Patologia: Neoplasie del polmone
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: 1, I B
Linee di trattamento: Prima linea
Criteri di inclusione:
- 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.
Criteri di esclusione:
- 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.
Trattamento sperimentale:
Part 1: Dose Exploration Combination Regimen 1
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Part 2: Dose Exploration Combination Regimen 2
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Part 3: Dose Exploration Combination Regimen 3
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Part 4: Dose Expansion
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Part 5: Dose Exploration Maintenance
Tarlatamab+Atezolizumab
Part 6: Dose Expansion Maintenance
Expansion of Part 5 with Atezolizumab
Part 7: Dose Expansion
Expansion of Part 1, 2, or 3 with Durvalumab
Part 8: Dose Expansion Maintenance
Expansion of Part 5 with Durvalumab
Part 9: Dose Expansion Maintenance
Expansion with Tarlatamab+Durvalumab.
Trattamento di controllo:
NA
Note generali:
Le parti dello studio aperte sono la 2, la 6 e la 8 ma, ad oggi, l'Italia può arruolare pazienti solo nella parte 8. Con l'approvazione dell'emendamento al protocollo versione 3.0 sarà possibile arruolare anche nella parte 2 dello studio.
A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
Riferimento: Prof. Diego Cortinovis
Email: d.cortinovis@asst-monza.it
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Riferimento: Dr.ssa Lorenza Landi
Telefono: 0652662205
Email: lorenza.landi@ifo.it
Università degli Studi Magna Græcia
Viale Europa - 88100 Germaneto - CZ
AOU R. Dulbecco
Riferimento: Prof. Pierfrancesco Tassone
Telefono: 09613647029
Email: tassone@unicz.it
Numero di iscrizione a registro: 2021-005462-17
Data di inserimento: 31.05.2023
Amgen
AOU R. Dulbecco, Catanzaro (località Germaneto)
Riferimento: Prof. Pierfrancesco Tassone
Telefono: 09613647029
Email: tassone@unicz.it
Localita: Catanzaro (località Germaneto)