Cyramza® (Ramucirumab)

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Ramucirumab: Enrollment by Country in RELAY

The RELAY study was conducted at 100 investigative sites in 13 different countries.

MX_cFAQ_RAM125_RELAY_STUDY_SITES
MX_cFAQ_RAM125_RELAY_STUDY_SITES
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Study Design

The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1

Enrollment by Country

The RELAY study was conducted at 100 investigative sites in 13 different countries. Geographic region was one of the stratification variables in the RELAY study.2 Patients were stratified to

  • East Asia
    • Hong Kong
    • Japan
    • South Korea
    • Taiwan, or
  • Other
    • Canada
    • France
    • Germany
    • United Kingdom
    • Spain
    • Italy
    • Romania
    • Turkey
    • United States.2

The enrollment of RELAY according to country is summarized in  .

Summary of Countries for Randomized Patients in the ITT3

Country

Ramucirumab + Erlotinib
(n=224)
n

Placebo + Erlotinib
(n=225)
n

Total
(N=449)
n

Canada

0

2

2

France

4

7

11

Germany

7

6

13

United Kingdom

4

3

7

Spain

23

19

42

Hong Kong

9

6

15

Italy

8

12

20

Japan

106

105

211

Korea

25

29

54

Romania

2

0

2

Taiwan

26

30

56

Turkey

3

4

7

United States

7

2

9

Abbreviation: ITT = intent-to-treat. 

References

1Nakagawa K, Garon E, Seto T, et al. RELAY: A multicenter, double-blind, randomized, phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). Presented as an oral presentation at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/173373/abstract

2Nakagawa K, Garon E, Seto T, et al. RELAY: A multicenter, double-blind, randomized, phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). Talk presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/173373/abstract

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

NSCLC = non-small cell lung cancer

PS = performance status

Fecha de la última revisión: 2019 M07 29


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