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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 : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 29, 2022
First Posted Date  ICMJE May 4, 2022
Last Update Posted Date April 12, 2024
Actual Study Start Date  ICMJE August 24, 2022
Estimated Primary Completion Date December 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2022)
  • Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: 24 months ]
  • Number of Participants with Treatment-emergent Adverse Events (TEAE) [ Time Frame: 24 months ]
  • Number of Participants with Treatment-related Adverse Events [ Time Frame: 24 months ]
  • Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: 24 months ]
  • Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements [ Time Frame: 24 months ]
  • Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2022)
  • 6-month Progression-free Survival (PFS) [ Time Frame: 24 months ]
  • Objective Response (OR) [ Time Frame: 24 months ]
    Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Duration of Response (DOR) [ Time Frame: 24 months ]
  • Disease Control Rate(DCR) [ Time Frame: 24 months ]
  • Overall Survival (OS) [ Time Frame: 24 months ]
  • Serum Concentration of Tarlatamab [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Extensive Stage Small Cell Lung Cancer
Intervention  ICMJE
  • 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
  • Drug: Durvalumab
    Durvalumab will be administered as an intravenous (IV) infusion.
Study Arms  ICMJE
  • Experimental: Part 1: Dose Exploration Combination Regimen 1
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
    Interventions:
    • Drug: Tarlatamab
    • Drug: Carboplatin
    • Drug: Etoposide
    • Drug: Atezolizumab
  • Experimental: Part 2: Dose Exploration Combination Regimen 2
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
    Interventions:
    • Drug: Tarlatamab
    • Drug: Carboplatin
    • Drug: Etoposide
    • Drug: Atezolizumab
  • Experimental: Part 3: Dose Exploration Combination Regimen 3
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
    Interventions:
    • Drug: Tarlatamab
    • Drug: Carboplatin
    • Drug: Etoposide
    • Drug: Atezolizumab
  • Experimental: Part 4: Dose Expansion
    Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
    Interventions:
    • Drug: Tarlatamab
    • Drug: Carboplatin
    • Drug: Etoposide
    • Drug: Atezolizumab
  • Experimental: Part 5: Dose Exploration Maintenance
    Tarlatamab+Atezolizumab
    Interventions:
    • Drug: Tarlatamab
    • Drug: Atezolizumab
  • Experimental: Part 6: Dose Expansion Maintenance
    Expansion of Part 5 with Atezolizumab
    Interventions:
    • Drug: Tarlatamab
    • Drug: Atezolizumab
  • Experimental: Part 7: Dose Expansion
    Expansion of Part 1, 2, or 3 with Durvalumab
    Interventions:
    • Drug: Tarlatamab
    • Drug: Carboplatin
    • Drug: Etoposide
    • Drug: Durvalumab
  • Experimental: Part 8: Dose Expansion Maintenance
    Expansion of Part 5 with Durvalumab
    Interventions:
    • Drug: Tarlatamab
    • Drug: Durvalumab
  • Experimental: Part 9: Dose Expansion Maintenance
    Expansion with Tarlatamab+Durvalumab
    Interventions:
    • Drug: Tarlatamab
    • Drug: Durvalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2022)
340
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2022)
208
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date December 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Spain,   Switzerland,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05361395
Other Study ID Numbers  ICMJE 20200469
2021-005462-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Current Responsible Party Amgen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP