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Evaluating tarlatamab for limited-stage small-cell lung cancer after treatment

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

PHASE3 · Amgen · NCT06117774

This study is testing if tarlatamab can help people with limited-stage small-cell lung cancer live longer without their cancer getting worse after they finish chemoradiotherapy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorAmgen (industry)
Drugs / interventionschemotherapy, tarlatamab
Locations192 sites (Los Angeles, California and 191 other locations)
Trial IDNCT06117774 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of tarlatamab compared to a placebo in patients with limited-stage small-cell lung cancer (LS-SCLC) who have completed chemoradiotherapy. The primary measure of success will be progression-free survival (PFS), which indicates how long patients live without their cancer worsening. Participants must have a confirmed diagnosis of SCLC and meet specific health criteria to ensure they can safely receive the treatment. The study is designed to provide insights into the potential benefits of tarlatamab in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed LS-SCLC who have completed chemoradiotherapy without disease progression.

Not a fit: Patients with advanced-stage small-cell lung cancer or those who have not completed chemoradiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with limited-stage small-cell lung cancer.

How similar studies have performed: Previous studies have shown promise in using targeted therapies for small-cell lung cancer, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 191 other locations

+142 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer, LS SCLC, SCLC, AMG 757, Tarlatamab

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.