Prospective International Observational Cohort Study Assessing Safety Outcomes Among Squamous Non-small Cell Lung Cancer Patients Treated with Necitumumab in Combination with Gemcitabine and Cisplatin in Comparison to Patients Treated with Cisplatin-based Doublets (I4X-MC-B002)

Study identification

• EU PAS number:
  EUPAS12595
• Study ID:
  29241
• Official title and acronym:
  Prospective International Observational Cohort Study Assessing Safety Outcomes Among Squamous Non-small Cell Lung Cancer Patients Treated with Necitumumab in Combination with Gemcitabine and Cisplatin in Comparison to Patients Treated with Cisplatin-based Doublets (I4X-MC-B002)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany
• Study description:
  To evaluate the safety of necitumumab administered in combination withgemcitabine and cisplatin in comparison to cisplatin doublets for treatment of adult patients with locally advanced or metastatic squamous non-small cell lung cancer who have not received prior chemotherapy for this condition; ; On 15-Feb-2021, the EU license for Portrazza (Necitumumab) expired in EU, and a decision was made by ; the Sponsor to terminate the non-interventional PASS B002 study.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 12/10/2016

Study start date

Planned: 28/02/2019

Actual: 11/03/2019

Date of final study report

Planned: 29/12/2023

Actual: 15/02/2021

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?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)