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A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02411448
Recruitment Status : Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (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.


Condition or disease Intervention/treatment Phase
Metastatic Non-Small Cell Lung Cancer Drug: Ramucirumab Drug: Placebo Drug: Erlotinib Drug: Gefitinib Drug: Osimertinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 6, 2015
Actual Primary Completion Date : January 23, 2019
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Ramucirumab + Erlotinib

(Part A) 10 milligrams per kilogram (mg/kg) ramucirumab 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 every 2 weeks IV in combination with 150 mg erlotinib daily orally . Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Ramucirumab
Administered IV.
Other Name: LY3009806

Drug: Erlotinib
Administered orally.

Placebo Comparator: Placebo + Erlotinib

(Part A) Not Applicable

(Part B) Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Placebo
Administered IV.

Drug: Erlotinib
Administered orally.

Experimental: (Part C) Ramucirumab + Gefitinib or Osimertinib

(Period 1) Ramucirumab given IV and gefitinib given orally.

(Period 2) Ramucirumab given IV and osimertinib given orally.

Drug: Ramucirumab
Administered IV.
Other Name: LY3009806

Drug: Gefitinib
Administered orally.

Drug: Osimertinib
Administered orally.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 37 Months) ]
  2. Number of Participants with One or More Drug Related Adverse Events (AEs) or Any Serious AEs [ Time Frame: Cycle 1 Day 1 through End of Study (Estimated as 38 Months) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization to Date of Death from Any Cause (Estimated as 47 Months) ]
  2. Objective Response Rate (ORR) [ Time Frame: Randomization to Disease Progression (Estimated as 37 Months) ]
  3. Disease Control Rate (DCR) [ Time Frame: Randomization to Disease Progression (Estimated as 37 Months) ]
  4. Duration of Response (DoR) [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated as 37 Months) ]
  5. Pharmacokinetics (PK): Minimum Concentration (CMIN) of Ramucirumab [ Time Frame: Cycle 2 Predose through Cycle 14 Predose (Estimated as 28 Months) ]
  6. Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Cycle 1 Predose through Follow-up (Estimated as 38 Months) ]
  7. Change from Baseline on the Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline, End of Study (Estimated as 37 Months) ]
  8. Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, End of Study (Estimated as 37 Months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411448


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Locations
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United States, California
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, United States, 90024
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Colorado
Pharmatech Oncology Inc
Denver, Colorado, United States, 80203
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, New York
Queens Medical Associates
Fresh Meadows, New York, United States, 11366
United States, North Carolina
Levine Cancer Institute- Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
United States, Oregon
St. Charles Health System
Bend, Oregon, United States, 97701
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
France
CHU Albert Michallon
Grenoble, Cedex 9, France, 38049
CHRU de Lille-Hôpital Albert Calmette
Lille, France, 59037
Centre hospitalier universitaire Lapeyronie
Montpellier Cedex 5, France, 34295
APHP-Hôpital Européen Georges Pompidou
Paris, France, 75015
CHU la Miletrie
Poitiers, France, 86021
Germany
Klinik Schillerhöhe
Gerlingen, Baden-Württemberg, Germany, 70839
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Württemberg, Germany, 69126
Kliniken der Stadt Köln gGmbH Klinikum Köln-Merheim
Köln, Nordrhein-Westfalen, Germany, 51109
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Klinikum Chemnitz GmbH
Chemnitz, Sachsen, Germany, 09113
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, Germany, 22927
HELIOS Klinikum Emil von Behring
Berlin, Germany, 14165
Greece
University General Hospital of Patras
Patras, Achaia, Greece, 26504
SOTIRIA General Hospital
Athens, Greece, 11527
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Italy
Azienda per l'Assistenza Sanitaria n°5 "Friuli Occidentale"
Pordenone, PD, Italy, 33170
Azienda Ospedaliero - Universitaria S. Luigi Gonzaga
Orbassano, Torino, Italy, 10043
IRCCS Ospedale Oncologico di Bari
Bari, Italy, 70124
Policlinico S. Orsola Malpighi - Universita di Bologna
Bologna, Italy, 40138
IRCCS Ospedale San Raffaele
Milano, Italy, 20132
Istituto Oncologico Veneto
Padova, Italy, 35128
Japan
Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277 8577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan, 070-8644
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Hyogo Prefectual Amagasaki General Medical Center
Amagashiki City, Hyogo, Japan, 6608550
National Hospital Organization Himeji Medical Center
Himeji, Hyogo, Japan, 670-8520
Foundation for Biomedical Research and innovation
Kobe, Hyogo, Japan, 650-0047
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0047
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan, 236-0051
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 980-0873
Osaka Habikino Medical Center
Habikino, Osaka, Japan, 583-8588
Kansai Medical University Hospital
Hirakata, Osaka, Japan, 573-1191
Kishiwada City Hospital
Kishiwada, Osaka, Japan, 596-8501
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan, 589 8511
National Hospital Organization Kinki-Chuo Chest Medical Cent
Sakai, Osaka, Japan, 5918555
Saitama Cancer Center
Kita-Adachi, Saitama, Japan, 362-0806
Shizuoka Cancer Center
Sunto-Gun, Shizuoka, Japan, 411-8777
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8603
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku, Tokyo, Japan, 113-8677
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan, 104-8560
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Yamaguchi-Ube Medical Center
Ube, Yamaguchi, Japan, 755-0241
Chiba University Hospital
Chiba, Japan, 260-8677
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Kyoto University Hospital
Kyoto, Japan, 606-8507
Nagasaki University Hospital
Nagasaki, Japan, 852-8501
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Okayama University Hospital
Okayama, Japan, 700-8558
Osaka City General Hospital
Osaka, Japan, 534-0021
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Osaka City University Hospital
Osaka, Japan, 545-8586
Wakayama MedicaL University Hospital
Wakayama, Japan, 641-8510
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
Saint Vincent Hospital
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Gyeong-Sang National University Hospital
Jin-ju-si, Gyeongsangnam-do, Korea, Republic of, 52727
Samsung Medical Center
Seoul, Korea, Korea, Republic of, 06351
Korea University Guro Hospital
Seoul, Korea, Korea, Republic of, 08308
Ulsan University Hospital
Ulsan, Korea, Korea, Republic of, 44033
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 05505
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
Seoul Municipal Boramae Hospital
Seoul, Korea, Republic of, 07061
Romania
S.C. MedisProf SRL
Cluj-Napoca, Cluj, Romania, 400058
Institutul Oncologic Dr Trestioreanu Bucuresti
Bucuresti, Sector 2, Romania, 022328
Spain
Hospital Fundacion Son Llatzer
Palma de Mallorca, Baleares, Spain, 07198
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Quiron Madrid
Pozuelo de Alarcon, Madrid, Spain, 28223
Clinica Universitaria De Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario Nuestra Señora de Valme
Sevilla, Spain, 46014
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46026
Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, Taiwan, 83301
E-DA Hospital
Kaohsiung, Taiwan, 82445
China Medical University Hospital
Taichung City, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei City, Taiwan, 10048
MacKay Memorial Hospital
Taipei City, Taiwan, 10449
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Turkey
Baskent Adana Educational Hospital
Adana, Turkey, 1250
Trakya University Faculty of Medicine
Edirne, Turkey, 22770
Ege University Faculty of Medicine
Izmir, Turkey, 35100
Inonu University Medical Faculty
Malatya, Turkey, 44280
United Kingdom
Royal Marsden NHS Trust
London, Greater London, United Kingdom, SW3 6JJ
Charing Cross Hospital
Chelsea, London, United Kingdom, W6 8RF
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02411448     History of Changes
Other Study ID Numbers: 15540
I4T-MC-JVCY ( Other Identifier: Eli Lilly and Company )
2014-004824-22 ( EudraCT Number )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 1, 2019

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Gefitinib
Ramucirumab
Osimertinib
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs