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Study of AMG 757 in Participants With Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT05060016
Recruitment Status : Not yet recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

The main aim of this study is to:

  • evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of AMG 757 for Part 1 only
  • evaluate anti-tumor activity of AMG 757 as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Small Cell Lung Cancer Drug: AMG 757 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 757 in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Estimated Study Start Date : November 29, 2021
Estimated Primary Completion Date : September 26, 2023
Estimated Study Completion Date : August 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: AMG 757 Low Dose
Participants will receive the low dose of AMG 757.
Drug: AMG 757
Intravenous (IV) infusion

Experimental: Part 1: AMG 757 High Dose
Participants will receive the high dose of AMG 757.
Drug: AMG 757
Intravenous (IV) infusion

Experimental: Part 2: Dose Expansion
Participants will receive the selected target dose of AMG 757 based on findings in Part 1.
Drug: AMG 757
Intravenous (IV) infusion




Primary Outcome Measures :
  1. Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  2. Part 1 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events [ Time Frame: Up to a maximum of 24 months ]
  3. Part 1 Only: Serum Concentrations of AMG 757 [ Time Frame: Up to a maximum of 24 months ]
  4. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to a maximum of 24 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to a maximum of 24 months ]
  2. Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to a maximum of 24 months ]
  3. Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to a maximum of 24 months ]
  4. Progression-free Survival (PFS) Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to a maximum of 24 months ]
  5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  6. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  7. Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  8. Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  9. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  10. Overall Survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 24 months ]
  11. Number of Participants who Experience One or More Treatment-emergent Adverse Events [ Time Frame: Up to a maximum of 24 months ]
  12. Serum Concentrations of AMG 757 [ Time Frame: Up to a maximum of 24 months ]
  13. Number of Participants who Experience Anti-AMG 757 Antibody Formation [ Time Frame: Up to a maximum of 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/assent prior to initiation of any study specific activities/procedures.
  • Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
  • Histologically or cytologically confirmed relapsed/refractory SCLC
  • Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 1.
  • Minimum life expectancy of 12 weeks.
  • Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of AMG 757.
  • Participants with treated brain metastases are eligible provided they meet defined criteria.

Exclusion Criteria:

Disease Related

  • Untreated or symptomatic brain metastases and leptomeningeal disease.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Participants who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • Unresolved toxicity from prior anti-tumor therapy, defined as per protocol.

Other Medical Conditions

  • History of other malignancy within the past 2 years, with exceptions
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757.
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757.
  • Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757.
  • Presence of any indwelling line or drain.
  • History of hypophysitis or pituitary dysfunction.
  • Exclusion of hepatitis infection based on the results and/or criteria per protocol.
  • Major surgery within 28 days of first dose AMG 757.
  • History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) infection unless agreed upon with medical monitor and meeting the following criterion: no acute symptoms of coronavirus disease 2019 (COVID 19) within 14 days prior to first dose of AMG 757 (counted from day of positive test for asymptomatic participants)

Prior/Concomitant Therapy

  • Participant received prior therapy with AMG 757.
  • Prior anti-cancer therapy within 28 days prior to first dose of AMG 757.
  • 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 AMG 757.
  • Live and live-attenuated vaccines within 4 weeks prior to the start off AMG 757 treatment, during treatment, and until end of last study dose.

Other Exclusions

  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 42 days after the last dose of AMG 757.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 42 days after the last dose of AMG 757.
  • Female participants planning to become pregnant while on study through 42 days after the last dose of AMG 757.
  • Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 42 days after the last dose of AMG 757.
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 42 days after the last dose of AMG 757.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 42 days after the last dose of AMG 757.
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
  • History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician.

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): NCT05060016


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

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: NCT05060016    
Other Study ID Numbers: 20200491
2021-002566-40 ( EudraCT Number )
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: August 2021
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:
Small Cell Lung Cancer
SCLC
AMG 757
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