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JOURNAL ONKOLOGIE – STUDIE

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Rekrutierend

NCT-Nummer:
NCT05361395

Studienbeginn:
August 2022

Letztes Update:
12.04.2024

Wirkstoff:
Tarlatamab, Carboplatin, Etoposide, Atezolizumab, Durvalumab

Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 44)

Universitaetsklinikum Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
University of Southern California, Norris Comprehensive Cancer Center
90033 Los Angeles
United StatesRekrutierend» Google-Maps
Christiana Care Health Services
19713 Newark
United StatesRekrutierend» Google-Maps
Henry Ford Health System
48202 Detroit
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08901 New Brunswick
United StatesRekrutierend» Google-Maps
New York University Langone Medical Center
10016 New York
United StatesRekrutierend» Google-Maps
The University of North Carolina at Chapel Hill
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Avera Cancer Institute
57105 Sioux Falls
United StatesRekrutierend» Google-Maps
Swedish Cancer Institute Medical Oncology
98104 Seattle
United StatesRekrutierend» Google-Maps
West Virginia University Health Sciences Center
26506 Morgantown
United StatesRekrutierend» Google-Maps
Universitair Ziekenhuis Antwerpen
2650 Edegem
BelgiumRekrutierend» Google-Maps
Algemeen Ziekenhuis Maria Middelares
9000 Gent
BelgiumRekrutierend» Google-Maps
Jessa Ziekenhuis - Campus Virga Jesse
3500 Hasselt
BelgiumRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
CHU de Quebec Hopital de l Enfant Jesus
G1R 2J6 Quebec
CanadaRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
44800 Saint Herblain
FranceRekrutierend» Google-Maps
Hadassah Ein-Kerem Medical Center
9112001 Jerusalem
IsraelRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Renato Dulbecco
88100 Catanzaro
ItalyRekrutierend» Google-Maps
Fondazione IRCCS San Gerardo dei Tintori
20900 Monza (MB)
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori Regina Elena
00144 Rome
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
135-8550 Koto-ku
JapanRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Universitair Medisch Centrum Groningen
9713 GZ Groningen
NetherlandsRekrutierend» Google-Maps
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
National Cheng Kung University Hospital
70403 Tainan
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Number of Participants with a Dose Limiting Toxicity (DLT) (Time Frame - 24 months)

2. Number of Participants with Treatment-emergent Adverse Events (TEAE) (Time Frame - 24 months)

3. Number of Participants with Treatment-related Adverse Events (Time Frame - 24 months)

4. Number of Participants with Clinically Significant Changes in Vital Signs (Time Frame - 24 months)

5. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements (Time Frame - 24 months)

6. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests (Time Frame - 24 months)

Secondary outcome:

1. 6-month Progression-free Survival (PFS) (Time Frame - 24 months)

2. Objective Response (OR) (Time Frame - 24 months):
Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

3. Duration of Response (DOR) (Time Frame - 24 months)

4. Disease Control Rate(DCR) (Time Frame - 24 months)

5. Overall Survival (OS) (Time Frame - 24 months)

6. Serum Concentration of Tarlatamab (Time Frame - 24 months)

Studien-Arme

  • Experimental: Part 1: Dose Exploration Combination Regimen 1
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
  • Experimental: Part 2: Dose Exploration Combination Regimen 2
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
  • Experimental: Part 3: Dose Exploration Combination Regimen 3
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
  • Experimental: Part 4: Dose Expansion
    Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
  • Experimental: Part 5: Dose Exploration Maintenance
    Tarlatamab+Atezolizumab
  • Experimental: Part 6: Dose Expansion Maintenance
    Expansion of Part 5 with Atezolizumab
  • Experimental: Part 7: Dose Expansion
    Expansion of Part 1, 2, or 3 with Durvalumab
  • Experimental: Part 8: Dose Expansion Maintenance
    Expansion of Part 5 with Durvalumab
  • Experimental: Part 9: Dose Expansion Maintenance
    Expansion with Tarlatamab+Durvalumab

Geprüfte Regime

  • Tarlatamab (AMG 757):
    Tarlatamab will be administered as an intravenous (IV) infusion.
  • Carboplatin:
    Carboplatin will be administered as an intravenous (IV) infusion.
  • Etoposide:
    Etoposide will be administered as an intravenous (IV) infusion.
  • Atezolizumab (Tecentriq):
    Atezolizumab will be administered as an intravenous (IV) infusion.
  • Durvalumab:
    Durvalumab will be administered as an intravenous (IV) infusion.

Quelle: ClinicalTrials.gov


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