Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-S… (NCT06117774) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
United States404 participantsStarted 2024-02-20
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 transplan…