NCT06117774Active, not recruitingPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Amgen
- Enrollment
- 404
- Locations
- 358
- Primary Endpoint
- PFS as Determined by BICR
Study Overview
Brief Summary
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
- •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) or active 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.
Arms & Interventions
Tarlatamab
Experimental
Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).
Intervention: Tarlatamab (Drug)
Placebo
Placebo Comparator
Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
PFS as Determined by BICR
Time Frame: Up to approximately 6 years
OS Over the Whole Trial
Time Frame: Up to approximately 6 years
Secondary Outcomes
- PFS Determined by Investigator Assessment(Up to approximately 6 years)
- PFS at 6 months, 1 year, 2 years(6 months, 1 year, 2 years)
- OS at 6 months, 1 year, 2 years, 3 years(6 months, 1 year, 2 years, 3 years)
- Time to Progression (TTP)(Up to approximately 6 years)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 6 years)
- Serum Concentration of Tarlatamab(Up to approximately 4 months)
- Incidence of Anti-tarlatamab Antibody Formation(Up to approximately 1 year)
- Complete Response (CR) Rate(Up to approximately 6 years)
- CR + non-CR/non-Progressive Disease (PD) Rate(Up to approximately 6 years)
- Duration of Complete Response(Up to approximately 6 years)
- PFS Determined by Investigator Assessment(Up to approximately 6 years)
- Objective Response (OR) Rate(Up to approximately 6 years)
- Disease Control (DC) Rate(Up to approximately 6 years)
- Duration of Response (DOR)(Up to approximately 6 years)
- PFS at 6 months, 1 year, 2 years(6 months, 1 year, 2 years)
- OS at 6 months, 1 year, 2 years, 3 years(6 months, 1 year, 2 years, 3 years)
- Time to Progression (TTP)(Up to approximately 6 years)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 6 years)
- Serum Concentration of Tarlatamab(Up to approximately 4 months)
- Incidence of Anti-tarlatamab Antibody Formation(Up to approximately 1 year)
Investigators
Study Sites (358)
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