Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topoteca… (NCT05153239) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
United States, Australia, Austria705 participantsStarted 2022-07-22
Plain-language summary
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
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
. Voluntary written informed consent of the patient obtained before any study-specific procedure
. Age≥18 years
. Histologically or cytologically confirmed diagnosis of SCLC.
. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
. Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
. Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
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.
1Since this Phase 3 trial has completed recruitment and is measuring overall survival as its main goal, has enough data come in yet for my doctor to know whether lurbinectedin actually helped people live longer compared to topotecan or irinotecan alone?
2This trial tested lurbinectedin both on its own and combined with irinotecan — given my specific situation with relapsed small-cell lung cancer, would my doctor think the single-agent approach or the combination would be more relevant to discuss?
3Because this is a Phase 3 trial comparing lurbinectedin against established treatments like topotecan, what does my doctor think about how the safety profile of lurbinectedin compares to what's already known about those standard options?
4Since this trial has completed enrollment, is there any published or preliminary data my doctor can share, and would it change the treatment path they'd recommend for me right now?
5Given that my cancer has already relapsed, how does my doctor weigh the option of waiting to see final results from this trial against starting one of the standard treatments — topotecan or irinotecan — that were used as comparators here?
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
Overall survival
Timeframe: From the date of randomization to the date of death or last contact, up to 39 months
. Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
. Adequate hematological, renal, metabolic and hepatic function:
Exclusion criteria
. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
. Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
. Active or untreated CNS metastases and/or carcinomatous meningitis.
. Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.
. Concomitant diseases/conditions:
. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.