Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Extensive Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tarlatamab

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fuzhou, China, 350011
    • Fujian Cancer Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400042
      • Army Special Medical Center of Peoples Liberation Army
    • Chongqing, Chongqing Municipality, China, 400037
      • The Second Affiliated Hospital of Army Medical University, People's Liberation Army
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
    • Jiangmen, Guangdong, China, 529000
      • Jiangmen Central Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Meidical University Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Linhai, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tarlatamab; Participants will receive tarlatamab as an intravenous (IV) infusions in 28-day cycles.	Drug: Tarlatamab; IV infusion; Other Names: AMG 757; IMDELLTRA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.	From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) Based on BICR Per RECIST 1.1	DOR was defined as time from the first documentation of OR until the first documentation of disease progression (PD) or death due to any cause, whichever occured first. Only participants who had achieved OR were evaluated for DOR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have reduction in short axis to <10 mm, NOT total disappearance. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.	Approximately 24 months
Disease Control (DC) Based on BICR Per RECIST 1.1	DC was defined as CR + PR + stable disease (SD). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrate an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.	Approximately 24 months
Duration of DC Based on BICR Per RECIST 1.1	Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD.	Approximately 24 months
Progression-free Survival (PFS) Based on BICR Per RECIST 1.1	PFS was defined as the time from first dose of tarlatamab until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.	Approximately 24 months
ORR Based on Investigator Assessment Per RECIST 1.1	ORR based on investigator assessment was defined as the percentage of participants with BOR of CR plus PR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters.	Approximately 24 months
DOR Based on Investigator Assessment Per RECIST 1.1	DOR was defined as time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first. Only participants who had achieved OR would be evaluated for DOR. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.	Approximately 24 months
DC Based on Investigator Assessment Per RECIST 1.1	DC was defined as CR + PR + SD. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.	Approximately 24 months
Duration of DC Based on Investigator Assessment Per RECIST 1.1	Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD.	Approximately24 months
PFS Based on Investigator Assessment Per RECIST 1.1	PFS was defined as time from enrollment until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.	Approximately 24 months
Overall Survival (OS)	OS was defined as time from the first dose of tarlatamab until death from any cause.	Approximately 24 months
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were defined as AEs starting on or after the first dose of tarlatamab up to the safety follow-up (SFU) visit or 60 days after the last dose of tarlatamab, whichever was later.	Approximately 24 months
Trough Concentration (Ctrough) of Tarlatamab	Ctrough of tarlatamab was calculated using standard noncompartmental methods.	Approximately 24 months
Number of Participants With Anti-tarlatamab Antibodies Formation	Number of participants with anti-tarlatamab (binding and neutralizing) antibodies was presented.	Approximately 24 months

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Estimated): January 8, 2027

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: China; Cancer; Pharmacokinetics; Platinum; Malignancy; Platinum-based; Tumor; Extensive Stage Small Cell Lung Cancer; SCLC; Neuroendocrine tumor; AMG 757; Tarlatamab; Chinese Participants; Bi-specific T-cell engager; Programmed Cell Death Ligand 1; Advanced Small Cell Lung Cancer; IMDELLTRA; Programmed Cell Death Protein 1; PD-1 Protein; PD-L1 Protein; BiTE molecule
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Neuroendocrine Tumors; Antineoplastic Agents; AMG 757
• Other Study ID Numbers: 20230273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes