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Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT03319940
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Drug: Tarlatamab Drug: Pembrolizumab Drug: CRS Mitigation Strategies Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional CRS mitigation strategies in participants with SCLC. The dose exploration phases of the study will estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of tarlatamab either as monotherapy or in combination with pembrolizumab. This will be followed by dose expansion phase to confirm RP2D and to obtain further safety and efficacy data.
Masking: None (Open Label)
Masking Description: The patient, investigator, investigative staff, medical monitor and care provider will not be masked for the study.
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Actual Study Start Date : December 26, 2017
Estimated Primary Completion Date : October 22, 2024
Estimated Study Completion Date : October 21, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
Tarlatamab monotherapy
 Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Experimental: Part C
Tarlatamab with Pembrolizumab
 Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Drug: Pembrolizumab
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
Experimental: Part D
Tarlatamab with additional CRS mitigation strategies
 Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Drug: CRS Mitigation Strategies
Participants will be treated with one of the CRS mitigation strategies.
Experimental: Part E
Tarlatamab administration with 24-hour monitoring
 Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Experimental: Part F

Tarlatamab administered in outpatient infusion centers with 8-hour monitoring

Optional wearable digital device substudy (US sites only)

 Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Experimental: Part G

Tarlatamab additional dosing schedule

Optional wearable digital device substudy (US sites only)

 Drug: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLT) for all indications [ Time Frame: 6 months ]
  2. Number of participants with treatment-emergent adverse events (AEs) for all indications [ Time Frame: 4 years ]
  3. Number of participants with treatment-related AEs for all indications [ Time Frame: 4 years ]
  4. Number of participants with clinically significant changes in vital signs for all indications [ Time Frame: 4 years ]
  5. Number of participants with significant changes in electrocardiogram (ECG) for all indications [ Time Frame: 4 years ]
  6. Number of participants with significant changes in physical examinations for all indications [ Time Frame: 4 years ]
  7. Number of participants with significant changes in clinical laboratory tests for all indications [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Maximum observed concentration (Cmax) following intravenous administration for all indications [ Time Frame: 4 years ]
  2. Minimum observed concentration (Cmin) following intravenous administration for all indications [ Time Frame: 4 years ]
  3. Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications [ Time Frame: 4 years ]
  4. Accumulation following multiple dosing for all indications [ Time Frame: 4 years ]
  5. Half-life (t1/2) following intravenous administration for all indications [ Time Frame: 4 years ]
  6. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 4 years ]
    Only for parts A, D, E, F, and G

  7. Duration of Response (DOR) for all indications [ Time Frame: 4 years ]
  8. Time to Response (TTR) [ Time Frame: 4 years ]
  9. 9-month Progression-Free Survival (PFS) for all indications [ Time Frame: 9 months ]
  10. 9-month Overall Survival (OS) for all indications [ Time Frame: 9 months ]

Eligibility Criteria
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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 time of signing the informed consent
  • Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • 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 prior to first dose of tarlatamab with exceptions
  • Major surgery within 28 days of first dose tarlatamab
  • Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
  • Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
  • Has 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
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
  • Participant 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 investigational product administration
Contacts and Locations
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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): NCT03319940


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

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03319940    
Other Study ID Numbers: 20160323
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
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: https://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:
Half-Life Extended (HLE) Bispecific T cell engager (BiTE®)
Delta-like protein 3 (DLL3)
Tarlatamab
Oncology
Immunology
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action