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)
Study of Investigational Medication in Combination with Other Treatments for Extensive Stage Small-Cell Lung Cancer
Misty D. Shields, MD, PhD
Primary Investigator
Brief description of study
The main objective of the study is to 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).
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
Primary Objectives:
- 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)
Secondary Objectives:
- Compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide as assessed by progression free survival (PFS) based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide as assessed by objective response (OR), disease control (DC) and duration of response (DOR) based on investigator assessment per RECIST 1.1
- Compare the efficacy of tarlatamab in combination with durvalumab,carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide as assessed by:
- PFS at 6 months, 1 year, and 2 years from randomization based on investigator assessment per RECIST 1.1
- OS at 6 months, 1 year, 2 years, and 3 years from randomization
- Time to progression (TTP) based on investigator assessment
- Compare the safety and tolerability of tarlatamab in combination with durvalumab, carboplatin, and etoposide to the combination of durvalumab, carboplatin and etoposide
- Characterize the pharmacokinetics (PK) of tarlatamab when administered in combination with durvalumab, carboplatin and etoposide
- Evaluate the immunogenicity of tarlatamab.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Small-cell Lung Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- 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 Criteria:
- Participants can have no history of other malignancy in the last 2 years.
- Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
- 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.
This study investigates the effects of an investigational medication combined with other treatments for extensive stage small-cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread extensively within the body. The purpose is to see if the investigational medication can improve overall survival when used with other treatments compared to the standard treatment alone.
Participants in the study will receive either the investigational medication along with durvalumab, carboplatin, and etoposide, or just durvalumab, carboplatin, and etoposide. The study will involve regular assessments to monitor the effects of the treatments and any side effects. Participants will undergo various tests and procedures as part of the study.
- Who can participate: Adults aged 18 years and older with extensive stage small-cell lung cancer can participate. Key eligibility includes having a measurable disease and being suitable for specific chemotherapy regimens. Participants must not have had other cancers in the past two years or severe immune-related conditions.
- Study details: Participants will receive either the investigational medication with durvalumab, carboplatin, and etoposide, or just durvalumab, carboplatin, and etoposide. The investigational medication is being studied to see if it can improve survival rates when combined with these treatments.
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