Study of Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer
This study is looking at how well a drug called tarlatamab works compared to a placebo (an inactive substance) in people with limited-stage small-cell lung cancer. You might be able to join if you are 18 or older and have been diagnosed with this type of lung cancer. The main goals are to see if tarlatamab can help you live longer without the cancer getting worse (progression-free survival, or PFS) and if it helps you live longer overall (overall survival, or OS). These will be measured for up to about 6 years. The study is currently unclear on its recruitment status.
- Study design
- This study plans to enroll 404 participants. It compares tarlatamab given as an intravenous (IV) infusion to a placebo, also given as an IV infusion.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for progression-free survival and overall survival for up to approximately 6 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06117774
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatmentAmgen
~404 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:TarlatamabPlacebo
At a glance
Recruiting sites
0 of 204 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PFS as Determined by BICR
Measured over Up to approximately 6 years
+1 more outcome measured
Conditions
Where it's being run
204 sites across 94 statesTurkey (Türkiye)12
Italy10
South Korea10
Greece8
Poland8
Bulgaria7
Romania7
France5
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 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
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.
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.
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.
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.
What this trial measures
- PFS as Determined by BICRUp to approximately 6 years
- OS Over the Whole TrialUp to approximately 6 years