Extensive Stage Small Cell Lung Cancer
Conditions
Interventions
- Experimental: Part 1: Dose Exploration Combination Regimen 1
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Interventions:
- Drug: Tarlatamab
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Atezoli
Sponsors
Tagashira Shuzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. Age greater than or equal to 18 years old at the same time of signing the informed consent. 3. Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC. 4. Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted. 5. Eastern Cooperative Oncology Group (ECOG) 0 to 1. 6. Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria. 7. Adequate organ function as defined in protocol.
Exclusion criteria
Exclusion criteria: 1. History of other malignancy within the past 2 years with exceptions. 2. Major surgery within 28 days of study day 1. 3. Untreated or symptomatic brain metastases and leptomeningeal disease. 4. 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. 5. History of immune-related colitis. 6. History or evidence of interstitial lung disease or active, non-infectious pneumonitis. 7. 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. 8. 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. 9. History of hypophysitis or pituitary dysfunction. 10. History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation. 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of Participants with a Dose Limiting Toxicity (DLT) [Time Frame: 24 months] 2. Number of Participants with Treatment-emergent Adverse Events (TEAE) [Time Frame: 24 months] 3. Number of Participants with Treatment-related Adverse Events [Time Frame: 24 months] 4. Number of Participants with Clinically Significant Changes in Vital Signs [Time Frame: 24 months] 5. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements[Time Frame: 24 months] 6. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [Time Frame: 24 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 6-month Progression-free Survival (PFS) [Time Frame: 24 months] 2. Objective Response (OR) [Time Frame: 24 months] Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 3. Duration of Response (DOR) [Time Frame: 24 months] 4. Disease Control Rate(DCR) [Time Frame: 24 months] 5. Overall Survival (OS) [Time Frame: 24 months] 6. Serum Concentration of Tarlatamab [Time Frame: 24 months] | — |
Countries
Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Korea, Netherlands, Spain, Switzerland, Taiwan, United States
Contacts
Public ContactContact Local
Amgen K.K.
Outcome results
None listed