MARIPOSA-2: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of lazertinib, amivantamab, carboplatin, and pemetrexed (LACP) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP), respectively, in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. NSCLC accounts for approximately 85 percent (%) of lung cancers. Advanced NSCLC is a serious terminal illness that accounts for approximately 20% of all cancer mortality, and until recently had a median overall survival (OS) of approximately 1 year. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. It shows clinical activity against tumors with primary activating EGFR mutations Exon 19del and Exon 21 L858R substitution. Lazertinib (JNJ-73841937; YH-25448) is an oral, highly potent, third-generation EGFR tyrosine kinase inhibitor (TKI). It selectively inhibits both primary activating EGFR mutations (Exon 19del, Exon 21 L858R substitution) and the EGFR T790M resistance mutation, with less inhibition of wild-type EGFR. The study consists of a Screening Phase (up to 28 days), a Treatment Phase (from randomization until the End of Treatment visit) and a Follow-up Phase (from End of Treatment Visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first). Safety will be assessed by physical examinations, laboratory tests, vital signs, electrocardiograms, Eastern Cooperative Oncology Group (ECOG) performance status, and monitoring of adverse events (AEs). The total duration of the study is up to 48 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm A: LACP (Lazertinib, Amivantamab, Carboplatin, and Pemetrexed) Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as intravenous (IV) infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Lazertinib, Pemetrexed, and Amivantamab as maintenance until disease progression. |
Drug: Lazertinib
Lazertinib will be administered orally.
Other Names:
Drug: Amivantamab
Amivantamab will be administered as an IV infusion.
Other Names:
Drug: Pemetrexed
Pemetrexed will be administered as an IV infusion.
Drug: Carboplatin
Carboplatin will be administered as an IV infusion.
|
Active Comparator: Arm B: CP (Carboplatin and Pemetrexed) Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression. |
Drug: Pemetrexed
Pemetrexed will be administered as an IV infusion.
Drug: Carboplatin
Carboplatin will be administered as an IV infusion.
|
Experimental: Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed) Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression. |
Drug: Amivantamab
Amivantamab will be administered as an IV infusion.
Other Names:
Drug: Pemetrexed
Pemetrexed will be administered as an IV infusion.
Drug: Carboplatin
Carboplatin will be administered as an IV infusion.
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central Review (BICR) [Up to 17 months]
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary Outcome Measures
- Objective Response as Assessed by BICR [Up to 17 months]
Objective response is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as their best response as defined by BICR using RECIST v1.1 criteria.
- Overall Survival (OS) [Up to 48 months]
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
- Duration of Response (DoR) [Up to 17 months]
DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR.
- Time to Subsequent Therapy (TTST) [Up to 17 months]
TTST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death whichever comes first.
- Progression-Free Survival After First Subsequent Therapy (PFS2) [Up to 17 months]
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
- Time to Symptomatic Progression (TTSP) [Up to 17 months]
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.
- Intracranial PFS [Up to 17 months]
Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1.
- Number of Participants with Adverse Events (AEs) [Up to 48 months]
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Number of Participants with Clinical Laboratory Abnormalities [Up to 48 months]
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urinalysis) will be reported.
- Serum Concentration of Amivantamab [Up to 17 months]
Serum samples will be analyzed to determine concentrations of amivantamab.
- Plasma Concentration of Lazertinib [Up to 17 months]
Plasma samples will be analyzed to determine concentrations of lazertinib.
- Number of Participants with Anti-Amivantamab Antibodies [Up to 17 months]
Number of participants with anti-amivantamab antibodies will be reported.
- Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) [Up to 17 months]
NSCLC-SAQ is a 7-item PRO measure designed for use in adults to assess symptoms of advanced non-small cell lung cancer (NSCLC). The NSCLC-SAQ has a seven-day recall period. It contains five domains and accompanying items that will be identified as symptoms of NSCLC: cough (1 item), pain (2 items), dyspnea (1 item), fatigue (2 items), and appetite (1 item). Each item uses a response scale between 0 to 4, with higher scores indicating more severe symptomatology. All five of these domains must be non-missing to compute a total score, with a response range from 0 to 20 with higher scores indicating more severe symptomatology.
- European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score [Up to 17 months]
The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
- Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) [Up to 17 months]
PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being. Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
-
Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
-
A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
-
Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
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Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade <= 2 peripheral neuropathy, or Grade <= 2 hypothyroidism stable on hormone replacement)
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A woman of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
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Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)
Exclusion Criteria:
-
Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
-
Participant with symptomatic or progressive brain metastases
-
Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
-
Participant has known small cell transformation
-
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Carl T. Hayden Veterans Administration Medical Center | Phoenix | Arizona | United States | 85012 |
2 | City of Hope | Duarte | California | United States | 91010 |
3 | University Of California San Diego | La Jolla | California | United States | 92037 |
4 | Pacific Shores Medical Group in Long Beach | Long Beach | California | United States | 90813 |
5 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
6 | University of California, Irvine | Orange | California | United States | 92868 |
7 | St Joseph Heritage Healthcare | Santa Rosa | California | United States | 95403 |
8 | Yale Cancer Center | New Haven | Connecticut | United States | 06510 |
9 | Hartford Hospital | Plainville | Connecticut | United States | 06062 |
10 | University of Miami/Sylvester Cancer Center | Aventura | Florida | United States | 33180 |
11 | Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | United States | 33308 |
12 | University of Florida | Gainesville | Florida | United States | 32610 |
13 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
14 | University Cancer & Blood Center, LLC | Athens | Georgia | United States | 30607 |
15 | Pacific Health Research and Education Institute | Honolulu | Hawaii | United States | 96819 |
16 | Sinai Cancer Care | Chicago | Illinois | United States | 60608 |
17 | Cancer Care Specialists of Central Illinois | Decatur | Illinois | United States | 62526 |
18 | Indiana University | Indianapolis | Indiana | United States | 46202 |
19 | East Jefferson General Hospital | Metairie | Louisiana | United States | 70006 |
20 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
21 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
22 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
23 | Saint Louis University | Saint Louis | Missouri | United States | 63110 |
24 | Nebraska Cancer Specialists | Grand Island | Nebraska | United States | 68803 |
25 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
26 | VA Sierra Nevada Health Care System | Reno | Nevada | United States | 89502 |
27 | Astera Cancer Care | East Brunswick | New Jersey | United States | 08816 |
28 | North Shore-Long Island Jewish Health System | Lake Success | New York | United States | 11042 |
29 | Icahn School of Medicine at Mt. Sinai | New York | New York | United States | 10029 |
30 | TriHealth Network | Cincinnati | Ohio | United States | 45220 |
31 | Oklahoma Cancer Specialists and Research Institute, LLC | Tulsa | Oklahoma | United States | 74146 |
32 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
33 | Kaiser Permanente Northwest | Portland | Oregon | United States | 97227 |
34 | Alliance Cancer Specialists | Horsham | Pennsylvania | United States | 19044 |
35 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
36 | MUSC-Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
37 | Sanford Health | Sioux Falls | South Dakota | United States | 57117 |
38 | University of Tennessee Health Sciences Center | Memphis | Tennessee | United States | 38103 |
39 | Baptist Cancer Center | Memphis | Tennessee | United States | 38120 |
40 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
41 | Texas Oncology-Medical City Dallas | Dallas | Texas | United States | 75230 |
42 | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
43 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390 |
44 | Oncology Consultants - Texas | Houston | Texas | United States | 77030 |
45 | UT MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
46 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
47 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
48 | Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
49 | Blue Ridge Cancer Care | Wytheville | Virginia | United States | 24382 |
50 | NorthWest Medical Specialties, PLLC | Puyallup | Washington | United States | 98373 |
51 | IADT Instituto Argentino de Diagnostico y Tratamiento | Caba | Argentina | C1122 | |
52 | Centro Medico Fleischer | Caba | Argentina | C1414 | |
53 | CEMIC (Centro de Educación Médica e Investigaciones Clínicas) | Caba | Argentina | C1431FWO | |
54 | CINME - Centro de Investigaciones Metabolicas | Ciudad Autonoma de Buenos Aires | Argentina | C1027AAP | |
55 | Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | Argentina | 5000 | |
56 | Hospital Privado Universitario de Córdoba | Córdoba | Argentina | X5016KEH | |
57 | Hospital Privado de la Comunidad | Mar del Plata | Argentina | B7602CBM | |
58 | Centro de Investigaciones Clinicas-CIC-IESR | Rosario | Argentina | 2000 | |
59 | Clínica Viedma | Viedma | Argentina | R8500ACE | |
60 | Grand Hôpital de Charleroi, site Notre Dame | Charleroi | Belgium | 6000 | |
61 | UZA | Edegem | Belgium | 2650 | |
62 | UZ Gent | Gent | Belgium | 9000 | |
63 | Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | Belgium | 3500 | |
64 | UZ Leuven | Leuven | Belgium | 3000 | |
65 | CHU Sart-Tilman | Liege | Belgium | 4000 | |
66 | Clinique Saint Pierre | Ottignies | Belgium | 1340 | |
67 | Cetus Oncologia | Belo Horizonte | Brazil | 30110-017 | |
68 | CIONC - Centro Integrado de Oncologia de Curitiba | Curitiba | Brazil | 80810-050 | |
69 | Ynova Pesquisa Clinica | Florianopolis | Brazil | 88020-210 | |
70 | Fundação São Francisco Xavier | Ipatinga | Brazil | 35162 189 | |
71 | UPCO Unidade de Pesquisa Clinica em Oncologia | Pelotas | Brazil | 96020 080 | |
72 | Hospital Moinhos de Vento | Porto Alegre | Brazil | 90035-901 | |
73 | Hospital Ernesto Dornelles | Porto Alegre | Brazil | 90160-093 | |
74 | Oncoclínicas | Rio de Janeiro | Brazil | 22250-905 | |
75 | Instituto D'Or de Pesquisa e Ensino (IDOR) | Rio de Janeiro | Brazil | 22281-100 | |
76 | Instituto COI | Rio de Janeiro | Brazil | 22793080 | |
77 | Núcleo de Oncologia da Bahia | Salvador | Brazil | 40170-110 | |
78 | Hospital Sao Rafael | Salvador | Brazil | 41253-190 | |
79 | CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia | Santo André | Brazil | 09060-650 | |
80 | Fundação Antônio Prudente - A.C. Camargo Cancer Center | Sao Paulo | Brazil | 01509-010 | |
81 | IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Sorocaba | Brazil | 18030-005 | |
82 | Hospital Paulistano | São Paulo | Brazil | 01323-000 | |
83 | BP - Beneficencia Portuguesa de São Paulo | São Paulo | Brazil | 01323-001 | |
84 | Hospital Alemão Oswaldo Cruz | São Paulo | Brazil | 01327-001 | |
85 | Hospital Nove de Julho | São Paulo | Brazil | 01409902 | |
86 | Onco Star SP Oncologia Ltda | São Paulo | Brazil | 04543-000 | |
87 | Oncoclínicas | Uberlândia | Brazil | 38408-150 | |
88 | Multifunctional Hospital for Active Treatment 'Serdika' | Sofia | Bulgaria | 1303 | |
89 | Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' | Sofia | Bulgaria | 1407 | |
90 | Specialized Hospital for Active Treatment in Oncology | Sofia | Bulgaria | 1756 | |
91 | UMHAT Sofia Med | Sofia | Bulgaria | 1797 | |
92 | Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD | Varna | Bulgaria | 9010 | |
93 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
94 | British Columbia Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
95 | Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | Canada | M5G 1Z5 |
96 | McGill University Health Centre | Montreal | Quebec | Canada | H4A 3J1 |
97 | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China | 100021 | |
98 | Peking University People's Hospital | Beijing | China | 100044 | |
99 | Beijing Cancer Hospital | Beijing | China | 100142 | |
100 | Chinese PLA General Hospital | Beijing | China | 100853 | |
101 | Beijing Chest hospital, Capital medical university | Beijing | China | 101199 | |
102 | Hunan Cancer hospital | Changsha | China | 410013 | |
103 | The First People's Hospital Of Changzhou | Changzhou | China | 213003 | |
104 | Sichuan Cancer Hospital | Chengdu | China | 610041 | |
105 | West China Hospital, Sichuan University | Chengdu | China | 610041 | |
106 | Southwest Hospital | ChongQing | China | 400038 | |
107 | Chongqing University Cancer Hospital | Chongqing | China | ||
108 | The First Affiliated Hospital, Sun Yat-sen University | Guang Zhou | China | 510080 | |
109 | Sun Yat-Sen Memorial Hospital Sun Yat-sen University | Guangzhou | China | 510120 | |
110 | Zhejiang Cancer Hospital | Hang Zhou | China | 310022 | |
111 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | China | 310009 | |
112 | The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | China | 310009 | |
113 | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | China | 310016 | |
114 | Harbin medical university cancer hospital | Harbin | China | 150000 | |
115 | The First Affiliated hospital of Anliui Medical University | Hefei | China | 230022 | |
116 | Huizhou Municipal Central Hospital | Huizhou | China | 516001 | |
117 | Taizhou Hospital of Zhejiang Province | Linhai | China | 317000 | |
118 | Affiliated Hospital of North Sichuan Medical College | Nanchong | China | ||
119 | Ruijin Hospital, Shanghai Jiao Tong University | Shanghai | China | 200025 | |
120 | Fudan University Shanghai Cancer Center | Shanghai | China | 200032 | |
121 | Shanghai East Hospital | Shanghai | China | 310000 | |
122 | Shenzhen university General Hospital | Shenzhen | China | 518055 | |
123 | Cancer Hospital Chinese Academy of Medical Sciences | Shenzhen | China | 518116 | |
124 | Tianjin Medical University General Hospital | Tianjin | China | 300052 | |
125 | Weifang People's Hospital | Weifang | China | 261000 | |
126 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China | 710061 | |
127 | Yantai Yuhuangding Hospital | Yantai | China | 264000 | |
128 | Daping Hospital Army Characteristic Medical Center | Yuzhong District | China | 400042 | |
129 | Henan Cancer Hospital | Zhengzhou | China | 450008 | |
130 | Fakultni nemocnice Olomouc - I.P.Pavlova 6 | Olomouc | Czechia | 775 20 | |
131 | Vitkovicka nemocnice a.s. | Ostrava- Vitkovice | Czechia | 70300 | |
132 | Fakultni nemocnice Plzen | Plzen | Czechia | 30599 | |
133 | Aarhus Universitetshospital | Aarhus | Denmark | DK-8200 | |
134 | Rigshospitalet | Copenhagen | Denmark | DK-2100 | |
135 | Institut Sainte Catherine | Avignon Cedex 9 | France | 84918 | |
136 | Hospices Civils de Lyon HCL | Bron | France | 69500 | |
137 | CHU de Grenoble - Hôpital Albert Michallon | La Tronche | France | 38700 | |
138 | Centre Hospitalier Le Mans | le mans Cedex 9 | France | 72037 | |
139 | CHR Hôpital Calmette | Lille | France | 59000 | |
140 | Hopital Nord | Marseille Cedex 20 | France | 13915 | |
141 | CHU de Montpellier - Arnaud de Villeneuve | Montpellier Cedex 5 | France | 34295 | |
142 | Institut Curie | Paris | France | 75005 | |
143 | CHU Bordeaux | Pessac | France | 33604 | |
144 | CHRU Hôpital de Pontchaillou | Rennes | France | 35033 | |
145 | CHU Nantes | Sain-Herblain | France | 44800 | |
146 | Nouvel Hopital Civil - CHU Strasbourg | Strasbourg cedex | France | 67091 | |
147 | CHU Bretonneau | Tours | France | 37000 | |
148 | Evangelische Lungenklinik Berlin | Berlin | Germany | 13125 | |
149 | Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt am Main | Germany | 60590 | |
150 | Asklepios Klinikum Harburg | Hamburg | Germany | 21075 | |
151 | Thoraxklinik am Universitätsklinikum Heidelberg | Heidelberg | Germany | 69126 | |
152 | Onkologische Schwerpunktpraxis | Heilbronn | Germany | 74072 | |
153 | ViDia Christliche Kliniken Karlsruhe/St. Vincentius-Kliniken | Karlsruhe | Germany | 76135 | |
154 | POIS Sachsen GmbH iG | Leipzig | Germany | 04357 | |
155 | Bethanien Krankenhaus | Moers | Germany | 47441 | |
156 | Klinikum der Universität München | München | Germany | 80336 | |
157 | Pius-Hospital Oldenburg | Oldenburg | Germany | 26121 | |
158 | Oncologianova GmbH | Recklinghausen | Germany | 45659 | |
159 | Universitaetsklinikum Regensburg | Regensburg | Germany | 93053 | |
160 | Queen Mary Hospital | Hong Kong | Hong Kong | 999077 | |
161 | Health Care Global Enterprises pvt Ltd | Bangalore | India | 560027 | |
162 | Artemis Hospital | Gurugram | India | 122001 | |
163 | Tata Medical Center | Kolkata | India | 700160 | |
164 | Tata Memorial Hospital | Mumbai | India | 400012 | |
165 | Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst | Mumbai | India | 400053 | |
166 | Central India Cancer Research Institute | Nagpur | India | 440010 | |
167 | HCG Manavta Cancer Centre | Nasik | India | 422002 | |
168 | Action Cancer Hospital | New Delhi | India | 110063 | |
169 | Rajiv Gandhi Cancer Institute and Research Centre | New Delh | India | 110085 | |
170 | Noble Hospital Pvt Ltd | Pune | India | 411013 | |
171 | Bhaktivedanta Hospital & Research Institute | Thane | India | 411107 | |
172 | Soroka University Medical Center | Beersheba | Israel | 84101 | |
173 | Rambam Health Corporation | Haifa | Israel | 3109601 | |
174 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 | |
175 | Meir Medical Center | Kfar Saba | Israel | 44281 | |
176 | Rabin Medical Center | Petah Tikva | Israel | 49100 | |
177 | Chaim Sheba Medical Center | Ramat Gan | Israel | 5262100 | |
178 | Tel-Aviv Sourasky Medical Center | Tel-Aviv | Israel | 6423906 | |
179 | CRO, IRCCS, Istituto Nazionale Tumori | Aviano | Italy | 33081 | |
180 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Italy | 47014 | |
181 | Istituto Europeo di Oncologia | Milano | Italy | 20141 | |
182 | Azienda Ospedaliero-Universitaria Di Parma | Parma | Italy | 43126 | |
183 | Ospedale S. Maria Delle Croci | Ravenna | Italy | 48121 | |
184 | Istituto Nazionale Tumori Regina Elena | Roma | Italy | 00144 | |
185 | Policlinico G.B.Rossi | Verona | Italy | 37134 | |
186 | National Hospital Organization Shibukawa Medical Center | Gunma | Japan | 377-0280 | |
187 | Kobe City Medical Center General Hospital | Hyogo | Japan | 650-0047 | |
188 | Hyogo Cancer Center | Hyogo | Japan | 673-8558 | |
189 | Kanagawa Cancer Center | Kanagawa | Japan | 241-8515 | |
190 | Kurume University Hospital | Kurume | Japan | 830-0011 | |
191 | National Hospital Organization Nagoya Medical Center | Nagoya-shi | Japan | 460-0001 | |
192 | Niigata Cancer Center Hospital | Niigata | Japan | 951-8566 | |
193 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
194 | Shizuoka Cancer Center | Shizuoka | Japan | 411-8777 | |
195 | Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Tokyo | Japan | 113-8677 | |
196 | The Cancer Institute Hospital of JFCR | Tokyo | Japan | 135-8550 | |
197 | Ehime University Hospital | Toon-shi | Japan | 791-0295 | |
198 | Wakayama Medical University Hospital | Wakayama | Japan | 641-8510 | |
199 | National Hospital Organization Iwakuni Clinical Center | Yamaguchi | Japan | 740-8510 | |
200 | National Hospital Organization Yamaguchi Ube Medical Center | Yamaguchi | Japan | 755-0241 | |
201 | National Cancer Center | Gyeonggi-do | Korea, Republic of | 10408 | |
202 | CHA Bundang Medical Center, CHA University | Gyeonggi-do | Korea, Republic of | 13496 | |
203 | Seoul National University Bundang Hospital | Gyeonggi-do | Korea, Republic of | 13620 | |
204 | GyeongSang National University Hospital | Gyeongsangnam-do | Korea, Republic of | 52727 | |
205 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
206 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
207 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
208 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
209 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
210 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | ||
211 | Hospital Tengku Ampuan Afzan | Kuantan | Malaysia | 25100 | |
212 | Beacon Hospital Sdn. Bhd. | Petaling Jaya | Malaysia | 46050 | |
213 | Subang Jaya Medical Centre | Subang Jaya | Malaysia | 47500 | |
214 | Mount Miriam Cancer Hospital | Tanjung Bungah | Malaysia | 11200 | |
215 | Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Mexico | 44280 | |
216 | CIMOVA, Morals Vargas Centro de Investigación SC | Leon | Mexico | 37000 | |
217 | Health Pharma Professional Research | Mexico | Mexico | 03100 | |
218 | Instituto Nacional de Cancerologia | Mexico | Mexico | 14080 | |
219 | Oncologia Integral Satelite | Naucalpan | Mexico | 53100 | |
220 | NKI-AVL, Amsterdam | Amsterdam | Netherlands | 1066 CX | |
221 | VUMC Amsterdam | Amsterdam | Netherlands | 1081 HV | |
222 | Ziekenhuis St Jansdal | Harderwijk | Netherlands | 3844 DG | |
223 | Erasmus MC | Rotterdam | Netherlands | 3015 GD | |
224 | Centrum Onkologii im. Prof. F. Lukaszczyka | Bydgoszcz | Poland | 85-796 | |
225 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
226 | Szpitale Pomorskie Sp. z o.o. | Gdynia | Poland | 81-519 | |
227 | Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie | Olsztyn | Poland | 10-357 | |
228 | Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow | Poznan | Poland | 60-569 | |
229 | Private Specialist Hospitals - MedPolonia | Poznan | Poland | 60-693 | |
230 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warszawa | Poland | 02-781 | |
231 | Dolnoslaskie Centrum Onkologii | Wroclaw | Poland | 53-439 | |
232 | Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente | Lisboa | Portugal | 1769-001 | |
233 | Hospital Beatriz Angelo | Loures | Portugal | 2674-514 | |
234 | Centro Hospitalar Universitario do Porto, EPE | Porto | Portugal | 4099-001 | |
235 | Instituto Portugues de Oncologia | Porto | Portugal | 4200072 | |
236 | Pan American Center for Oncology Trials LLC | Rio Piedras | Puerto Rico | 00917 | |
237 | Krasnoyarsk Regional Oncology Dispensary | Krasnoyarsk | Russian Federation | 660133 | |
238 | LLC VitaMed | Moscow | Russian Federation | 121309 | |
239 | Central Clinical Hospital | Moscow | Russian Federation | 121359 | |
240 | Main Administration for Service to the Diplomatic Corps under the MoFA of the RF | Moscow | Russian Federation | 125284 | |
241 | Moscow City Oncology Hospital № 62 | Moskovskaya Oblast', Krasnogo | Russian Federation | 143423 | |
242 | City Clinical Hospital #1 | Nalchik | Russian Federation | 360000 | |
243 | Nizhny Novgorod Regional Oncological Dispensary | Nizhniy Novgorod | Russian Federation | 603000 | |
244 | Omsk Clinical Oncology Dispensary | Omsk | Russian Federation | 664013 | |
245 | Llc, Eurocityclinic | Saint Petersburg | Russian Federation | 197022 | |
246 | N.N. Petrov Research Institute Of Oncology | Saint Petersburg | Russian Federation | 197758 | |
247 | Oncology Medical Clinics AV Medical group | St-Petersburg | Russian Federation | 196006 | |
248 | Tambov Regional Oncology Clinical Dispansary | Tambov | Russian Federation | 392013 | |
249 | Tomsk Cancer Research Institute | Tomsk | Russian Federation | 634050 | |
250 | Multifunctional clinical medical center 'Medical city' | Tyumen | Russian Federation | 625041 | |
251 | Bashkir State Medical University | Ufa | Russian Federation | 450083 | |
252 | Hosp. Univ. A Coruña | A Coruña | Spain | 15006 | |
253 | Hosp. de La Santa Creu I Sant Pau | Barcelona | Spain | 08025 | |
254 | Hosp. Univ. Quiron Dexeus | Barcelona | Spain | 08028 | |
255 | Hosp. Univ. Vall D Hebron | Barcelona | Spain | 08035 | |
256 | Hosp. Clinic I Provincial de Barcelona | Barcelona | Spain | 08036 | |
257 | Hosp. Univ. Insular de Gran Canaria | Las Palmas de Gran Canaria | Spain | 35016 | |
258 | Hosp. Gral. Univ. Gregorio Marañon | Madrid | Spain | 28007 | |
259 | Hosp. Univ. Fund. Jimenez Diaz | Madrid | Spain | 28040 | |
260 | Hosp. Univ. 12 de Octubre | Madrid | Spain | 28041 | |
261 | Hosp. Univ. La Paz | Madrid | Spain | 28046 | |
262 | Hosp. Univ. Hm Sanchinarro | Madrid | Spain | 28050 | |
263 | Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | Spain | 28222 | |
264 | Hosp. Regional Univ. de Malaga | Málaga | Spain | 29010 | |
265 | Clinica Univ. de Navarra | Pamplona | Spain | 31008 | |
266 | Hosp. Virgen Del Rocio | Seville | Spain | 41013 | |
267 | Hosp. Gral. Univ. Valencia | Valencia | Spain | 46014 | |
268 | Hosp. Univ. I Politecni La Fe | Valencia | Spain | 46026 | |
269 | Sahlgrenska Universitetssjukhuset | Goteborg | Sweden | 413 45 | |
270 | Linkoping University Hospital | Linkoping | Sweden | 581 85 | |
271 | Skanes universitetssjukhus | Lund | Sweden | 221 85 | |
272 | Norrlands Universitetssjukhus | Umea | Sweden | 901 85 | |
273 | Akademiska Sjukhuset | Uppsala | Sweden | 75181 | |
274 | Changhua Christian Hospital | Changhua | Taiwan | 500 | |
275 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | 807 | |
276 | Taipei Medical University Shuang Ho Hospital | New Taipei City | Taiwan | 23561 | |
277 | Chung Shan Medical University Hospital | Taichung | Taiwan | 402 | |
278 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
279 | National Cheng Kung University Hospital | Tainan | Taiwan | 704 | |
280 | National Taiwan University Hospital | Taipei | Taiwan | 100 | |
281 | Adana City Hospital | Adana | Turkey | 01060 | |
282 | Memorial Ankara Hastanesi | Ankara | Turkey | 06520 | |
283 | Gazi University Hospital | Ankara | Turkey | 06560 | |
284 | Ankara Bilkent City Hospital | Ankara | Turkey | 06590 | |
285 | Trakya University Medical Faculty | Edirne | Turkey | 22030 | |
286 | Istanbul University Cerrahpasa Medical Faculty | Istanbul | Turkey | 34098 | |
287 | Bakirkoy Training and Research Hospital | Istanbul | Turkey | 34147 | |
288 | Medipol Mega University Hospital | Istanbul | Turkey | 34214 | |
289 | Acıbadem Maslak Hospital | Istanbul | Turkey | 34457 | |
290 | Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi | Istanbul | Turkey | 34722 | |
291 | Izmir Medical Park Hospital | Izmir | Turkey | 35575 | |
292 | Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2WG | |
293 | Birmingham Heartlands Hospital | Birmingham | United Kingdom | B9 5SS | |
294 | Velindre Hospital | Cardiff | United Kingdom | CF14 2TL | |
295 | Edinburgh Cancer Centre Western General | Edinburgh | United Kingdom | EH4 2XU | |
296 | Royal Surrey County Hospital NHS Trust | Guildford | United Kingdom | GU2 7XX | |
297 | Rutherford Cancer Centre North West | Liverpool | United Kingdom | L7 3EW | |
298 | Barts Heart Centre, St. Bartholomew's Hospital | London | United Kingdom | EC1A 7BE | |
299 | UCL Cancer Institute | London | United Kingdom | NW1 2PG | |
300 | Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | SE1 9RT | |
301 | The Royal Marsden NHS Trust | London | United Kingdom | SW3 6JJ | |
302 | The Christie Nhs Foundation Trust | Manchester | United Kingdom | M20 4BX | |
303 | Rutherford Cancer Centre South Wales | Newport | United Kingdom | NP10 8FZ | |
304 | Rutherford Cancer Centre Thames Valley | Reading | United Kingdom | RG2 9LH |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109061
- 2021-001825-33
- 61186372NSC3002