Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer (NCT04607954) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer
United States29 participantsStarted 2020-12-04
Plain-language summary
This phase II trial studies the effects of durvalumab and lurbinectedin in treating patients with extensive stage small cell lung cancer that has come back (relapsed) or has not responded to previous treatment with chemotherapy and immunotherapy (refractory). Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Lurbinectedin is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving durvalumab and lurbinectedin may help kill more tumor cells and help patients live longer.
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:
* Age \>= 18 years
* Histological or cytological confirmation of small cell lung cancer
* Prior treatment requirements:
* Relapsed or progressed after only one prior chemotherapy and PD-1 or PD-L1 inhibitor regimen
* Prior therapy must have been an etoposide platinum doublet combined with PD-1 or PD-L1 inhibitor
* Group 1: Must have "platinum-sensitive" disease according to the following definitions:
* "Sensitive" disease: Relapse occurred \> 90 days after completion of prior therapy
* "Resistant" Disease: Relapse occurred =\< 90 days after completion of prior therapy
* Group 2: May have "platinum sensitive" (Group 2A) or "platinum resistant" (Group 2B) disease
* Measurable disease
* Body weight \> 30 kg
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 15 days prior to registration)
* Platelet count \>= 100,000/mm\^3 (obtained =\< 15 days prior to registration)
* Albumin \>= 2.5 mg/dL (obtained =\< 15 days prior to registration)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN if total bilirubin is \> 1.5 x ULN (obtained =\< 15 days prior to registration)
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 15 days prior to registration)
* Creatinine OR glo…
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.