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Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

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ClinicalTrials.gov Identifier: NCT06211036
Recruitment Status : Not yet recruiting
First Posted : January 18, 2024
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

Condition or disease Intervention/treatment Phase
Extensive-Stage Small-Cell Lung Cancer Small-Cell Lung Cancer Drug: Tarlatamab Drug: Durvalumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Estimated Study Start Date : June 27, 2024
Estimated Primary Completion Date : September 27, 2027
Estimated Study Completion Date : September 25, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Tarlatamab in Combination With Durvalumab
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Drug: Tarlatamab
Intravenous (IV) infusion
Other Name: AMG 757

Drug: Durvalumab
IV infusion

Active Comparator: Durvalumab Alone
Participants will receive durvalumab Q4W alone.
Drug: Durvalumab
IV infusion




Primary Outcome Measures :
  1. OS [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
  2. Overall Response (OR) [ Time Frame: Up to approximately 3 years ]
  3. Disease Control (DC) Rate [ Time Frame: Up to approximately 3 years ]
  4. Duration of Response (DoR) [ Time Frame: Up to approximately 3 years ]
  5. PFS at 6 Months [ Time Frame: 6 months ]
  6. PFS at 1 Year [ Time Frame: 1 year ]
  7. PFS at 2 Years [ Time Frame: 2 years ]
  8. OS at 6 Months [ Time Frame: 6 months ]
  9. OS at 1 Year [ Time Frame: 1 year ]
  10. OS at 2 Years [ Time Frame: 2 years ]
  11. OS at 3 Years [ Time Frame: 3 years ]
  12. Time to Progression (TTP) [ Time Frame: Up to approximately 3 years ]
  13. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 9 months ]
  14. Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. [ Time Frame: Up to approximately 3 years ]
  15. Number of Participants with Serious TEAEs [ Time Frame: Up to approximately 3 years ]
  16. Number of Participants with TEAEs Leading to Discontinuation of Treatment [ Time Frame: Up to approximately 3 years ]
  17. Number of Participants with Fatal TEAEs [ Time Frame: Up to approximately 3 years ]
  18. Number of Participants with Treatment-related Adverse Events (AEs) [ Time Frame: Up to approximately 9 months ]
  19. Number of Participants with Adverse Events of Interest (EOI) [ Time Frame: Up to approximately 9 months ]
  20. Serum Concentrations of Tarlatamab [ Time Frame: Day 1 up to approximately 6 months ]
  21. Number of Participants with Antitarlatamab Antibody Formation [ Time Frame: Up to approximately 9 months ]
  22. Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30) [ Time Frame: Up to approximately 9 months ]
  23. Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13 [ Time Frame: Up to 12 months ]
  24. Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13 [ Time Frame: Up to 12 months ]
  25. Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13 [ Time Frame: Up to 12 months ]
  26. TTD for Global Health Status as Measured by EORTC-QLQ-C30 [ Time Frame: Up to approximately 9 months ]
  27. TTD for Quality of Life as Measured by EORTC-QLQ-C30 [ Time Frame: Up to approximately 9 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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age >= 18 years (or >= legal adult age within the country if it is older than 18 years).
  • Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
  • Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
  • Minimum life expectancy > 12 weeks.
  • Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue.
  • Adequate organ function

Exclusion

  • Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol
  • Prior history of severe or life-threatening events from any immune-mediated therapy. • History of other malignancy withing the past 2 years, with some exceptions as per protocol.
  • Active or prior documented autoimmune or inflammatory disorders as per protocol
  • Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment.
  • History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
  • Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
  • History of solid organ transplant.
  • Major surgical procedures within 28 days of first dose of study treatment.
  • Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
  • Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment:
  • History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide.
  • 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.
  • 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.
  • Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment.
  • Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
  • Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
  • Treatment in an alternative investigational trial within 28 days prior to enrollment.
  • Has received or is planning to receive consolidative chest radiation for extensive stage disease.
  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol
  • Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol
  • Female participants planning to become pregnant or donate eggs while on study as per protocol
  • 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 as per protocol
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol
  • Male participants unwilling to abstain from donating sperm during treatment as per protocol
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • Participant has known sensitivity to any of the products or components to be administered during dosing.
  • Participant likely not to be available to complete all protocol-required study visits or procedures to the best of the participant and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

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): NCT06211036


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: NCT06211036    
Other Study ID Numbers: 20200041
2023-505989-29 ( EudraCT Number )
First Posted: January 18, 2024    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 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:
Extensive-Stage Small-Cell Lung Cancer
ES-SCLC
Platinum
Etoposide
Durvalumab
Tarlatamab
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
Durvalumab
AMG 757
Antineoplastic Agents, Immunological
Antineoplastic Agents