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

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tarlatamab
Carboplatin
Etoposide
Atezolizumab
Durvalumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

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.
  • 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.

Sites / Locations

  • University of Southern California, Norris Comprehensive Cancer CenterRecruiting
  • Christiana Care Health ServicesRecruiting
  • Henry Ford Health SystemRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • New York University Langone Medical CenterRecruiting
  • The University of North Carolina at Chapel HillRecruiting
  • Avera Cancer InstituteRecruiting
  • Swedish Cancer Institute Medical OncologyRecruiting
  • West Virginia University Health Sciences CenterRecruiting
  • Chris OBrien LifehouseRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • Algemeen Ziekenhuis Maria MiddelaresRecruiting
  • Jessa Ziekenhuis - Campus Virga JesseRecruiting
  • AZ Delta Campus RumbekeRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • CHU de Quebec Hopital de l Enfant JesusRecruiting
  • RigshospitaletRecruiting
  • Centre Leon BerardRecruiting
  • Centre Hospitalier Universitaire de Nantes, Hôpital Nord LaënnecRecruiting
  • Gustave RoussyRecruiting
  • Universitaetsklinikum Carl Gustav CarusRecruiting
  • Universitaetsklinikum EssenRecruiting
  • Universitätsklinikum FreiburgRecruiting
  • Rambam Medical CenterRecruiting
  • Hadassah Ein-Kerem Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Azienda Ospedaliera Universitaria Renato DulbeccoRecruiting
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting
  • Istituti Fisioterapici Ospitalieri Regina Elena San GallicanoRecruiting
  • National Cancer Center Hospital EastRecruiting
  • The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Universitair Medisch Centrum GroningenRecruiting
  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitari Vall d HebronRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Universitaetsspital BaselRecruiting
  • Inselspital BernRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1: Dose Exploration Combination Regimen 1

Part 2: Dose Exploration Combination Regimen 2

Part 3: Dose Exploration Combination Regimen 3

Part 4: Dose Expansion

Part 5: Dose Exploration Maintenance

Part 6: Dose Expansion Maintenance

Part 7: Dose Expansion

Part 8: Dose Expansion Maintenance

Part 9: Dose Expansion Maintenance

Arm Description

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

Tarlatamab+Atezolizumab

Expansion of Part 5 with Atezolizumab

Expansion of Part 1, 2, or 3 with Durvalumab

Expansion of Part 5 with Durvalumab

Expansion with Tarlatamab+Durvalumab

Outcomes

Primary Outcome Measures

Number of Participants with a Dose Limiting Toxicity (DLT)
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Number of Participants with Treatment-related Adverse Events
Number of Participants with Clinically Significant Changes in Vital Signs
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2022
Last Updated
August 9, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05361395
Brief Title
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 Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
November 14, 2024 (Anticipated)
Study Completion Date
November 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Exploration Combination Regimen 1
Arm Type
Experimental
Arm Description
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Arm Title
Part 2: Dose Exploration Combination Regimen 2
Arm Type
Experimental
Arm Description
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Arm Title
Part 3: Dose Exploration Combination Regimen 3
Arm Type
Experimental
Arm Description
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Arm Title
Part 4: Dose Expansion
Arm Type
Experimental
Arm Description
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Arm Title
Part 5: Dose Exploration Maintenance
Arm Type
Experimental
Arm Description
Tarlatamab+Atezolizumab
Arm Title
Part 6: Dose Expansion Maintenance
Arm Type
Experimental
Arm Description
Expansion of Part 5 with Atezolizumab
Arm Title
Part 7: Dose Expansion
Arm Type
Experimental
Arm Description
Expansion of Part 1, 2, or 3 with Durvalumab
Arm Title
Part 8: Dose Expansion Maintenance
Arm Type
Experimental
Arm Description
Expansion of Part 5 with Durvalumab
Arm Title
Part 9: Dose Expansion Maintenance
Arm Type
Experimental
Arm Description
Expansion with Tarlatamab+Durvalumab
Intervention Type
Drug
Intervention Name(s)
Tarlatamab
Other Intervention Name(s)
AMG 757
Intervention Description
Tarlatamab will be administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide will be administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered as an intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Durvalumab will be administered as an intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
Number of Participants with a Dose Limiting Toxicity (DLT)
Time Frame
24 months
Title
Number of Participants with Treatment-emergent Adverse Events (TEAE)
Time Frame
24 months
Title
Number of Participants with Treatment-related Adverse Events
Time Frame
24 months
Title
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame
24 months
Title
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Time Frame
24 months
Title
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time Frame
24 months
Secondary Outcome Measure Information:
Title
6-month Progression-free Survival (PFS)
Time Frame
24 months
Title
Objective Response (OR)
Description
Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
24 months
Title
Duration of Response (DOR)
Time Frame
24 months
Title
Disease Control Rate(DCR)
Time Frame
24 months
Title
Overall Survival (OS)
Time Frame
24 months
Title
Serum Concentration of Tarlatamab
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California, Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Cancer Institute Medical Oncology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia University Health Sciences Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Name
Chris OBrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta Campus Rumbeke
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Quebec Hopital de l Enfant Jesus
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon cedex 8
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Ein-Kerem Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Renato Dulbecco
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza (MB)
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Universitaetsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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