NCT07778316 Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)
| NCT ID | NCT07778316 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-08-28 |
| Primary Completion | 2027-09-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2026-08-28 with a primary completion date of 2027-09-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
Eligibility Criteria
Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent. * Histologically or cytologically confirmed SCLC with demonstrated progression or relapse. * Participants who progressed or recurred following 1 platinum-based regimen. * Measurable disease as defined per RECIST 1.1 within the 21-day screening period. * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. * Minimum life expectancy of 12 weeks. * Adequate organ function. * History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol. Exclusion Criteria: Disease Related \- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol. Other Medical Conditions * 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 (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment. * Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment. * History of other malignancy within the past 2 years, with exceptions defined in the protocol. * Presence or history of viral infection based on criteria per protocol. * History of solid organ transplantation. * Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment. * Known sensitivity or a contraindication to any of the products or components. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Prior/Concomitant Therapy * Prior systemic anticancer therapy within 30 days of enrolment * Prior history of severe or life-threatening events from any immune-mediated therapy. * Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment. * Live and live-attenuated vaccines within 28 days prior to the start of study treatment. * Receiving another anticancer therapy for a malignancy other than SCLC. * More than 1 prior line of anticancer therapy for SCLC. * Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway. * Treatment in an alternative investigational trial within 28 days prior to enrolment. * History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient. Other Exclusions * Participants unable to have SC injections administered in the abdomen or thigh. * Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements. * History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT07778316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07778316 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07778316 currently recruiting?
Yes, NCT07778316 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT07778316 trial being conducted?
This trial is being conducted at Orlando, United States, Grand Rapids, United States, Omaha, United States, Elizabeth Vale, Australia and 5 additional locations.
Who is sponsoring the NCT07778316 clinical trial?
NCT07778316 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 400 participants.
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