RELAY - Ramucirumab in Metastatic NSCLC (JVCY study)

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

• IRAS ID

  172859

• Contact name

  Sanjay Popat

• Contact email

  sanjay.popat@rmh.nhs.uk

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2014-004824-22

• Clinicaltrials.gov Identifier

  NCT02411448

• Duration of Study in the UK

  4 years, 10 months, 31 days

• Research summary

  The JVCY is a study of previously untreated patients with metastatic EGFR mutation-positive NSCLC. The study is divided into 2 parts: Phase 1b and Phase 3. The UK patients will be taking part in Phase 3 only.
  
  Part A - is Phase 1b, single-arm and open-label part which will assess the safety and tolerability of the recommended dose for the Phase 3 part, Part B (Ramucirumab 10 mg/kg every 2 weeks and Erlotinib 150 mg daily). The target enrollment is 12 patients. Patients will be enrolled in 1 of 2 cohorts (Cohort 1 will include 6 patients from Japan and Cohort 2 will include 6 patients from North America and/or Europe). Part A patients may be enrolled concurrently into selected cohorts.

  Part B - is Phase 3, randomised, double-blinded portion of the trial and will compare the efficacy and safety of Ramucirumab in combination with Erlotinib versus placebo in combination with Erlotinib. The dose will be selected based on the Phase 1b outcome. The patient randomisation will proceed after the completion of Part A DLT assessment. Approximately 450 patients will be randomised evenly between the 2 treatment arms, defined by all combinations of the following:
  • EGFR mutation (exon 19 deletion vs. exon 21 [L858R] substitution mutation)
  • Gender (male vs. female)
  • Region (East Asia vs. other)
  • EGFR testing method (Therascreen® [Qiagen] and Cobas® [Roche] vs. other PCR and sequencing-based methods)

  Treatment in Parts A (Ramucirumab plus Erlotinib) and B (Ramucirumab/placebo plus Erlotinib) will continue until disease progression, unacceptable toxicity, or another permitted reason for study discontinuation. The study treatment in this protocol is considered Ramucirumab or placebo in combination with Erlotinib, or any component of the combination.
  

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  15/LO/1487

• Date of REC Opinion

  20 Nov 2015

• REC opinion

  Further Information Favourable Opinion