Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Jazz Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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 resolved to Grade \<=1
Adequate hematologic and end-organ function
You may not be if
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
Presence or history of CNS metastases
Receiving consolidative chest radiation
Severe infection within 2 weeks prior to randomization into the maintenance
Treatment with therapeutic oral or IV antibiotics at the time of randomization
