First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Phase 1
Recruiting
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05361395
- Lead Sponsor
- Amgen
- Brief Summary
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
Inclusion Criteria
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age greater than or equal to 18 years old at the same time of signing the informed consent.
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
- Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
- Adequate organ function as defined in protocol.
Exclusion Criteria
- History of other malignancy within the past 2 years with exceptions.
- Major surgery within 28 days of study day 1.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
- Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
- NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
- History of hypophysitis or pituitary dysfunction.
- History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 4: Dose Expansion Atezolizumab Expansion of Part 1, Part 2, or Part 3 with Atezolizumab Part 5: Dose Exploration Maintenance Tarlatamab Tarlatamab+Atezolizumab Part 5: Dose Exploration Maintenance Atezolizumab Tarlatamab+Atezolizumab Part 6: Dose Expansion Maintenance Atezolizumab Expansion of Part 5 with Atezolizumab Part 1: Dose Exploration Combination Regimen 1 Tarlatamab Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 7: Dose Expansion Tarlatamab Expansion of Part 1, 2, or 3 with Durvalumab Part 7: Dose Expansion Durvalumab Expansion of Part 1, 2, or 3 with Durvalumab Part 1: Dose Exploration Combination Regimen 1 Carboplatin Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 1: Dose Exploration Combination Regimen 1 Etoposide Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 1: Dose Exploration Combination Regimen 1 Atezolizumab Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 2: Dose Exploration Combination Regimen 2 Tarlatamab Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 2: Dose Exploration Combination Regimen 2 Carboplatin Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 2: Dose Exploration Combination Regimen 2 Etoposide Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 2: Dose Exploration Combination Regimen 2 Atezolizumab Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 3: Dose Exploration Combination Regimen 3 Etoposide Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 3: Dose Exploration Combination Regimen 3 Carboplatin Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 3: Dose Exploration Combination Regimen 3 Atezolizumab Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 4: Dose Expansion Etoposide Expansion of Part 1, Part 2, or Part 3 with Atezolizumab Part 4: Dose Expansion Carboplatin Expansion of Part 1, Part 2, or Part 3 with Atezolizumab Part 6: Dose Expansion Maintenance Tarlatamab Expansion of Part 5 with Atezolizumab Part 7: Dose Expansion Carboplatin Expansion of Part 1, 2, or 3 with Durvalumab Part 7: Dose Expansion Etoposide Expansion of Part 1, 2, or 3 with Durvalumab Part 8: Dose Expansion Maintenance Tarlatamab Expansion of Part 5 with Durvalumab Part 8: Dose Expansion Maintenance Durvalumab Expansion of Part 5 with Durvalumab Part 9: Dose Expansion Maintenance Tarlatamab Expansion with Tarlatamab+Durvalumab Part 9: Dose Expansion Maintenance Durvalumab Expansion with Tarlatamab+Durvalumab Part 3: Dose Exploration Combination Regimen 3 Tarlatamab Tarlatamab+Atezolizumab+Carboplatin+Etoposide Part 4: Dose Expansion Tarlatamab Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
- Primary Outcome Measures
Name Time Method Number of Participants with a Dose Limiting Toxicity (DLT) 24 months Number of Participants with Treatment-emergent Adverse Events (TEAE) 24 months Number of Participants with Treatment-related Adverse Events 24 months Number of Participants with Clinically Significant Changes in Vital Signs 24 months Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements 24 months Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests 24 months
- Secondary Outcome Measures
Name Time Method Objective Response (OR) 24 months Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Duration of Response (DOR) 24 months Disease Control Rate(DCR) 24 months Overall Survival (OS) 24 months Serum Concentration of Tarlatamab 24 months 6-month Progression-free Survival (PFS) 24 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of tarlatamab and PD-L1 inhibition in NCT05361395 for ES-SCLC?
How does tarlatamab plus carboplatin/etoposide/PD-L1 compare to standard ES-SCLC regimens in efficacy?
Which biomarkers predict response to tarlatamab in combination with PD-L1 inhibitors for ES-SCLC?
What are the safety profiles and management strategies for adverse events in NCT05361395's ES-SCLC trial?
What are the current PD-L1 inhibitor combinations being explored for ES-SCLC besides tarlatamab?
Trial Locations
- Locations (44)
University of Southern California, Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
🇺🇸New York, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Swedish Cancer Institute Medical Oncology
🇺🇸Seattle, Washington, United States
West Virginia University Health Sciences Center
🇺🇸Morgantown, West Virginia, United States
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Scroll for more (34 remaining)University of Southern California, Norris Comprehensive Cancer Center🇺🇸Los Angeles, California, United States