Trial Title:
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
NCT ID:
NCT06117774
Condition:
Limited Stage Small Cell Lung Cancer
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
AMG 757
Conditions: Keywords:
Limited Stage Small Cell Lung Cancer
Small Cell Lung Cancer
LS SCLC
SCLC
AMG 757
Tarlatamab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Tarlatamab
Description:
Intravenous (IV) infusion
Arm group label:
Tarlatamab
Other name:
AMG 757
Intervention type:
Drug
Intervention name:
Placebo
Description:
IV infusion
Arm group label:
Placebo
Summary:
The primary objective of this study is to compare the efficacy of tarlatamab with placebo
as assessed by progression free survival (PFS).
Criteria for eligibility:
Criteria:
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/or 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 60 days after the
last dose of study treatment.
- Female participants who are breastfeeding or who plan to breastfeed while on study
through 60 days after the last dose of study treatment.
- Female participants planning to become pregnant or donate eggs while on study
through 60 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 60 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 60 days after the last dose
of study treatment.
- Male participants unwilling to abstain from donating sperm during treatment and for
an additional 60 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Los Angeles
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Our Lady of the Lake Cancer Institute
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Einstein Center for Cancer Care
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Facility:
Name:
New York University Grossman School of Medicine and New York University Langone Hospitals
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Perlmutter Cancer Center at New York University Langone Hospital - Long Island
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
FirstHealth Cancer Center
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Facility:
Name:
Lehigh Valley Health Network
Address:
City:
Allentown
Zip:
18103
Country:
United States
Status:
Recruiting
Facility:
Name:
Spokenword Clinical Trials
Address:
City:
Easton
Zip:
18045
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Virginia Health System
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Facility:
Name:
West Virginia University Health Sciences Center
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Recruiting
Facility:
Name:
Fundacion Respirar
Address:
City:
Buenos Aires
Zip:
C1426ABP
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Port Macquarie Base Hospital
Address:
City:
Port Macquarie
Zip:
2444
Country:
Australia
Status:
Recruiting
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Fiona Stanley Hospital
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
Centro de pesquisa em oncologia Hospital Ana Nery
Address:
City:
Santa Cruz do Sul
Zip:
96835-090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Amaral Carvalho
Address:
City:
Jau
Zip:
17210-120
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Cepho
Address:
City:
Santo Andre
Zip:
09060-650
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Mengchao Hepatobiliary Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350025
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430060
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430070
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Northern Jiangsu Peoples hospital
Address:
City:
Yangzhou
Zip:
225009
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangxi Cancer hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Facility:
Name:
Qingdao Municipal Hospital
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030009
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
030032
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Urumqi
Zip:
830011
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Zip:
315016
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Taizhou Hospital
Address:
City:
Taizhou
Zip:
317099
Country:
China
Status:
Recruiting
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital / HKU
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Prince of Wales Hospital / CUHK
Address:
City:
Shatin, New Territories
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
National Hospital Organization Nagoya Medical Center
Address:
City:
Nagoya-shi
Zip:
460-0001
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama-shi
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kurume University Hospital
Address:
City:
Kurume-shi
Zip:
830-0011
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center
Address:
City:
Sapporo-shi
Zip:
003-0804
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Sendai-shi
Zip:
981-0914
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata-shi
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata-shi
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kindai University Hospital
Address:
City:
Osakasayama-shi
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Medical University International Medical Center
Address:
City:
Hidaka-Shi
Zip:
350-1298
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Cancer Center
Address:
City:
Kitaadachi-gun
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
Dokkyo Medical University Hospital
Address:
City:
Shimotsuga-gun
Zip:
321-0293
Country:
Japan
Status:
Recruiting
Facility:
Name:
Juntendo University Hospital
Address:
City:
Bunkyo-ku
Zip:
113-8431
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama
Zip:
641-8509
Country:
Japan
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju Chungbuk
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Gachon University Gil Hospital
Address:
City:
Incheon
Zip:
405-760
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si, Gyeonggi-do
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Icon - Mount Alvernia
Address:
City:
Singapore
Zip:
217562
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Universitaetsspital Basel
Address:
City:
Basel
Zip:
4052
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Ospedale Regionale di Bellinzona e Vali
Address:
City:
Mendrisio
Zip:
6850
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Ankara Bilkent Sehir Hastanesi
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Bagcilar Medipol Mega Universite Hastanesi
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Marmara Universitesi Tip Fakultesi Hastanesi
Address:
City:
Istanbul
Zip:
34890
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Izmir Ekonomi Universitesi Medical Point Hastanesi
Address:
City:
Izmir
Zip:
35575
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Kocaeli Universitesi Tip Fakultesi Hastanesi
Address:
City:
Kocaeli
Zip:
41380
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Medical Park Seyhan Hastanesi
Address:
City:
Mersin
Zip:
33200
Country:
Turkey
Status:
Recruiting
Start date:
February 20, 2024
Completion date:
October 31, 2029
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117774
http://www.amgentrials.com
