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Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) (DeLLphi-306)

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: NCT06117774
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).

Condition or disease Intervention/treatment Phase
Limited Stage Small Cell Lung Cancer Small Cell Lung Cancer Drug: Tarlatamab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Actual Study Start Date : February 20, 2024
Estimated Primary Completion Date : October 31, 2029
Estimated Study Completion Date : October 31, 2029

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: Tarlatamab
Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
 Drug: Tarlatamab
Intravenous (IV) infusion
Other Name: AMG 757
Placebo Comparator: Placebo
Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
 Drug: Placebo
IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. PFS as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 6 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) Over the Whole Trial [ Time Frame: Up to approximately 6 years ]
  2. PFS Determined by Investigator Assessment [ Time Frame: Up to approximately 6 years ]
  3. Objective Response (OR) Rate [ Time Frame: Up to approximately 6 years ]
  4. Disease Control (DC) Rate [ Time Frame: Up to approximately 6 years ]
  5. Duration of Response (DOR) [ Time Frame: Up to approximately 6 years ]
  6. PFS at 6 months, 1 year, 2 years [ Time Frame: 6 months, 1 year, 2 years ]
  7. OS at 6 months, 1 year, 2 years, 3 years [ Time Frame: 6 months, 1 year, 2 years, 3 years ]
  8. Time to Progression (TTP) [ Time Frame: Up to approximately 6 years ]
  9. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 6 years ]
  10. Serum Concentration of Tarlatamab [ Time Frame: Up to approximately 4 months ]
  11. Incidence of Anti-tarlatamab Antibody Formation [ Time Frame: Up to approximately 1 year ]

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: -Participants are eligible to be included in the study only if all of the following criteria apply:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Histologically or cytologically confirmed small-cell lung cancer (SCLC).
  • Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
  • Has completed chemoradiotherapy without progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1.) (ie, achieved complete response [CR], partial response [PR], or stable disease [SD]).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Minimum life expectancy of 12 weeks.
  • Adequate organ function.
  • Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.

Exclusion Criteria: -Participants are excluded from the study if any of the following criteria apply:

Disease Related

  • Extensive-stage SCLC (ES-SCLC).
  • Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
  • History of other malignancy within the past 2 years, with certain exceptions.
  • History of solid organ transplantation.
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
  • Exclusion of human immunodeficiency virus (HIV) and hepatitis infection based on criteria per protocol.
  • 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 study treatment.

Prior/Concomitant Therapy

  • Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
  • Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
  • Prior history of severe or life-threatening events from any immune-mediated therapy.
  • Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
  • Major surgical procedures within 28 days prior to first dose of study treatment.
  • Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.

Prior/Concurrent Clinical Study Experience

• Treatment in an alternative investigational trial within 28 days prior to enrollment.

Other Exclusions

  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of study treatment.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of study treatment.
  • Female participants planning to become pregnant or donate eggs while on study through 72 days after the last dose of study treatment.
  • Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive 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 132 days after the last dose of study treatment.
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 132 days after the last dose of study treatment.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 days after the last dose of study treatment.
  • 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 (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
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): NCT06117774


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:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT06117774    
Other Study ID Numbers: 20230016
2023-506235-15 ( Other Identifier: EU CT Number )
First Posted: November 7, 2023    Key Record Dates
Last Update Posted: May 1, 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: 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:
Limited Stage Small Cell Lung Cancer
Small Cell Lung Cancer
LS SCLC
 SCLC
AMG 757
Tarlatamab
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
AMG 757
Antineoplastic Agents