Amgen
Scientific Title
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)
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