Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pembrolizumab+Lenvatinib Participants receive pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab will be administered for up to 35 treatment cycles (~2 years). Lenvantinib will be administered until progressive disease or unacceptable toxicity. |
Biological: Pembrolizumab
IV infusion of pembrolizumab at 200 mg
Other Names:
Drug: Lenvatinib
Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.
Other Names:
|
| Active Comparator: Docetaxel Participants receive docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel will be administered until progressive disease or unacceptable toxicity. |
Drug: Docetaxel
IV infusion of docetaxel at 75 mg/m^2.
Other Names:
|
| Experimental: Lenvatinib Monotherapy Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity. |
Drug: Lenvatinib
Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) [Up to ~48 months]
OS is defined as the time from randomization to the date of death due to any cause.
- Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Up to ~36 months]
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS will be assessed by blinded independent central review (BICR) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Secondary Outcome Measures
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel [Up to ~18 months]
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR will be assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy [Up to ~36 months]
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR will be assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Up to ~48 months]
DOR is defined as the time from first documented evidence of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) until disease progression or death due to any cause, whichever occurs first. DOR will be assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
- Number of Participants Experiencing an Adverse Event (AE) [Up to ~48 months]
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
- Number of Participants Discontinuing Study Treatment Due to an AE [Up to ~48 months]
The number of participants who discontinue study treatment due to an AE will be presented.
- Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score [Baseline and Week 12]
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of cancer patients, including a combined global health status (GHS)/QoL (Items 29 and 30) scale. For each item, scores range from 0-100, with higher scores indicating higher GHS/QoL. Per protocol, scores for items 29 and 30 will be averaged to compute a combined GHS/QoL scale score. Change from baseline in the combined GHS/QoL scale score will be presented.
- Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score [Baseline and Week 12]
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough (Item 31) scale score will be presented.
- Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score [Baseline and Week 12]
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain (Item 40) scale score will be presented.
- Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [Baseline and Week 12]
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). For this item, individual responses to the question "Were you short of breath?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea (Item 8) scale score will be presented.
- Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score [Baseline and Week 12]
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The PF scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Overall PF scores range from 0 to 100, with a lower score indicating a better outcome. The change from Baseline in the EORTC QLQ-C30 PF (Items 1 to 5) scale combined score will be presented.
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score [Up to ~48 months]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. The TTD in the combined GHS/QoL (Items 29 & 30) scale combined score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
- Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score [Up to ~48 months]
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). The TTD in EORTC QLQ-LC13 cough (Item 31) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
- Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score [Up to ~48 months]
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). The TTD in EORTC QLQ-LC13 chest pain (Item 40) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [Up to ~48 months]
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). The TTD in dyspnea (Item 8) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score [Up to ~48 months]
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The TTD in PF (Items 1 to 5) scale combined score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c).
-
Has PD on treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
-
Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
-
Has PD during/after platinum doublet chemotherapy for metastatic disease.
-
Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation).
-
Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor.
-
Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1, as determined by the local site assessment.
-
Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PD-L1], from the primary lesion or a metastatic lesion).
-
Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated.
-
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization.
-
Has a life expectancy of at least 3 months.
-
Male participants receiving pembrolizumab ± lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for ≥180 days after the last dose of study treatment.
-
Female participants must not be pregnant, not be breastfeeding, and not be a woman of child-bearing potential (WOCBP). If a WOCBP, agrees to not donate eggs and either use contraception, or be abstinent from heterosexual intercourse during the treatment period and for ≥120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last. If a WOCBP receiving docetaxel, agrees to adhere to the same conditions during the treatment period and for ≥180 days after the last dose of study treatment.
-
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization.
-
If participant received major surgery or radiation therapy of >30 Gy, they have recovered from the toxicity and/or complications from the intervention.
-
Has adequate organ function.
Exclusion Criteria:
-
Has received docetaxel as monotherapy or in combination with other therapies.
-
Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb.
-
Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy >30 Gy within 6 months before the first dose of study treatment.
-
Has received a live vaccine within 30 days before the first dose of study treatment.
-
Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment.
-
Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.
-
Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment.
-
Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment.
-
Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
-
Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment.
-
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
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Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
-
Has known active central nervous system metastases and/or carcinomatous meningitis.
-
Has severe hypersensitivity to pembrolizumab and/or any of its excipients.
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Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel.
-
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
-
Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
-
Has an active infection requiring systemic therapy.
-
Has a known history of human immunodeficiency virus (HIV) infection.
-
Has a known history of hepatitis B reactive or known active hepatitis C virus infection.
-
Has active tuberculosis.
-
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
-
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 180 days after the last dose of docetaxel.
-
Has had an allogeneic tissue/solid organ transplant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604) | Bakersfield | California | United States | 93309 |
| 2 | Cancer Specialists of North Florida - Fleming Island ( Site 1675) | Fleming Island | Florida | United States | 32003 |
| 3 | Mid-Florida Cancer Centers ( Site 1611) | Orange City | Florida | United States | 32763 |
| 4 | University of Kentucky School of Medicine & Hospitals ( Site 1621) | Lexington | Kentucky | United States | 40536 |
| 5 | Hematology Oncology Clinic ( Site 1680) | Baton Rouge | Louisiana | United States | 70809 |
| 6 | Harry & Jeanette Weinberg Cancer Institute ( Site 1626) | Baltimore | Maryland | United States | 21237 |
| 7 | Medstar Good Samaritan Hospital ( Site 1625) | Baltimore | Maryland | United States | 21239 |
| 8 | Massachusetts General Hospital ( Site 1622) | Boston | Massachusetts | United States | 02114 |
| 9 | MGH - North Shore Cancer Center ( Site 1668) | Danvers | Massachusetts | United States | 01923 |
| 10 | The Mass General Cancer Center at Newton-Wellesley ( Site 1692) | Newton | Massachusetts | United States | 02462 |
| 11 | University of Massachusetts Medical School ( Site 1693) | Worcester | Massachusetts | United States | 01655 |
| 12 | Billings Clinic ( Site 1631) | Billings | Montana | United States | 59101 |
| 13 | Bozeman Health Deaconness Cancer Center ( Site 1632) | Bozeman | Montana | United States | 59715 |
| 14 | Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664) | Basking Ridge | New Jersey | United States | 07920 |
| 15 | Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665) | Middletown | New Jersey | United States | 07748 |
| 16 | Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667) | Montvale | New Jersey | United States | 07645 |
| 17 | Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662) | Commack | New York | United States | 11725 |
| 18 | Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666) | Harrison | New York | United States | 10604 |
| 19 | Memorial Sloan-Kettering Cancer Center ( Site 1661) | New York | New York | United States | 10065 |
| 20 | New York Cancer and Blood Specialists ( Site 1696) | Port Jefferson Station | New York | United States | 11776 |
| 21 | University of Rochester ( Site 1638) | Rochester | New York | United States | 14642 |
| 22 | Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670) | Uniondale | New York | United States | 11553 |
| 23 | TriHealth Cancer Institute ( Site 1672) | Cincinnati | Ohio | United States | 45220 |
| 24 | MetroHealth Medical Center ( Site 1694) | Cleveland | Ohio | United States | 44109 |
| 25 | Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644) | Portland | Oregon | United States | 97227 |
| 26 | Fox Chase Cancer Center ( Site 1647) | Philadelphia | Pennsylvania | United States | 19111 |
| 27 | Thompson Cancer Survival Center ( Site 1695) | Knoxville | Tennessee | United States | 37916 |
| 28 | Millenium Physicians ( Site 1690) | Houston | Texas | United States | 77090 |
| 29 | Instituto de Investigaciones Metabolicas ( Site 2004) | Caba | Buenos Aires | Argentina | C1012AAR |
| 30 | Hospital Britanico de Buenos Aires ( Site 2002) | Buenos Aires | Caba | Argentina | C1280AEB |
| 31 | Sanatorio Parque ( Site 2005) | Rosario | Santa Fe | Argentina | S2000DSV |
| 32 | Hospital Aleman ( Site 2000) | Buenos Aires | Argentina | C1118AAT | |
| 33 | CEMIC ( Site 2003) | Buenos Aires | Argentina | C1431FWO | |
| 34 | Blacktown Hospital ( Site 0004) | Blacktown | New South Wales | Australia | 2148 |
| 35 | Port Macquarie Base Hospital ( Site 0003) | Port Macquarie | New South Wales | Australia | 2444 |
| 36 | Westmead Hospital ( Site 0005) | Westmead | New South Wales | Australia | 2145 |
| 37 | Southern Medical Day Care Centre ( Site 0001) | Wollongong | New South Wales | Australia | 2500 |
| 38 | Princess Alexandra Hospital - Division of Cancer Services ( Site 0002) | Woolloongabba | Queensland | Australia | 4102 |
| 39 | Calvary Central Districts Hospital ( Site 0007) | Elizabeth Vale | South Australia | Australia | 5112 |
| 40 | Bendigo Cancer Centre ( Site 0008) | Bendigo | Victoria | Australia | 3552 |
| 41 | CancerCare Manitoba ( Site 1504) | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 42 | Kingston Health Sciences Centre ( Site 1503) | Kingston | Ontario | Canada | K7L 2V7 |
| 43 | London Regional Cancer Program - London HSC ( Site 1505) | London | Ontario | Canada | N6A 5W9 |
| 44 | Princess Margaret Cancer Centre ( Site 1502) | Toronto | Ontario | Canada | M5G 2M9 |
| 45 | CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501) | Montreal | Quebec | Canada | H3T 1M5 |
| 46 | CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514) | Quebec | Canada | G1R 2J6 | |
| 47 | Rodrigo Botero SAS ( Site 1300) | Medellin | Antioquia | Colombia | 050030 |
| 48 | Clinica de la Costa Ltda. ( Site 1309) | Barranquilla | Atlantico | Colombia | 080020 |
| 49 | Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305) | Valledupar | Cesar | Colombia | 200001 |
| 50 | Oncomedica S.A. ( Site 1302) | Monteria | Cordoba | Colombia | 230001 |
| 51 | Administradora Country SA - Clinica del Country ( Site 1307) | Bogota | Distrito Capital De Bogota | Colombia | 110221 |
| 52 | Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304) | Bogota | Distrito Capital De Bogota | Colombia | 110311 |
| 53 | Centro Medico Imbanaco de Cali S.A ( Site 1301) | Cali | Valle Del Cauca | Colombia | 760042 |
| 54 | CHU Caen Service de Pneumologie ( Site 0401) | Caen | Calvados | France | 14033 |
| 55 | HIA Percy-Clamart ( Site 0411) | Clamart | Hauts-de-Seine | France | 92140 |
| 56 | ICO Centre Paul Papin ( Site 0412) | Angers | Maine-et-Loire | France | 49100 |
| 57 | Clinique Ambroise Pare ( Site 0402) | Beuvry | Pas-de-Calais | France | 62660 |
| 58 | Centre Hospitalier General - Avignon ( Site 0407) | Avignon | Provence-Alpes-Cote-d Azur | France | 84000 |
| 59 | Centre Hospitalier Le Mans ( Site 0406) | Le Mans | Sarthe | France | 72037 |
| 60 | Institut Curie ( Site 0400) | Paris | France | 75005 | |
| 61 | Hopital Europeen Georges Pompidou ( Site 0408) | Paris | France | 75015 | |
| 62 | Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501) | Heidelberg | Baden-Wurttemberg | Germany | 69126 |
| 63 | Evangelisches Krankenhaus Hamm gGmbH ( Site 0504) | Hamm | Nordrhein-Westfalen | Germany | 59063 |
| 64 | SRH Wald-Klinikum Gera GmbH ( Site 0503) | Gera | Thuringen | Germany | 07548 |
| 65 | Vivantes Klinikum Spandau ( Site 0505) | Berlin | Germany | 13585 | |
| 66 | General Hospital of Chest Diseases "Sotiria" ( Site 1703) | Athens | Attiki | Greece | 115 27 |
| 67 | Metropolitan Hospital-4th Oncology Dept ( Site 1700) | Athens | Attiki | Greece | 185 47 |
| 68 | University Hospital of Ioannina ( Site 1701) | Ioannina | Greece | 455 00 | |
| 69 | European Interbalkan Medical Center ( Site 1704) | Thessaloniki | Greece | 570 01 | |
| 70 | Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601) | Miskolc | Borsod-Abauj-Zemplen | Hungary | 3526 |
| 71 | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606) | Szekesfehervar | Fejer | Hungary | 8000 |
| 72 | Petz Aladar Megyei Oktato Korhaz ( Site 0609) | Gyor | Gyor-Moson-Sopron | Hungary | 9024 |
| 73 | Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610) | Szolnok | Jasz-Nagykun-Szolnok | Hungary | 5004 |
| 74 | Tudogyogyintezet Torokbalint ( Site 0602) | Torokbalint | Pest | Hungary | 2045 |
| 75 | Veszprem Megyei Tudogyogyintezet ( Site 0607) | Farkasgyepu | Veszprem | Hungary | 8582 |
| 76 | Semmelweis Egyetem.. ( Site 0604) | Budapest | Hungary | 1083 | |
| 77 | Orszagos Koranyi Pulmonologiai Intezet ( Site 0603) | Budapest | Hungary | 1121 | |
| 78 | Orszagos Koranyi Pulmonologiai Intezet ( Site 0608) | Budapest | Hungary | 1121 | |
| 79 | Soroka Medical Center ( Site 0701) | Beer Sheva | Israel | 8410101 | |
| 80 | Rambam Medical Center ( Site 0703) | Haifa | Israel | 3525408 | |
| 81 | Shaare Zedek Medical Center-Oncology ( Site 0706) | Jerusalem | Israel | 9013102 | |
| 82 | Meir Medical Center ( Site 0702) | Kfar-Saba | Israel | 4428132 | |
| 83 | Rabin Medical Center ( Site 0700) | Petah Tikva | Israel | 4941492 | |
| 84 | Chaim Sheba Medical Center ( Site 0704) | Ramat Gan | Israel | 5262000 | |
| 85 | Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705) | Tel Aviv | Israel | 6423906 | |
| 86 | Ospedale San Gerardo - ASST Monza ( Site 0804) | Monza | Monza E Brianza | Italy | 20900 |
| 87 | Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807) | Rome | Roma | Italy | 00144 |
| 88 | A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810) | Palermo | Sicilia | Italy | 90146 |
| 89 | Ospedale San Luigi Gonzaga ( Site 0802) | Orbassano | Torino | Italy | 10043 |
| 90 | Azienda Ospedaliera San Giuseppe Moscati ( Site 0809) | Avellino | Italy | 83100 | |
| 91 | IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808) | Bari | Italy | 70124 | |
| 92 | AOU Policlinico Vittorio Emanuele ( Site 0811) | Catania | Italy | 95123 | |
| 93 | Istituto Nazionale dei Tumori ( Site 0806) | Milano | Italy | 20133 | |
| 94 | Policlinico San Matteo - Fondazione IRCCS ( Site 0812) | Pavia | Italy | 27100 | |
| 95 | Azienda Ospedaliera di Perugia ( Site 0805) | Perugia | Italy | 06132 | |
| 96 | Kanagawa Cardiovascular and Respiratory Center ( Site 0105) | Yokohama | Kanagawa | Japan | 236-0051 |
| 97 | Sendai Kousei Hospital ( Site 0107) | Sendai | Miyagi | Japan | 980-0873 |
| 98 | Kansai Medical University Hospital ( Site 0104) | Hirakata | Osaka | Japan | 573-1191 |
| 99 | Chiba University Hospital ( Site 0106) | Chiba | Japan | 260-8677 | |
| 100 | Niigata Cancer Center Hospital ( Site 0101) | Niigata | Japan | 951-8566 | |
| 101 | National Cancer Center Hospital ( Site 0103) | Tokyo | Japan | 104-0045 | |
| 102 | The Cancer Institute Hospital of JFCR ( Site 0100) | Tokyo | Japan | 135-8550 | |
| 103 | Chungbuk National University Hospital ( Site 0201) | Cheongju si | Chungbuk | Korea, Republic of | 28644 |
| 104 | Seoul National University Bundang Hospital ( Site 0204) | Seongnam-si | Kyonggi-do | Korea, Republic of | 13620 |
| 105 | Asan Medical Center ( Site 0203) | Songpagu | Seoul | Korea, Republic of | 05505 |
| 106 | Severance Hospital Yonsei University Health System ( Site 0202) | Seoul | Korea, Republic of | 03722 | |
| 107 | Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801) | Lisboa | Portugal | 1769-001 | |
| 108 | Hospital CUF Porto ( Site 1802) | Porto | Portugal | 4100-180 | |
| 109 | Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800) | Porto | Portugal | 4200-072 | |
| 110 | Hematology and Oncology Institute ( Site 2105) | Manati | Puerto Rico | 00674 | |
| 111 | Ad-Vance Medical Research LLC ( Site 2103) | Ponce | Puerto Rico | 00717 | |
| 112 | Puerto Rico Medical Research Center LLC ( Site 2101) | San Juan | Puerto Rico | 00918 | |
| 113 | GBUZ Republican Clinical Oncological Dispensary ( Site 0922) | Ufa | Baskortostan, Respublika | Russian Federation | 450054 |
| 114 | Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918) | Krasnoyarsk | Krasnoyarskiy Kray | Russian Federation | 660133 |
| 115 | Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905) | Moscow | Moskva | Russian Federation | 105094 |
| 116 | Central Clinical Hospital of the Administration of the President ( Site 0910) | Moscow | Moskva | Russian Federation | 121359 |
| 117 | Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site | Omsk | Omskaya Oblast | Russian Federation | 644013 |
| 118 | SPb SBHI City Clinical Oncological Dispensary ( Site 0901) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 198255 |
| 119 | Railway Hospital of OJSC ( Site 0907) | Saint-Petersburg | Sankt-Peterburg | Russian Federation | 195271 |
| 120 | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903) | Saint-Petersburg | Sankt-Peterburg | Russian Federation | 197758 |
| 121 | GBUZ SPb CRPCstmc(o) ( Site 0921) | Sankt- Peterburg | Sankt-Peterburg | Russian Federation | 197758 |
| 122 | Pavlov First Saint Petersburg State Medical University ( Site 0917) | St. Petersburg | Sankt-Peterburg | Russian Federation | 197022 |
| 123 | Hospital Central de Asturias ( Site 1002) | Oviedo | Asturias | Spain | 33011 |
| 124 | Consorci Hospitalari Mataro ( Site 1008) | Mataro | Barcelona | Spain | 08304 |
| 125 | Hospital Universitario Marques de Valdecilla ( Site 1003) | Santander | Cantabria | Spain | 39008 |
| 126 | Hospital Universitario Insular de Gran Canaria ( Site 1011) | Las Palmas de Gran Canaria | Las Palmas | Spain | 35001 |
| 127 | Hospital Universitario Puerta de Hierro ( Site 1007) | Majadahonda | Madrid | Spain | 28222 |
| 128 | Hospital Universitario Quiron Madrid ( Site 1012) | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 129 | Hospital Clinico de Valencia ( Site 1010) | Valencia | Valenciana, Comunitat | Spain | 46010 |
| 130 | Hospital Universitari Vall d Hebron ( Site 1004) | Barcelona | Spain | 08035 | |
| 131 | Hospital Ciudad de Jaen ( Site 1000) | Jaen | Spain | 23007 | |
| 132 | Hospital Universitario Fundacion Jimenez Diaz ( Site 1005) | Madrid | Spain | 28040 | |
| 133 | Hospital Universitario 12 de Octubre ( Site 1006) | Madrid | Spain | 28041 | |
| 134 | Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108) | Cottingham | East Riding Of Yorkshire | United Kingdom | HU16 5JQ |
| 135 | Nottingham City Hospital Campus ( Site 1105) | Nottingham | England | United Kingdom | NG5 1PB |
| 136 | Leicester Royal Infirmary ( Site 1110) | Leicester | Leicestershire | United Kingdom | LE1 5WW |
| 137 | North Middlesex University Hospital NHS Trust ( Site 1109) | London | London, City Of | United Kingdom | N18 1QX |
| 138 | Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102) | London | London, City Of | United Kingdom | SE1 9RT |
| 139 | Mount Vernon Cancer Centre ( Site 1107) | Northwood | London, City Of | United Kingdom | HA6 2RN |
| 140 | Aberdeen Royal Infirmary ( Site 1114) | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
| 141 | University Hospital Coventry and Warwickshire NHS Trust ( Site 1112) | Coventry | Warwickshire | United Kingdom | CV2 2DX |
| 142 | Birmingham Heartlands Hospital ( Site 1103) | Birmingham | United Kingdom | B9 5SS | |
| 143 | St James s University Hospital ( Site 1106) | Leeds | United Kingdom | LS9 7TF |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
- Eisai Inc.
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 7902-008
- MK-7902-008
- LEAP-008
- E7080-G000-316
- 195003
- 2018-003791-12