A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compa… (NCT05091567) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
United States, Belgium, Germany660 participantsStarted 2021-11-18
Plain-language summary
Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
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 for the Induction Phase:
* ECOG PS of 0 or 1
* No prior systemic therapy for ES-SCLC
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* Histologically or cytologically confirmed ES-SCLC
* Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
* Measurable disease, as defined by RECIST v1.1
* Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening
Exclusion Criteria for the Induction Phase:
* Presence or history of CNS metastases
* Active or history of autoimmune disease or deficiency
* History of malignancies other than SCLC within 5 years prior to enrollment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Treatment with investigational therapy within 28 days prior to enrollment
Inclusion Criteria for the Maintenance Phase:
* ECOG PS of 0 or 1
* Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
* Toxicities attributed to prior induction anti-cancer therapy or PCI re…
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.
1This trial is comparing lurbinectedin plus atezolizumab against atezolizumab alone as maintenance therapy after first-line treatment for extensive-stage small-cell lung cancer — is maintenance therapy even on the table for my situation, and how does this combination approach compare to what I'd receive as standard care?
2Since this is a Phase III trial, there should be more safety data available than in earlier phases — what side effects have been observed so far with this lurbinectedin and atezolizumab combination, and how might they affect my day-to-day life?
3The trial is active but no longer enrolling new participants — does that mean there's any chance I could still be considered, or are there related studies or the same drug combination available outside of a trial that we should look into?
4The trial is measuring both progression-free survival and overall survival as its main goals — based on what's known so far, is there any signal about whether this combination might offer a meaningful benefit over atezolizumab alone for someone with my specific disease profile?
5Given that this is a maintenance therapy study starting after initial chemotherapy, how would the timing and demands of participating in something like this fit with my current treatment plan and recovery, and is standard maintenance therapy an option I should consider first?
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.