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
Who is this study for? Patients with previously untreated EGFR mutation-positive metastatic non-small cell lung cancer
What treatments are being studied? Ramucirumab+Erlotinib
Status: Active, not recruiting
Location: See all (110) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• 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.
Locations
United States
California
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles
UCLA Medical Center
Los Angeles
Colorado
Pharmatech Oncology Inc
Denver
Hawaii
The Queen's Medical Center
Honolulu
Kansas
Cancer Center of Kansas
Wichita
North Carolina
Levine Cancer Institute- Carolinas Medical Center
Charlotte
New York
Queens Medical Associates
Fresh Meadows
Oregon
St. Charles Health System
Bend
Pennsylvania
Allegheny General Hospital
Pittsburgh
Other Locations
Canada
Cross Cancer Institute
Edmonton
France
CHU Albert Michallon
Grenoble
CHRU de Lille-Hôpital Albert Calmette
Lille
Centre hospitalier universitaire Lapeyronie
Montpellier Cedex 5
APHP-Hôpital Européen Georges Pompidou
Paris
CHU la Miletrie
Poitiers
Germany
HELIOS Klinikum Emil von Behring
Berlin
Klinikum Chemnitz GmbH
Chemnitz
Klinik Schillerhöhe
Gerlingen
LungenClinic Grosshansdorf
Großhansdorf
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle (saale)
Thoraxklinik Heidelberg gGmbH
Heidelberg
Kliniken der Stadt Köln gGmbH Klinikum Köln-Merheim
Köln
Greece
SOTIRIA General Hospital
Athens
University General Hospital of Patras
Patras
Hong Kong Special Administrative Region
Queen Mary Hospital
Hong Kong
Queen Elizabeth Hospital
Kowloon
Italy
IRCCS Ospedale Oncologico di Bari
Bari
Policlinico S. Orsola Malpighi - Universita di Bologna
Bologna
IRCCS Ospedale San Raffaele
Milano
Azienda Ospedaliero - Universitaria S. Luigi Gonzaga
Orbassano
Istituto Oncologico Veneto
Padova
Azienda per l'Assistenza Sanitaria n°5 Friuli Occidentale
Pordenone
Japan
Hyogo Cancer Center
Akashi
Hyogo Prefectual Amagasaki General Medical Center
Amagashiki City
National Hospital Organization Asahikawa Medical Center
Asahikawa
Juntendo University Hospital
Bunkyo-ku
Nippon Medical School Hospital
Bunkyo-ku
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku
Chiba University Hospital
Chiba
National Cancer Center Hospital
Chuo-ku
St. Lukes International Hospital
Chuo-ku
Kyushu Cancer Center
Fukuoka
Kyushu University Hospital
Fukuoka
National Hospital Organization Kyushu Medical Center
Fukuoka
Osaka Habikino Medical Center
Habikino
National Hospital Organization Himeji Medical Center
Himeji
Kansai Medical University Hospital
Hirakata
Kanazawa University Hospital
Kanazawa
National Cancer Center Hospital East
Kashiwa
Kishiwada City Hospital
Kishiwada
Saitama Cancer Center
Kita-adachi
Foundation for Biomedical Research and innovation
Kobe
Kobe City Medical Center General Hospital
Kobe
The Cancer Institute Hospital of JFCR
Koto-ku
Kurume University Hospital
Kurume
Kyoto University Hospital
Kyoto
National Hospital Organization Shikoku Cancer Center
Matsuyama
Nagasaki University Hospital
Nagasaki
Aichi Cancer Center Hospital
Nagoya
Nagoya Medical Center
Nagoya
Niigata Cancer Center Hospital
Niigata
Niigata University Medical & Dental Hospital
Niigata
Okayama University Hospital
Okayama
Osaka City General Hospital
Osaka
Osaka City University Hospital
Osaka
Osaka International Cancer Institute
Osaka
Kindai University Hospital
Osaka Sayama-shi
National Hospital Organization Kinki-Chuo Chest Medical Cent
Sakai
Sendai Kousei Hospital
Sendai
Shizuoka Cancer Center
Sunto-gun
Yamaguchi-Ube Medical Center
Ube
Wakayama MedicaL University Hospital
Wakayama
Kanagawa Cancer Center
Yokohama
Kanagawa Cardiovascular and Respiratory Center
Yokohama
Republic of Korea
Chungbuk National University Hospital
Cheongju-si
Gyeong-Sang National University Hospital
Jin-ju-si
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Municipal Boramae Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
Asan Medical Center
Songpa-gu
Ajou University Hospital
Suwon
Saint Vincent Hospital
Suwon
Ulsan University Hospital
Ulsan
Romania
Institutul Oncologic Dr Trestioreanu Bucuresti
Bucuresti
S.C. MedisProf SRL
Cluj-napoca
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Institut Catala d'Oncologia
L'hospitalet De Llobregat
Hospital Universitario 12 de Octubre
Madrid
Hospital Fundacion Son Llatzer
Palma De Mallorca
Clinica Universitaria De Navarra
Pamplona
Hospital Universitario Quiron Madrid
Pozuelo De Alarcon
Hospital Universitario Nuestra Señora de Valme
Sevilla
Hospital Universitario Virgen del Rocio
Sevilla
Hospital Universitario La Fe de Valencia
Valencia
Taiwan
E-DA Hospital
Kaohsiung
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
Taichung Veterans General Hospital
Taichung
China Medical University Hospital
Taichung City
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
MacKay Memorial Hospital
Taipei City
National Taiwan University Hospital
Taipei City
Turkey
Baskent Adana Educational Hospital
Adana
Trakya University Faculty of Medicine
Edirne
Ege University Faculty of Medicine
Izmir
Inonu University Medical Faculty
Malatya
United Kingdom
Charing Cross Hospital
Chelsea
Royal Marsden NHS Trust
London
Nottingham City Hospital
Nottingham
Time Frame
Start Date: May 6, 2015
Estimated Completion Date: December 16, 2023
Participants
Target number of participants: 545
Treatments
Experimental: Ramucirumab + Erlotinib
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.
Placebo Comparator: Placebo + Erlotinib
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.
Experimental: Ramucirumab + Gefitinib or Osimertinib
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.
Authors
Jared Acoba, Heather Wakelee, Robert Boone, William Walsh, Edward Garon, Miriam Alonso Garcia, Winston Chua, Ahad Sadiq, Gabriel Jung, Moses Raj, Shaker Dakhil, Kathryn Mileham, Robert Dichmann, Yu-Feng Wei, Edgardo Santos, Gisela Martina Bohns Meyer, Keunchil Park, Giovanni Cagnotto, Felix Pavlotsky, Frederico Albrecht, SMO Pharmatech Oncology Inc, Michael Ziv, SMO TRIO -Translational Research, Saad Khan, Ki Hyeong Lee, Yael Anne Leshem, Gee-Chen Chang, Chao-Hua Chiu, Ernest Nadal, Jin-Yuan Shih, Sang-We Kim, Konstantinos N Syrigos, Konstantin Dragnev, Ernest Nadal Alforja, Óscar Juan Vidal, Santiago Ponce Aix, Ravindranath Patel, Haralabos Kalofonos, Belen Rubio Viqueira, Reiko Kaji, Silvia Novello
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company