GO43104 ATEZOLIZUMAB AND LURBINECTEDIN IN PATIENTS WITH ES-SCLC

• Research type

  Research Study

• Full 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

• IRAS ID

  1004257

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceuticals Division, PDR

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F.Hoffmann-La Roche Ltd

• Eudract number

  2021-001930-20

• Clinicaltrials.gov Identifier

  NCT05091567

• Research summary

  The purpose of this study is to assess the efficacy and safety of lurbinectedin, in combination with atezolizumab for the maintenance treatment of extensive-stage small-cell lung cancer (ES-SCLC) in participants whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide.
  Despite the improved efficacy observed with PD-L1 inhibitors in combination with platinum-based chemotherapy in first-line ES-SCLC, most patients eventually experience disease progression and upon relapse, their prognosis is poor. Therefore, novel combination
  strategies are needed to deliver better long-term outcomes. The study has two phases: an induction treatment phase, that last for 12 weeks and a maintenance treatment phase. In the induction phase of the study eligible participants will receive the approved standard treatment of carboplatin, etoposide and atezolizumab.
  In the maintenance treatment phase participants will be randomly assigned to either receive lurbinectedin with atezolizumab or atezolizumab alone.
  About 690 participants are expected to take part in the induction phase of this study. About 450 participants are expected to take part in the maintenance phase.
  To be eligible to take part in this study, participants must have been diagnosed with ES-SCLC and are treatment-naïve for their extensive-stage disease .

  The total length of the study, from screening of the first participant for the induction phase to the end of the study, is expected to be approximately 52 months.

  There will be approximately 27 patients recruited at 9 UK sites

  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version Number 2 and date 22/9/21

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  21/SC/0399

• Date of REC Opinion

  25 Jan 2022

• REC opinion

  Further Information Favourable Opinion