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20200469 - DeLLphi-303 - 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.
- 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.

Schema di trattamento: 

Experimental: Part 1: Dose Exploration Combination Regimen 1
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq

Experimental: Part 2: Dose Exploration Combination Regimen 2
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq

Experimental: Part 3: Dose Exploration Combination Regimen 3
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq

Experimental: Part 4: Dose Expansion
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq

Experimental: Part 5: Dose Exploration Maintenance
Tarlatamab+Atezolizumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq

Experimental: Part 6: Dose Expansion Maintenance
Expansion of Part 5 with Atezolizumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq

Experimental: Part 7: Dose Expansion
Expansion of Part 1, 2, or 3 with Durvalumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Drug: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Drug: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.

Experimental: Part 8: Dose Expansion Maintenance
Expansion of Part 5 with Durvalumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.

Experimental: Part 9: Dose Expansion Maintenance
Expansion with Tarlatamab+Durvalumab
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757
Drug: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.

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

Obiettivi primari dello studio: 

- Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: 24 months ]
- Number of Participants with Treatment-emergent Adverse Events (TEAE) [ Time Frame: 24 months ]
- Number of Participants with Treatment-related Adverse Events [ Time Frame: 24 months ]
- Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: 24 months ]
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements [ Time Frame: 24 months ]
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: 24 months ].

Obiettivi secondari dello studio: 

- 6-month Progression-free Survival (PFS) [ Time Frame: 24 months ]
- Objective Response (OR) [ Time Frame: 24 months ] Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Duration of Response (DOR) [ Time Frame: 24 months ]
- Disease Control Rate(DCR) [ Time Frame: 24 months ]
- Overall Survival (OS) [ Time Frame: 24 months ]
- Serum Concentration of Tarlatamab [ Time Frame: 24 months ]

Centri partecipanti

Nord Italia

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

 

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

 

Sud Italia e isole

Università degli Studi Magna Græcia
Viale Europa - 88100 Germaneto - CZ
AOU R. Dulbecco

Riferimento: Prof. Pierfrancesco Tassone
Telefono: 09613647029
Email: tassone@unicz.it

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)

 

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