Phase 1b Study of Necitumumab with Pembrolizumab in Advanced NSCLC

• Research type

  Research Study

• Full title

  Protocol I4X-MC-JFCQ A Single-Arm, Multicenter, Phase 1b Study with an Expansion Cohort to Evaluate Safety and Efficacy of the Combination of Necitumumab with Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer (NSCLC)

• IRAS ID

  190552

• Contact name

  Héléne Carmelez

• Contact email

  carmelez_helene@network.lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2015-001291-22

• Duration of Study in the UK

  3 years, 1 months, 19 days

• Research summary

  I4X-MC-JFCQ is a single-arm, multicenter Phase 1b study with an expansion cohort to investigate necitumumab in combination with pembrolizumab . The study consists of 2 parts:
  Part A Dose-escalation part with increasing doses of necitumumab to determine a recommended dose range for necitumumab that may be safely administered in combination with a fixed regimen of pembrolizumab in patients with Stage IV NSCLC
  Part B (expansion cohort)Dose confirmation of necitumumab in combination with a fixed regimen of pembrolizumab and exploration of clinical antitumor activity

  Patients will be treated until progressive disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. Patients who are on study therapy at study completion may continue to receive study therapy in the continued access period until they meet the discontinuation criteria.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  16/SC/0036

• Date of REC Opinion

  25 Feb 2016

• REC opinion

  Further Information Favourable Opinion