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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05361395
Recruitment Status : Recruiting
First Posted : May 4, 2022
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Extensive Stage Small Cell Lung Cancer Drug: Tarlatamab Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab Drug: Durvalumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2022
Estimated Primary Completion Date : November 14, 2024
Estimated Study Completion Date : November 16, 2025


Arm Intervention/treatment
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: 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 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: 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 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.




Primary Outcome Measures :
  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 Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05361395


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Show Show 42 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05361395    
Other Study ID Numbers: 20200469
2021-005462-17 ( EudraCT Number )
First Posted: May 4, 2022    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Atezolizumab
Durvalumab
AMG 757
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological