20200469 - A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer.

Studio Clinico

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.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-005462-17

Data di inserimento: 31.05.2023

Promotore

Amgen

Principal Investigator ITALIA

AOU R. Dulbecco, Catanzaro (località Germaneto)

Riferimento: Prof. Pierfrancesco Tassone

Telefono: 09613647029

Email: tassone@unicz.it

Localita: Catanzaro (località Germaneto)