Receive monthly emails about the latest oncology research and technology, new patient services, resources and more!

Please select an option below to help us tailor your newsletter to best suit your content interests!

No thanks
SCLC: EXTENSIVE STAGE: 1st Line: Atezo +/- lurbinectidin: IMforte

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab

Title
Roche GO43104 SCLC 1st line
Study Title

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab

Site Link
Malignancy
Small cell lung cancer, SCLC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st line maintenance
Investigational Agent
lurbinectidin
Drug Class
alkylating agent
PI
Jason Porter, MD
Sponsor
Hoffmann La Roche
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Eligibility for induction phase (Carbo etoposide)
    • Histologically or cytologically confirmed extensive stage SCLC
    • ECOG PS 0-1
    • No prior therapy for extensive stage disease
    • At least 6 monmths since chemo or XRT for earlier stage disease
    • Measurable disease
    • Negative for HIV and no known HBV/HCV
    • No CNS mets
    • No other malignancies within 5 years
  • Eligibilty for maintenance phase (atezolizumab +/- lurbinectidin)
    • Ongoing response or stable disease after 4 cycles of induction therapy
    • All toxicities attributed to prior induction therapy resolved to Grade
    • Not receiving consolidative chest radiation
    • Not receiving antibiotics at the time of randomization
Objective
  • Primary
    • PFS by independent review
    • OS
  • Secondary
    • PFS by investigator
    • ORR
    • DOR
    • Landmark PFS rates
    • Landmark OS rates
    • Safety
    • Time to deterioration
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
small cell lung carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X