First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Extensive Stage Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer focused on measuring 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
Eligibility Criteria
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 Extended 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.
- History of solid organ transplantation.
- 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.
Sites / Locations
- University of Southern California, Norris Comprehensive Cancer CenterRecruiting
- Christiana Care Health ServicesRecruiting
- Henry Ford Health SystemRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- New York University Langone Medical CenterRecruiting
- The University of North Carolina at Chapel HillRecruiting
- Avera Cancer InstituteRecruiting
- Swedish Cancer Institute Medical OncologyRecruiting
- West Virginia University Health Sciences CenterRecruiting
- Chris OBrien LifehouseRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Algemeen Ziekenhuis Maria MiddelaresRecruiting
- Jessa Ziekenhuis - Campus Virga JesseRecruiting
- AZ Delta Campus RumbekeRecruiting
- Princess Margaret Cancer CentreRecruiting
- CHU de Quebec Hopital de l Enfant JesusRecruiting
- RigshospitaletRecruiting
- Centre Leon BerardRecruiting
- Centre Hospitalier Universitaire de Nantes, Hôpital Nord LaënnecRecruiting
- Gustave RoussyRecruiting
- Universitaetsklinikum Carl Gustav CarusRecruiting
- Universitaetsklinikum EssenRecruiting
- Universitätsklinikum FreiburgRecruiting
- Rambam Medical CenterRecruiting
- Hadassah Ein-Kerem Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Azienda Ospedaliera Universitaria Renato DulbeccoRecruiting
- Fondazione IRCCS San Gerardo dei TintoriRecruiting
- Istituti Fisioterapici Ospitalieri Regina Elena San GallicanoRecruiting
- National Cancer Center Hospital EastRecruiting
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
- Seoul National University HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i PujolRecruiting
- Hospital Universitari Vall d HebronRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Universitaetsspital BaselRecruiting
- Inselspital BernRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1: Dose Exploration Combination Regimen 1
Part 2: Dose Exploration Combination Regimen 2
Part 3: Dose Exploration Combination Regimen 3
Part 4: Dose Expansion
Part 5: Dose Exploration Maintenance
Part 6: Dose Expansion Maintenance
Part 7: Dose Expansion
Part 8: Dose Expansion Maintenance
Part 9: Dose Expansion Maintenance
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Tarlatamab+Atezolizumab
Expansion of Part 5 with Atezolizumab
Expansion of Part 1, 2, or 3 with Durvalumab
Expansion of Part 5 with Durvalumab
Expansion with Tarlatamab+Durvalumab