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

Small Cell Lung Cancer Clinical Trial

— DeLLphi-306  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117774
• Other study ID #: 20230016
• Secondary ID: 2023-506235-15
• Status: Recruiting
• Phase: Phase 3
• Start date: February 20, 2024
• Est. completion date: October 31, 2029

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 31, 2029
• Est. primary completion date: October 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Limited Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Tarlatamab
Intravenous (IV) infusion
• Placebo
IV infusion

Locations

Country	Name	City	State
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
China	Shandong Provincial Cancer Hospital	Jinan	Shandong
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
Japan	Saitama Medical University International Medical Center	Hidaka-Shi	Saitama
Japan	Kansai Medical University Hospital	Hirakata-shi	Osaka
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-shi	Ehime
Japan	National Hospital Organization Nagoya Medical Center	Nagoya-shi	Aichi
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	Okayama University Hospital	Okayama-shi	Okayama
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo-shi	Hokkaido
Japan	Sendai Kousei Hospital	Sendai-shi	Miyagi
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center	Yokohama-shi	Kanagawa
Korea, Republic of	Chungbuk National University Hospital	Cheongju Chungbuk
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taipei Veterans General Hospital	Taipei
Turkey	Izmir Ekonomi Universitesi Medical Point Hastanesi	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Medical Park Seyhan Hastanesi	Mersin
United States	Our Lady of the Lake Cancer Institute	Baton Rouge	Louisiana
United States	West Virginia University Health Sciences Center	Morgantown	West Virginia
United States	FirstHealth Cancer Center	Pinehurst	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  China,  Japan,  Korea, Republic of,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS as Determined by Blinded Independent Central Review (BICR)		Up to approximately 6 years
Secondary	Overall Survival (OS) Over the Whole Trial		Up to approximately 6 years
Secondary	PFS Determined by Investigator Assessment		Up to approximately 6 years
Secondary	Objective Response (OR) Rate		Up to approximately 6 years
Secondary	Disease Control (DC) Rate		Up to approximately 6 years
Secondary	Duration of Response (DOR)		Up to approximately 6 years
Secondary	PFS at 6 months, 1 year, 2 years		6 months, 1 year, 2 years
Secondary	OS at 6 months, 1 year, 2 years, 3 years		6 months, 1 year, 2 years, 3 years
Secondary	Time to Progression (TTP)		Up to approximately 6 years
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Up to approximately 6 years
Secondary	Serum Concentration of Tarlatamab		Up to approximately 4 months
Secondary	Incidence of Anti-tarlatamab Antibody Formation		Up to approximately 1 year

External Links

•   AmgenTrials clinical trials website