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

• ClinicalTrials.gov Identifier: NCT06117774
• Recruitment Status: Recruiting
• First Posted: November 7, 2023
• Last Update Posted: May 16, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: October 31, 2023
• First Posted Date: November 7, 2023
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: February 20, 2024
• Estimated Primary Completion Date: October 31, 2029 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 31, 2023): PFS as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 6 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 31, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
• 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
• Brief Summary: The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Limited Stage Small Cell Lung Cancer
• Small Cell Lung Cancer

Intervention

• Drug: Tarlatamab
  Intravenous (IV) infusion
  Other Name: AMG 757
• Drug: Placebo
  IV infusion

Study Arms

• 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).
  Intervention: Drug: Tarlatamab
• Placebo Comparator: Placebo
  Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 31, 2023): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2029
• Estimated Primary Completion Date: October 31, 2029 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China, Japan, Korea, Republic of, Taiwan, Turkey, United States
• Removed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, France, Germany, Greece, Hong Kong, Israel, Italy, Mexico, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

• NCT Number: NCT06117774
• Other Study ID Numbers: 20230016; 2023-506235-15 ( Other Identifier: EU CT Number )
• Has Data Monitoring Committee: Yes

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

• 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: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: May 2024