BI1302.5 Study-BI695502 safety and efficacy in NS Cell Lung Cancer
Research type
Research Study
Full title
A multicenter, randomized, double-blind Phase III trial to evaluate efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced nonsquamous Non-Small Cell Lung Cancer
IRAS ID
186601
Contact name
Paul Taylor
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2014-002161-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 5 days
Research summary
Approximately 85% of all lung cancer deaths are attributed to patients having non–small cell lung cancer (NSCLC). A current treatment for the disease is the use of licensed biologic agent, Avastin®, which when used in conjunction with Chemotherapy has been shown to be effective in terms of benefit in overall response rate (ORR), Progression-free survival (PFS) and Overall Survival (OS). It is expensive however. The study test drug BI695502 is monoclonal antibody being developed as a cheaper alternative biosimilar to Avastin®. A Biosimilar is biological medicine which has similar properties in terms of quality, safety and efficacy to the already licensed product and this study aims to compare BI695502 with Avastin® against these criteria.
This Phase III study will assign approximately 660 patients worldwide, (330 per arm) to receive either BI695502 or Avastin®, plus chemotherapy according to a standard of care treatment schedule. This is a double-blinded trial (neither subject nor researcher knows which drug is being taken) in order to minimise any bias that any prior knowledge of the treatment could introduce.
Sunjects will first start 3 week induction cycles and receive treatment with 15 mg/kg of BI 695502 or Avastin® along with chemotherapy for up to 6 cycles. Patients who after 4 to 6 weeks show complete response (CR), partial response (PR) or stable disease (SD), will then receive maintenance treatment with their assigned drug as a single agent until either disease progression (according to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1]), death, withdrawal or unacceptable toxicity, whichever occurs earlier. All subjects who receive at least one infusion of BI 695502 or licensed Avastin® should return for a periodic End of Treatment (EOT) visit and a Safety Follow-up (SFU) visit once they have completed trial therapy and then will be monitored by telephone calls every 3 months.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0747
Date of REC Opinion
12 Nov 2015
REC opinion
Further Information Favourable Opinion