Study of GDC-0941 for the treatment of non-small cell lung cancer

• Research type

  Research Study

• Full title

  A Phase II, Double-Blind, Placebo Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab with and without GDC-0941 in patients with Previously Untreated Advanced or Recurrent Non-Small Cell Lung Cancer

• IRAS ID

  95475

• Contact name

  Blackhall Fiona

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2011-002893-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Lung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancers and the prognosis of advanced NSCLC is particularly poor. Platinum-based combination chemotherapy (such as carboplatin and paclitaxel) is the standard first-line treatment. More recently, bevacizumab has been approved in combination with carboplatin and paclitaxel for advanced non-squamous NSCLC. Despite this, patients eventually become refractory to treatment. GDC-0941 blocks PI3-kinase (a protein that may be involved in the growth of some cancers). The purpose of this study is to investigate the effects of GDC-0941 on patients with advanced NSCLC when GDC-0941 is combined with other drugs for NSCLC treatment, compared to these other drugs alone. Patients with squamous NSCLC have an equal chance of being assigned to: - Arm A: GDC-0941 with carboplatin and paclitaxel - Arm B: placebo (dummy drug) with carboplatin and paclitaxel Patients with non-squamous NSCLC have an equal chance of being assigned to: - Arm C: GDC-0941 with carboplatin, paclitaxel and bevacizumab - Arm D: placebo with carboplatin, paclitaxel and bevacizumab GDC-0941/placebo tablets are taken once daily, 14 out of 21 days of the first 4 cycles, then continuously. Carboplatin and paclitaxel are given on Day 1 of the first 4 cycles. Bevacizumab (for non-squamous NSCLC) is given on Day 1 of each cycle. Patients will receive study treatment until disease progression, intolerable side effects, withdrawal of consent or study completion or discontinuation. After the first cycle, patients will visit the clinic on Day 1 of each cycle. Study procedures include physical examination, vital signs, ECG, CT / MRI scans, blood and urine samples. This study is sponsored by Genentech, Inc. approximately 302 patients will participate in this study in Europe, the US and other select countries, with approximately 9 patients from 3 hospitals in the UK.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  12/NE/0009

• Date of REC Opinion

  23 Feb 2012

• REC opinion

  Further Information Favourable Opinion