A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
RELAY
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
3 other identifiers
interventional
545
14 countries
106
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B. The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2015
Longer than P75 for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedStudy Start
First participant enrolled
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2019
CompletedResults Posted
Study results publicly available
March 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 16, 2026
December 1, 2025
3.7 years
April 3, 2015
January 17, 2020
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Part B: Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)
Number of Participants With Treatment-Emergent Adverse Events
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Cycle 1 Day 1 through End of Study (Up To 3 Years)
Secondary Outcomes (10)
Part B: Overall Survival (OS)
Randomization to Date of Death from Any Cause (Up To 37 Months)
Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Randomization to Progressive Disease (Up To 37 Months)
Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
Randomization to Progressive Disease (Up To 37 Months)
Part B: Duration of Response (DoR)
Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months)
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1
- +5 more secondary outcomes
Study Arms (3)
Ramucirumab + Erlotinib
EXPERIMENTALPart A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Placebo + Erlotinib
PLACEBO COMPARATORPart B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Ramucirumab + Gefitinib or Osimertinib
EXPERIMENTALPart C: 10 mg/kg ramucirumab administered every 2 weeks intravenously (IV) + 250 mg Gefitinib or 80 mg Osimertinib daily orally. * Ramucirumab and gefitinib administered during period 1. * Ramucirumab and osimertinib administered during period 2.
Interventions
Administered IV.
Eligibility Criteria
You may qualify if:
- Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
- Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].
- Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
- At least one measurable lesion.
- Life expectancy of at least 3 months.
You may not qualify if:
- Known T790M EGFR mutation (not applicable for Part C Period 2).
- Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
- Serious illness or medical condition.
- Ongoing treatment with CYP3A4 inducers or strong inhibitors.
- Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
- History of gross hemoptysis.
- Significant bleeding disorders.
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- Radiographic evidence of intratumor cavitation.
- History of gastrointestinal perforation within last 6 months.
- History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
- History of any arterial thrombotic event within 6 months prior to enrollment.
- The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404, United States
St. Charles Health System
Denver, Colorado, 80203, United States
The Gastroenterology Group, P.C.
Honolulu, Hawaii, 96813, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Queens Medical Associates
Fresh Meadows, New York, 11366, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, 34090, France
Chu Grenoble Alpes
La Tronche, Isère, 38700, France
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59037, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Robert-Bosch-Krankenhaus
Gerlingen, Baden-Wurttemberg, 70839, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126, Germany
Klinikum Köln-Merheim
Cologne, North Rhine-Westphalia, 51109, Germany
Klinikum Chemnitz GmbH
Chemnitz, Saxony, 09113, Germany
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Saxony-Anhalt, 06120, Germany
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927, Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf
Berlin, 14165, Germany
Sotiria Thoracic Diseases Hospital of Athens
Athens, Attikí, 11527, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Yau Ma Tei, 999077, Hong Kong
Instituto Tumori Giovanni Paolo II
Bari, Apulia, 70124, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Torino, 10043, Italy
IRCCS - AOU di Bologna
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Oncologico Veneto IRCCS
Padua, 35128, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277 8577, Japan
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Hyogo Prefectual Amagasaki General Medical Center
Amagashiki, Hyōgo, 660-8550, Japan
Himeji Medical Center
Himeji, Hyōgo, 670-8520, Japan
Foundation for Biomedical Research and innovation
Kobe, Hyōgo, 650-0047, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 9800873, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kishiwada City Hospital
Kishiwada, Osaka, 596-8501, Japan
Kindai University Hospital- Osakasayama Campus
Ōsaka-sayama, Osaka, 589-8511, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Osaka, 5918555, Japan
Saitama Prefectural Cancer Center
Ina-machi, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-8777, Japan
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku, Tokyo, 113-8677, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Ube, Yamaguchi, 755-0241, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
St. Lukes International Hospital
Tokyo, 104-8560, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Nippon Medical School Hospital
Tokyo, 113-8603, Japan
Wakayama MedicaL University Hospital
Wakayama, 641-0012, Japan
Institutul Oncologic
Bucharest, București, 022328, Romania
S.C. MedisProf SRL
Cluj-Napoca, Cluj, 400058, Romania
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 10408, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
Gyeongsang National University Hospital
Jinju, Kyǒngsangnam-do, 52727, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 08308, South Korea
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, Barcelona [Barcelona], 08908, Spain
Hospital Son Llatzer
Palma, Illes Balears [Islas Baleares], 07198, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
E-DA Hospital
Kaohsiung City, 82445, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
MacKay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Ege Universitesi Hastanesi
Bornova, İzmir, 35100, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 1250, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, 44280, Turkey (Türkiye)
Royal Marsden Hospital (Chelsea)
London, Kensington and Chelsea, SW3 6JJ, United Kingdom
Charing Cross Hospital
Chelsea, London, W6 8RF, United Kingdom
City Hospital, Nottingham University Hospitals
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Related Publications (13)
Nishino K, Seto T, Nishio M, Nishio K, Kasahara K, Satouchi M, Yoh K, Hayashi H, Enatsu S, Matsui T, Varughese SC, Visseren-Grul C, Nakagawa K. RELAY: safety and efficacy of ramucirumab plus erlotinib in elderly Japanese patients with metastatic EGFR-mutated NSCLC. Future Oncol. 2025 Oct;21(24):3197-3206. doi: 10.1080/14796694.2025.2560225. Epub 2025 Sep 25.
PMID: 40995949DERIVEDNishio M, Seto T, Reck M, Garon EB, Nishio K, Kasahara K, Nishino K, Satouchi M, Yoh K, Hayashi H, Sakai K, Enatsu S, Frimodt-Moller B, Matsui T, Varughese SC, Carlsen M, Visseren-Grul C, Nakagawa K. Final Survival Outcomes With Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients With Untreated EGFR-Mutated Metastatic NSCLC: RELAY Japanese Subset. JTO Clin Res Rep. 2025 Feb 28;6(6):100819. doi: 10.1016/j.jtocrr.2025.100819. eCollection 2025 Jun.
PMID: 40458541DERIVEDNakagawa K, Garon EB, Seto T, Nishio M, Aix SP, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Nishino K, Yoh K, Shih JY, Chik JYK, Moro-Sibilot D, Puri T, Chacko Varughese S, Frimodt-Moller B, Visseren-Grul C, Reck M. RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC. J Thorac Oncol. 2025 Apr;20(4):487-499. doi: 10.1016/j.jtho.2024.11.032. Epub 2024 Nov 30.
PMID: 39622410DERIVEDNishio K, Sakai K, Nishio M, Seto T, Visseren-Grul C, Carlsen M, Matsui T, Enatsu S, Nakagawa K. Impact of ramucirumab plus erlotinib on circulating cell-free DNA from patients with untreated metastatic non-small cell lung cancer with EGFR-activating mutations (RELAY phase 3 randomized study). Transl Lung Cancer Res. 2023 Aug 30;12(8):1702-1716. doi: 10.21037/tlcr-22-736. Epub 2023 Aug 10.
PMID: 37691865DERIVEDGaron EB, Reck M, Nishio K, Heymach JV, Nishio M, Novello S, Paz-Ares L, Popat S, Aix SP, Graham H, Butts BD, Visseren-Grul C, Nakagawa K; RELAY study investigators. Ramucirumab plus erlotinib versus placebo plus erlotinib in previously untreated EGFR-mutated metastatic non-small-cell lung cancer (RELAY): exploratory analysis of next-generation sequencing results. ESMO Open. 2023 Aug;8(4):101580. doi: 10.1016/j.esmoop.2023.101580. Epub 2023 Jun 28.
PMID: 37390764DERIVEDChiu CH, Lin MC, Wei YF, Chang GC, Su WC, Hsia TC, Su J, Wang AK, Jen MH, Puri T, Shih JY. Efficacy and Tolerability of Ramucirumab Plus Erlotinib in Taiwanese Patients with Untreated, Epidermal Growth Factor Receptor-Mutated, Stage IV Non-small Cell Lung Cancer in the RELAY Study. Target Oncol. 2023 Jul;18(4):505-515. doi: 10.1007/s11523-023-00975-5. Epub 2023 Jun 17.
PMID: 37329423DERIVEDNakagawa K, Garon EB, Gao L, Callies S, Zimmermann A, Walgren R, Visseren-Grul C, Reck M. RELAY, ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small cell lung cancer: exposure-response relationship. Cancer Chemother Pharmacol. 2022 Aug;90(2):137-148. doi: 10.1007/s00280-022-04447-x. Epub 2022 Jul 16.
PMID: 35841410DERIVEDNishio M, Nishio K, Reck M, Garon EB, Imamura F, Kawaguchi T, Yamaguchi H, Ikeda S, Hirano K, Visseren-Grul C, Ceccarelli M, Wijayawardana SR, Zimmermann A, Matsui T, Enatsu S, Nakagawa K. RELAY+: Exploratory Study of Ramucirumab Plus Gefitinib in Untreated Patients With EGFR-Mutated Metastatic NSCLC. JTO Clin Res Rep. 2022 Feb 26;3(4):100303. doi: 10.1016/j.jtocrr.2022.100303. eCollection 2022 Apr.
PMID: 35369607DERIVEDNadal E, Horinouchi H, Shih JY, Nakagawa K, Reck M, Garon EB, Wei YF, Kollmeier J, Frimodt-Moller B, Barrett E, Lipkovich O, Visseren-Grul C, Novello S. RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability. Drug Saf. 2022 Jan;45(1):45-64. doi: 10.1007/s40264-021-01127-2. Epub 2021 Dec 20.
PMID: 34928484DERIVEDMitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.
PMID: 34795131DERIVEDNakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M; RELAY Study Investigators. 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 Dec;20(12):1655-1669. doi: 10.1016/S1470-2045(19)30634-5. Epub 2019 Oct 4.
PMID: 31591063DERIVEDReck M, Garon EB, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Kiura K, Widau RC, He S, Dalal R, Lee P, Nakagawa K. Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR-Mutant Metastatic Non-Small-Cell Lung Cancer (RELAY): Phase Ib Results. Clin Lung Cancer. 2018 May;19(3):213-220.e4. doi: 10.1016/j.cllc.2017.11.003. Epub 2017 Nov 21.
PMID: 29317191DERIVEDGaron EB, Reck M, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Lee P, Dalal R, Liu J, He S, Treat J, Nakagawa K. Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2017 Jan;18(1):96-99. doi: 10.1016/j.cllc.2016.05.023. Epub 2016 Jun 8.
PMID: 27894601DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2015
First Posted
April 8, 2015
Study Start
May 6, 2015
Primary Completion
January 23, 2019
Study Completion (Estimated)
December 1, 2026
Last Updated
January 16, 2026
Results First Posted
March 4, 2020
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.