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AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Primary Purpose

Small Cell Lung Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tarlatamab
AMG 404
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, SCLC, Lung Cancer, AMG 757, AMG 404, Tarlatamab

Eligibility Criteria

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

Inclusion Criteria:

  • Participant has provided informed consent/assent 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
  • Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1
  • Participants with treated 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 first dose of tarlatamab
  • Untreated or symptomatic brain metastases and leptomeningeal disease
  • Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab

Exceptions:

  • Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1.

  • Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab

    • Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
    • 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 any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
    • Participants with 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 tarlatamab
    • History of solid organ transplantation
    • History of hypophysitis or pituitary dysfunction
    • 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

  • Northwestern University, Robert H Lurie Comprehensive Cancer Center
  • University of Kentucky
  • Wake Forest Baptist Comprehensive Cancer Research Center
  • University Hospitals Cleveland Medical Center
  • Medical University of South Carolina
  • Tennessee Oncology, PLLC
  • Huntsman Cancer Institute
  • Medizinische Universitaet Innsbruck
  • Universitaetsklinikum Allgemeines Krankenhaus Wien
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • National Cancer Center Hospital East
  • National Cancer Center Hospital
  • National University Hospital
  • National Cancer Centre Singapore
  • Chung Shan Medical University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1: Dose Exploration

Phase 2: Dose Expansion

Arm Description

The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).

Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Duration of Response (DOR)
Disease Control Rate (DCR)
Progression-free Survival (PFS)
Overall Survival (OS)
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404
Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404

Full Information

First Posted
May 10, 2021
Last Updated
October 12, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04885998
Brief Title
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Official Title
A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
July 12, 2023 (Actual)
Study Completion Date
January 11, 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
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, SCLC, Lung Cancer, AMG 757, AMG 404, Tarlatamab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Dose Exploration
Arm Type
Experimental
Arm Description
The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
Arm Title
Phase 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.
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)
AMG 404
Intervention Description
AMG 404 will be administered as an intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
Number of Participants with a Dose Limiting Toxicity (DLT)
Time Frame
28 days
Title
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Time Frame
24 months
Title
Number of Participants with a Treatment-related Adverse Event
Time Frame
24 months
Title
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Time Frame
Baseline to Month 24
Title
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Time Frame
Baseline to Month 24
Title
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Time Frame
Baseline to Month 24
Secondary Outcome Measure Information:
Title
Objective Response (OR) 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
Progression-free Survival (PFS)
Time Frame
24 months
Title
Overall Survival (OS)
Time Frame
24 months
Title
Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404
Time Frame
24 months
Title
Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404
Time Frame
24 months
Title
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404
Time Frame
24 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has provided informed consent/assent 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 Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen Eastern Cooperative Oncology Group (ECOG) 0 to 1 Participants with treated 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 first dose of tarlatamab Untreated or symptomatic brain metastases and leptomeningeal disease Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab Exceptions: Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1. Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible 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 any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis Participants with 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 tarlatamab History of solid organ transplantation History of hypophysitis or pituitary dysfunction 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University, Robert H Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Wake Forest Baptist Comprehensive Cancer Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

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

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

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