Phase Ib/II study with RO5083945 and chemotherapy in NSCLC patients

• Research type

  Research Study

• Full title

  A randomized, multicenter, open-label phase Ib/II study of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed versus cisplatin and gemcitabine/pemetrexed in patients with advanced or recurrent non small cell lung cancer who have not received prior chemotherapy

• IRAS ID

  50986

• Contact name

  James Spicer

• Sponsor organisation

  F. Hoffmann-La Roche

• Eudract number

  2010-018945-72

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a Phase Ib/II study with RO5083945 and chemotherapy in patients with advanced or recurrent non small cell lung cancer (NSCLC) who have not received prior chemotherapy. The trial is being conducted to learn if using a new anticancer drug called RO5083945 with standard chemotherapy, specifically cisplatin and gemcitabine, or cisplatin and pemetrexed, increases the time before the cancer progresses in patients with NSCLC. The study will also determine how often different side effects occur when using RO5083945 with cisplatin gemcitabine or cisplatin pemetrexed. The chemotherapy received by participants in this study will depend on the type of NSCLC they have. Squamous and adenocarcinoma are forms of lung cancer with different microscopic appearances. This study has two parts: Phase Ib and Phase II. In both parts of the study subjects will receive up to six 3-week cycles of either chemotherapy alone or in combination with RO5083945. Standard care in this situation is up to 6 cycles of chemotherapy alone. o Part I will assess the safety of two doses of RO5083945 with chemotherapy at the standard dose. o Part II will compare the safety and the time taken for disease to progress in patients given standard chemotherapy plus RO5083945 (Arm A) or standard chemotherapy alone (Arm B).The number of participating patients for Phase Ib is approximately 30-40 patients and for Phase II is approximately 120 patients (80 patients in Arm A and 40 patients in Arm B). The total number of patients in this study will be approximately 160. The total study duration will be approximately 23 months.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/61

• Date of REC Opinion

  2 Nov 2010

• REC opinion

  Further Information Favourable Opinion