Clinical trial NCT06745323: A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC
Official title: A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Small Cell Lung Cancer (SCLC)
Keywords: Tarlatamab
AMG 757
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).


Eligibility criteria: Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
* Participants who progressed or recurred following 1 platinum-based regimen.
* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
* Minimum life expectancy of 12 weeks.
* Adequate organ function as described per protocol.

Exclusion Criteria:

* Disease Related

  * Previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC.
  * Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
* Other Medical Conditions

  * History of other malignancy within the past 2 years, with exceptions defined in the protocol.
  * Evidence of interstitial lung disease or active, non-infectious pneumonitis
  * Diagnosis or evidence of leptomeningeal disease.
  * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
  * 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
  * Presence or history of viral infection based on criteria per protocol.
  * Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
  * Known or active infection requiring parenteral antibiotic treatment.
  * History of severe or life-threatening events from any immune-mediated therapy.
  * Major surgical procedures within 21 days of prior to first dose of study treatment.
* Prior/Concomitant Therapy

  * Prior anticancer therapy within 30 days of enrollment (14 days for conventional chemotherapy).
  * Prior enrollment on a tarlatamab clinical trial OR prior therapy with any selective inhibitor of the DLL3 pathway.
  * Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
  * Receiving systemic corticosteroid therapy or any other immunosuppressive therapy within 7 days prior to first dose as described per protocol.
  * Live and live-attenuated vaccines within 14 days prior to the start of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
* Prior/Concurrent Clinical Study Experience

  * Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Other Exclusions

  * Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
  * Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
  * Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
  * 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 60 days after the last dose of tarlatamab.
  * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
  * Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
  * Participant has known sensitivity or is contraindicated 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, if consulted, would pose a risk to the subject safety or interfere with the study evaluation procedure or completion.

Primary outcomes:
measure: Proportion of participants with confirmed objective response to Tarlatamab
timeFrame: Approximately 52 Months
measure: Proportion of participants with complete response to Tarlatamab
timeFrame: Approximately 52 Months
measure: Proportion of participants with partial response to Tarlatamab
timeFrame: Approximately 52 Months
Secondary outcomes:
measure: Average serum concentrations of Tarlatamab
timeFrame: Approximately 52 Weeks
measure: Duration of confirmed response, defined as the time from the first documentation of OR until the first documentation of disease progression or death
timeFrame: Approximately 52 Months
measure: Disease control, defined as objective response or stable disease
timeFrame: Approximately 52 Months
measure: Duration of disease control
timeFrame: Approximately 52 Months
measure: Progression-free survival, defined as the time from randomization to the first documentation of disease progression or death due to any cause
timeFrame: Approximately 52 Months
measure: Objective response, defined as best overall response of CR or PR
timeFrame: Approximately 52 Months
measure: Overall survival, defined as the time from randomization to death due to any cause
timeFrame: Approximately 52 Months
measure: Overall Survival rate at 6 months and 1 year from randomization
timeFrame: Approximately 52 Months
measure: Number of participants with treatment-emergent adverse events
timeFrame: Approximately 52 Months
measure: Number of participants with anti-tarlatamab antibody formation
timeFrame: Approximately 52 Months
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Health Partners Cancer Center at Regions Hospital
state: Minnesota
city: Albany
country: United States
facility: New York Oncology Hematology PC
state: New York
city: Pinehurst
country: United States
facility: FirstHealth Cancer Center
state: North Carolina
city: Sayre
country: United States
facility: Guthrie Medical Group
state: Pennsylvania
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Respirar
state: Buenos Aires
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health, Austin Hospital
state: Victoria
city: Natal
country: Brazil
facility: Liga Norte-Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
state: Rio Grande Do Sul
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Harbin
country: China
facility: Affiliated Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Cheongju Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Hwasun-gun, Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
city: Istanbul
country: Turkey
facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: