Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cyramza® (ramucirumab): Registrering per land i RELAY

RELAY-studien genomfördes på 100 undersökningsplatser i 13 olika länder.

Detailed Information

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.1 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.1

The enrollment of RELAY according to country is summarized in Table 1.

Table 1. Summary of Countries for Randomized Patients in the ITT2

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

1. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

2. Data 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

Datum fӧr senaste ӧversyn 2019 M07 29


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss