Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (NCT07637513) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer
430 participantsStarted 2027-01
Plain-language summary
Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.
Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.
The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).
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.
* Patient must have histologically or cytologically confirmed Small Cell Lung Cancer (SCLC).
* SCLC must be diagnosed as Limited-Stage-SCLC (LS-SCLC) (Stage I-III, disease can be encompassed within a radical radiation portal per investigator assessment) and treated with 3 to 4 cycles of chemotherapy and radiation therapy. Three cycles of chemotherapy will be acceptable if the planned radiation therapy course is completed concurrently with chemotherapy.
* Patient must not be eligible for surgical resection or have had prior surgical resection for the current diagnosis of LS-SCLC.
* Small cell carcinoma may not be transformed from previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation). Mixed histology (aka combined small cell) histology tumors are permitted if the majority component is small cell histology.
* Chemotherapy must consist of a platinum agent (carboplatin or cisplatin) and etoposide.
* Definitive radiation may include daily treatment ≥ 60 gray (Gy) or twice-daily treatments 45 Gy or other biologically equivalent regimens given concurrently with chemotherapy.
* For early LS-SCLC (e.g., T1-2, N0, M0) without lymph node involvement, treatment with stereotactic ablative radiotherapy (SABR/SBRT) and chemotherapy is allowed.
* Prophylactic cranial radiation (PCI) is permitted but not required. If PCI is administered, 7 day wash-out period is required b…
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.
What they're measuring
1
This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).
Timeframe: From randomization until death due to any cause, assessed up to 131 months.
2
This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).
Timeframe: From randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.