Clinical trial NCT06502977: Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Official title: Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Extensive Stage Small Cell Lung Cancer
Advanced Small Cell Lung Cancer
SCLC
AMG 757
Tarlatamab
IMDELLTRA
Tumor
Programmed Cell Death Protein 1
Programmed Cell Death Ligand 1
PD-1 Protein
PD-L1 Protein
Pharmacokinetics
Malignancy
Cancer
Chinese Participants
China
Platinum
Platinum-based
Neuroendocrine tumor
Bi-specific T-cell engager
BiTE molecule
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).


Eligibility criteria: Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
* Histologically or cytologically confirmed small cell lung cancer.
* Extensive-stage SCLC participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-\[L\]1) and at least 1 other prior line of therapy.
* Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Minimum life expectancy of 12 weeks.
* Adequate organ function.

Exclusion Criteria:

Disease Related

* 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.
* Symptomatic central nervous system (CNS) metastases.
* Diagnosis or evidence of leptomeningeal disease.
* Prior history of severe or life-threatening events from any immune-mediated therapy.

Other Medical Conditions

* 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.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis.
* History of other malignancy within the past 2 years, with certain exceptions
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of study drug.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of study drug.
* Participants 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 drug.
* HIV, Hepatitis B, and Hepatitis C, with certain exceptions.
* Major surgery within 28 days of first dose study drug. Prior/Concomitant Therapy
* Currently or previously enrolled in a tarlatamab study.
* Prior therapy with any selective inhibitor of the DLL3 pathway.
* Prior anti-cancer therapy within 21 days prior to first dose of study treatment, with certain exceptions.
* Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug, with certain exceptions.
* Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study drug. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for mpox infection) within 3 days prior to first dose of study drug.

Prior/Concurrent Clinical Study Experience

• Currently receiving treatment in another investigational device or drug study, or less than 30 days 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 period of time after the last dose of study drug as specified in the study protocol.
* Female participants who are breastfeeding or who plan to breastfeed while on study and for an additional period of time after the last dose of study drug as specified in the study protocol.
* Female participants planning to become pregnant or donate eggs while on study and for an additional period of time after the last dose of study drug as specified in the study 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 and for an additional period of time after the last dose of study drug as specified in the study protocol.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
* Participants has known sensitivity to any of the products or components to be administered during dosing.
* Participants 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 that, in the opinion of the investigator or medical monitor if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: ORR Based on BICR per RECIST 1.1
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Duration of Response (DOR) Based on BICR per RECIST 1.1
timeFrame: Approximately 24 months
measure: Disease Control (DC) Based on BICR per RECIST 1.1
timeFrame: Approximately 24 months
measure: Duration of DC Based on BICR per RECIST 1.1
timeFrame: Approximately 24 months
measure: Progression-free Survival (PFS) Based on BICR per RECIST 1.1
timeFrame: Approximately 24 months
measure: ORR Based on Investigator Assessment per RECIST 1.1
timeFrame: Approximately 24 months
measure: DOR Based on Investigator Assessment per RECIST 1.1
timeFrame: Approximately 24 months
measure: DC Based on Investigator Assessment per RECIST 1.1
timeFrame: Approximately 24 months
measure: Duration of DC Based on Investigator Assessment per RECIST 1.1
timeFrame: Approximately 24 months
measure: PFS Based on Investigator Assessment per RECIST 1.1
timeFrame: Approximately 24 months
measure: Overall Survival (OS)
timeFrame: Approximately 24 months
measure: Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
timeFrame: Approximately 24 months
measure: Serum Concentration of Tarlatamab
timeFrame: Approximately 24 months
measure: Number of Participants with Anti-tarlatamab Antibody Formation
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University, People's Liberation Army
state: Chongqing
city: Chongqing
country: China
facility: Army Special Medical Center of Peoples Liberation Army
state: Chongqing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Meidical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: