Metastatic Non-Small Cell Lung CancerPhase 3RELAYNCT02411448
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
A Phase 3 study testing Ramucirumab, Erlotinib and Gefitinib in people with Metastatic Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 106 sites in 14 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Ramucirumab, Erlotinib and Gefitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 545 participants
- Where
- 106 sitesin 14 countries
- Study dates
- 6 May 2015to Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
106 sites in 14 countries.
106 sites in 14 countries
Japan41 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
Hyogo Prefectual Amagasaki General Medical Center
Amagashiki, Hyōgo, 660-8550
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku, Tokyo, 113-8677
Chiba University Hospital
Chiba, 260-8677
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Kyushu University Hospital
Fukuoka, 812-8582
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
Himeji Medical Center
Himeji, Hyōgo, 670-8520
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
Saitama Prefectural Cancer Center
Ina-machi, Saitama, 362-0806
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
National Cancer Center Hospital East
Kashiwa, Chiba, 277 8577
Kishiwada City Hospital
Kishiwada, Osaka, 596-8501
Foundation for Biomedical Research and innovation
Kobe, Hyōgo, 650-0047
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Kyoto University Hospital
Kyoto, 606-8507
Nagasaki University Hospital
Nagasaki, 852-8501
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-8777
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Niigata University Medical & Dental Hospital
Niigata, 951-8520
Okayama University Hospital
Okayama, 700-8558
Osaka City General Hospital
Osaka, 534-0021
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511
Osaka City University Hospital
Osaka, 545-8586
Kindai University Hospital- Osakasayama Campus
Ōsaka-sayama, Osaka, 589-8511
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Osaka, 5918555
Sendai Kousei Hospital
Sendai, Miyagi, 9800873
St. Lukes International Hospital
Tokyo, 104-8560
Juntendo University Hospital
Tokyo, 113-8431
Nippon Medical School Hospital
Tokyo, 113-8603
Ehime University Hospital
Tōon, Ehime, 791-0295
National Hospital Organization Yamaguchi Ube Medical Center
Ube, Yamaguchi, 755-0241
Wakayama MedicaL University Hospital
Wakayama, 641-0012
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
South Korea10 sites
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Gyeongsang National University Hospital
Jinju, Kyǒngsangnam-do, 52727
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 10408
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 08308
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, 16247
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033
Spain9 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, Barcelona [Barcelona], 08908
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Hospital Son Llatzer
Palma, Illes Balears [Islas Baleares], 07198
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario Virgen de Valme
Seville, 41014
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Taiwan8 sites
E-DA Hospital
Kaohsiung City, 82445
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
National Cheng-Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
MacKay Memorial Hospital
Taipei, 10449
Taipei Veterans General Hospital
Taipei, 11217
United States7 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
St. Charles Health System
Denver, Colorado, 80203
Queens Medical Associates
Fresh Meadows, New York, 11366
The Gastroenterology Group, P.C.
Honolulu, Hawaii, 96813
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Cancer Center of Kansas
Wichita, Kansas, 67214
Germany7 sites
Helios Klinikum Emil von Behring Berlin-Zehlendorf
Berlin, 14165
Klinikum Chemnitz GmbH
Chemnitz, Saxony, 09113
Klinikum Köln-Merheim
Cologne, North Rhine-Westphalia, 51109
Robert-Bosch-Krankenhaus
Gerlingen, Baden-Wurttemberg, 70839
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Saxony-Anhalt, 06120
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126
Italy6 sites
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081
Instituto Tumori Giovanni Paolo II
Bari, Apulia, 70124
IRCCS - AOU di Bologna
Bologna, 40138
Ospedale San Raffaele
Milan, 20132
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Torino, 10043
Istituto Oncologico Veneto IRCCS
Padova, 35128
France5 sites
Chu Grenoble Alpes
La Tronche, Isère, 38700
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59037
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, Hérault, 34090
Hôpital Européen Georges Pompidou
Paris, 75015
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021
Turkey (Türkiye)4 sites
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 1250
Ege Universitesi Hastanesi
Bornova, İzmir, 35100
Trakya University
Edirne, 22030
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, 44280
United Kingdom3 sites
Charing Cross Hospital
Chelsea, London, W6 8RF
Royal Marsden Hospital (Chelsea)
London, Kensington and Chelsea, SW3 6JJ
City Hospital, Nottingham University Hospitals
Nottingham, Nottinghamshire, NG5 1PB
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Queen Elizabeth Hospital
Yau Ma Tei, 999077
Romania2 sites
Institutul Oncologic
Bucharest, Bucharest, 022328
S.C. MedisProf SRL
Cluj-Napoca, Cluj, 400058
Greece1 site
Sotiria Thoracic Diseases Hospital of Athens
Athens, Attikí, 11527
About this study
Official 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
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.
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Being tested
- Ramucirumab, Placebo, Erlotinib, Gefitinib, Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
Also called LY3009806
Administered IV.
PlaceboDrug
Administered IV.
ErlotinibDrug
Administered orally.
GefitinibDrug
Administered orally.
OsimertinibDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab + Erlotinib | Experimental | Part 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. Receives: Drug: Ramucirumab; Drug: Erlotinib |
| Placebo + Erlotinib | Placebo comparator | Part 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. Receives: Drug: Placebo; Drug: Erlotinib |
| Ramucirumab + Gefitinib or Osimertinib | Experimental | Part 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. Receives: Drug: Ramucirumab; Drug: Gefitinib; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Cycle 1 Day 1 through End of Study (Up To 3 Years)
Secondary outcomes (10)
Part B: Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date).
Measured: 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])
ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. 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.
Measured: Randomization to Progressive Disease (Up To 37 Months)
Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. 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.
Measured: Randomization to Progressive Disease (Up To 37 Months)
Part B: Duration of Response (DoR)
DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. 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.
Measured: 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
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Measured: Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1
Part B: Number of Participants With Anti-Ramucirumab Antibodies
Part B: Number of Participants With Anti-Ramucirumab Antibodies.
Measured: Cycle 1 Predose through Follow-up (Up To 37 Months)
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome).
Measured: Baseline, End of Study (Up To 37 Months)
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Measured: Baseline, Cycle 10 (each cycle is 2 weeks)
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Measured: Baseline, Cycle 28 (each cycle is 2 weeks)
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
Measured: Baseline, Cycle 40 (each cycle is 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start6 May 2015
- Primary completion23 Jan 2019
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411448
- Sponsor's protocol ID
- 15540
- Other IDs
- I4T-MC-JVCY, 2014-004824-22, 2014
- Acronym
- RELAY
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2015
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40995949Nishio 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.
PubMed 40458541Nakagawa 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.
PubMed 39622410Nishio 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.
PubMed 37691865Garon 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.
PubMed 37390764Chiu 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.
PubMed 37329423Nakagawa 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.
PubMed 35841410Nishio 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.
PubMed 35369607Nadal 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.
PubMed 34928484Mitani 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.
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