Extensive Stage Small Cell Lung Cancer
Conditions
Keywords
Extensive Stage Small Cell Lung Cancer, ES-SCLC, SCLC, Lung Cancer, AMG 757, Bi-Specific T-Cell Engager, BiTE, Inmunotherapy, Immunooncology, Inmuno-oncology, DLL3, Delta Like Protein 3
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.
Interventions
DRUGTarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
DRUGCarboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
DRUGEtoposide
Etoposide will be administered as an intravenous (IV) infusion.
DRUGAtezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
DRUGDurvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 6-month Progression-free Survival (PFS) | 24 months | — |
| 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 | — |
Countries
Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, South Korea, Spain, Switzerland, Taiwan, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed