Clinical trial NCT05361395: First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Official title: 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 (DeLLphi-303)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: 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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Number of Participants with a Dose Limiting Toxicity (DLT)
timeFrame: 24 months
measure: Number of Participants with Treatment-emergent Adverse Events (TEAE)
timeFrame: 24 months
measure: Number of Participants with Treatment-related Adverse Events
timeFrame: 24 months
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: 24 months
measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
timeFrame: 24 months
measure: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
timeFrame: 24 months
Secondary outcomes:
measure: 6-month Progression-free Survival (PFS)
timeFrame: 24 months
measure: Objective Response (OR)
timeFrame: 24 months
measure: Duration of Response (DOR)
timeFrame: 24 months
measure: Disease Control Rate(DCR)
timeFrame: 24 months
measure: Overall Survival (OS)
timeFrame: 24 months
measure: Serum Concentration of Tarlatamab
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: New York University Grossman School of Medicine and New York University Langone Hospitals
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Seattle
country: United States
facility: Swedish Cancer Institute Medical Oncology
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Health Sciences Center
state: West Virginia
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Roeselare
country: Belgium
facility: AZ Delta Campus Rumbeke
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Quebec
country: Canada
facility: CHU de Quebec Hopital de l Enfant Jesus
city: Kobenhavn
country: Denmark
facility: Rigshospitalet
city: Lyon cedex 8
country: France
facility: Centre Leon Berard
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
city: Villejuif
country: France
facility: Gustave Roussy
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Renato Dulbecco
city: Monza (MB)
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Badalona
country: Spain
facility: Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: