Small Cell Lung CancerNCT06064500
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
A study testing Tarlatamab in people with Small Cell Lung Cancer, run by Amgen at 23 sites in 4 countries.
Trial summary
The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Tarlatamab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 23 sitesin 4 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histologically or cytologically confirmed SCLC
- Extensive-stage, unable to be encompassed in a tolerable radiation plan
- Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
- Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
- Minimum life expectancy of 12 weeks
Who cannot join
- 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
- Symptomatic central nervous system (CNS) metastases
- Active hepatitis B or hepatitis C virus infection
- Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product
- Currently or previously enrolled in a prior tarlatamab study
- Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab
- Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States9 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22903
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Yale School of Medicine
New Haven, Connecticut, 06520
Perlmutter Cancer Center at New York University Langone Hospital - 34th Street
New York, New York, 10016
Nebraska Cancer Specialists
Omaha, Nebraska, 68106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Cancer Care Northwest - South
Spokane, Washington, 99202
Martin Memorial Health System
Stuart, Florida, 34994
Japan8 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Israel4 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah University Hospital-Ein Kerem
Jerusalem, 9112001
Assuta Medical Center
Petah Tikva, 4941492
Rabin Medical Center
Petah Tikva, 4941492
Brazil2 sites
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
About this study
Official title: A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen).
EA may still be available in countries outside of the United States.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Tarlatamab
- Keywords
- Lung cancer, Extensive-stage small cell lung cancer, Tarlatamab, AMG 757, Bispecific T-Cell Engager, BiTE, Immunotherapy, Immuno-oncology, Delta-like ligand 3
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Also called AMG 757
Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064500
- Sponsor's protocol ID
- 20220100
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
- ClinicalTrials.gov ID
- NCT06064500
- Acronym / sponsor ID
- 20220100
- Conditions
- Small Cell Lung Cancer
- Keywords
- Lung cancer, Extensive-stage small cell lung cancer, Tarlatamab, AMG 757, Bispecific T-Cell Engager, BiTE, Immunotherapy, Immuno-oncology
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen).
EA may still be available in countries outside of the United States.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Histologically or cytologically confirmed SCLC
- Extensive-stage, unable to be encompassed in a tolerable radiation plan
- Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
- Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
Key exclusion criteria (7 listed)
- 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
- Symptomatic central nervous system (CNS) metastases
- Active hepatitis B or hepatitis C virus infection
- Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product
- Currently or previously enrolled in a prior tarlatamab study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarlatamabAlso: AMG 757Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tarlatamab in people with Small Cell Lung Cancer, run by Amgen at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Japan, Israel, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.