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 States, Argentina, Australia404 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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.