Safety Profile of Pemetrexed+Carboplatin AUC5 and Pemetrexed+Carboplatin AUC6 for Patients with Non-Small Cell Lung Cancer (H3E-MC-B025)

Study identification

• EU PAS number:
  EUPAS9318
• Study ID:
  27980
• Official title and acronym:
  Safety Profile of Pemetrexed+Carboplatin AUC5 and Pemetrexed+Carboplatin AUC6 for Patients with Non-Small Cell Lung Cancer (H3E-MC-B025)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Pemetrexed in combination with carboplatin chemotherapy (Pem/Carbo) is widely recognized and endorsed by local and regional treatment guidelines used in clinical practice to treat patients with nonsquamous Non Small Cell Lung Cancer (NSCLC) in various countries around the world. There is a lack of information summarizing the safety profile of patients treated with this combination in real-world settings, which is in need by health care professionals. The purpose of this study is to evaluate the safety profiles of NSCLC patients treated with Pem/Carbo AUC5 and Pem/Carbo AUC6.A retrospective cohort study is proposed. The study will use information from a United States database that contains oncology clinics electronic medical records, combined with medical claims and pharmacy data, to assess the incidence of haematological and non-haematological safety outcomes among NSCLC patients treated with Pem/Carbo AUC5 relative to Pem/Carbo AUC6.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 20/11/2014

Actual: 06/04/2015

Study start date

Planned: 20/04/2015

Actual: 27/04/2015

Date of final study report

Planned: 31/12/2015

Actual: 05/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable