Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-7902-007 | Other Identifier | MSD | |
| E7080-G000-314 | Other Identifier | Eisai Protocol Number | |
| LEAP-007 | Other Identifier | MSD | |
| 194670 | Registry Identifier | JAPIC-CTI | |
| 2018-003794-98 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain on treatment will receive open-label pembrolizumab only.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + Lenvatinib | Experimental | Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. |
|
| Pembrolizumab + Placebo | Active Comparator | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was 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. The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 was presented. | Up to approximately 25 months |
| Overall Survival (OS) | OS was defined as the time from date of randomization to date of death from any cause. OS was presented. | Up to approximately 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Clinical Research Center ( Site 0511) | Anchorage | Alaska | 99503 | United States | ||
| Ironwood Cancer & Research Centers ( Site 0541) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38159809 | Result | Yang JC, Han B, De La Mora Jimenez E, Lee JS, Koralewski P, Karadurmus N, Sugawara S, Livi L, Basappa NS, Quantin X, Dudnik J, Ortiz DM, Mekhail T, Okpara CE, Dutcus C, Zimmer Z, Samkari A, Bhagwati N, Csoszi T. Pembrolizumab With or Without Lenvatinib for First-Line Metastatic NSCLC With Programmed Cell Death-Ligand 1 Tumor Proportion Score of at least 1% (LEAP-007): A Randomized, Double-Blind, Phase 3 Trial. J Thorac Oncol. 2024 Jun;19(6):941-953. doi: 10.1016/j.jtho.2023.12.023. Epub 2023 Dec 29. | |
| 33300372 |
| Label | URL |
|---|---|
| Merck Clinical Trial Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 623 total participants randomized in the MK-7902-007 global study, 80 were also randomized in the China extension study for MK-7902-007 (NCT04676412).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab + Lenvatinib | Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lenvatinib | Drug | oral capsule |
|
|
| Placebo for lenvatinib | Drug | oral capsule |
|
| Up to approximately 25 months |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported | Through 90 days post last dose of study treatment (Up to approximately 27 months) |
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported. | Through last dose of study treatment (Up to approximately 24 months) |
| Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented. | Baseline and Week 21 |
| Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in cough (EORTC QLQ-LC13 Item 31) score was presented. | Baseline and Week 21 |
| Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-LC13 chest pain (Item 40) score was presented. | Baseline and Week 21 |
| Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score was presented. | Baseline and Week 21 |
| Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented. | Baseline and Week 21 |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status /Quality of Life (Items 29 & 30) Scale Combined Score | EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicates a better outcome. | Up to approximately 25 months |
| Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 31). A longer TTD indicates a better outcome. | Up to approximately 25 months |
| Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 40). A longer TTD indicates a better outcome. | Up to approximately 25 months |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). A longer TTD indicates a better outcome. | Up to approximately 25 months |
| Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicates a better outcome. | Up to approximately 25 months |
| Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8) | 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; score range:1=Not at All to 4=Very Much). 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; score range:1=Not at All to 4=Very Much ) and chest pain (Item 40, score range: 1=Not at All to 4=Very Much). The combined score of items 31, 40 and 8 was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD in the composite endpoint of EORTC QLQ-LC13 Item 31, EORTC QLQ-LC13 Item 40, EORTC QLQ-C30 Item 8 scale score was presented, defined as the time to first onset of a ≥10point decrease from baseline in anyone of the three scale items. A longer TTD indicates better outcome. | Up to approximately 25 months |
| Chandler |
| Arizona |
| 85224 |
| United States |
| CBCC Global Research, Inc. ( Site 0532) | Bakersfield | California | 93309 | United States |
| Scripps Cancer Center ( Site 0521) | La Jolla | California | 92037 | United States |
| Florida Hospital ( Site 0526) | Orlando | Florida | 32803 | United States |
| Northwest Georgia Oncology Centers PC ( Site 0518) | Marietta | Georgia | 30060 | United States |
| Illinois Cancer Care, PC ( Site 0557) | Peoria | Illinois | 61615 | United States |
| Parkview Cancer Center ( Site 0542) | Fort Wayne | Indiana | 46845 | United States |
| University of Kentucky School of Medicine & Hospitals ( Site 0517) | Lexington | Kentucky | 40536 | United States |
| Anne Arundel Medical Center Oncology and Hematology ( Site 0514) | Annapolis | Maryland | 21401 | United States |
| Munson Medical Center ( Site 0512) | Traverse City | Michigan | 49684 | United States |
| Park Nicollet Frauenshuh Cancer Center ( Site 0554) | Saint Louis Park | Minnesota | 55426 | United States |
| University of Missouri Health Care ( Site 0555) | Columbia | Missouri | 65212 | United States |
| Billings Clinic Cancer Center ( Site 0508) | Billings | Montana | 59101 | United States |
| Cone Health Cancer Center at Alamance Regional ( Site 0527) | Greensboro | North Carolina | 27403 | United States |
| Genesis Cancer Care Center ( Site 0559) | Zanesville | Ohio | 43701 | United States |
| Oregon Health Sciences University ( Site 0544) | Portland | Oregon | 97239 | United States |
| Central Texas Veterans Healthcare System ( Site 0533) | Temple | Texas | 76504 | United States |
| Orange Health Services ( Site 0002) | Orange | New South Wales | 2800 | Australia |
| Wollongong Private Hospital ( Site 0005) | Wollongong | New South Wales | 2500 | Australia |
| The Prince Charles Hospital ( Site 0011) | Chermside | Queensland | 4032 | Australia |
| Ballarat Oncology and Haematology Services ( Site 0008) | Wendouree | Victoria | 3355 | Australia |
| St John of God Murdoch Medical Clinic ( Site 0001) | Perth | Western Australia | 6150 | Australia |
| Cross Cancer Institute ( Site 0400) | Edmonton | Alberta | T6G 1Z2 | Canada |
| Lions Gate Hospital ( Site 0407) | North Vancouver | British Columbia | V7L 2L7 | Canada |
| William Osler Health System (Brampton Civic Hospital) ( Site 0402) | Brampton | Ontario | L6R 3J7 | Canada |
| Windsor Regional Cancer Program ( Site 0404) | Windsor | Ontario | N8W 2X3 | Canada |
| McGill University Health Centre ( Site 0418) | Montreal | Quebec | H4A 3J1 | Canada |
| Beijing Chest Hospital Capital Medical University ( Site 0111) | Beijing | Anhui | 101149 | China |
| Anhui Provincial Hospital ( Site 0108) | Hefei | Anhui | 230001 | China |
| The First Affiliated Hospital of Anhui Medical University ( Site 0113) | Hefei | Anhui | 230088 | China |
| Peking Union Medical College Hospital ( Site 0105) | Beijing | Beijing Municipality | 100006 | China |
| Beijing Cancer Hospital ( Site 0102) | Beijing | Beijing Municipality | 100036 | China |
| Xiangya Hospital of Central South University ( Site 0115) | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital ( Site 0104) | Changsha | Hunan | 410013 | China |
| Jiangsu Cancer Hospital ( Site 0101) | Nanjing | Jiangsu | 210009 | China |
| The First Hospital of Jilin University ( Site 0110) | Changchun | Jilin | 130021 | China |
| Zhongshan Hospital Fudan University ( Site 0100) | Shanghai | Shanghai Municipality | 200433 | China |
| Shanghai Chest Hospital ( Site 0112) | Shanghai | Shanghai Municipality | 230000 | China |
| 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103) | XiAn | Shanxi | 710061 | China |
| West China Hospital of Sichuan University ( Site 0117) | Chengdu | Sichuan | 510115 | China |
| The First Affiliated Hospital Zhejiang University ( Site 0106) | Hangzhou | Zhejiang | 310003 | China |
| Hangzhou First People's Hospital ( Site 0109) | Hangzhou | Zhejiang | 310006 | China |
| 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114) | Hangzhou | Zhejiang | 310009 | China |
| Zhejiang Cancer Hospital ( Site 0116) | Hangzhou | Zhejiang | 310022 | China |
| Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368) | Medellín | Antioquia | 050015 | Colombia |
| Fundacion Centro de Investigacion Clinica CIC ( Site 0366) | Medellín | Antioquia | 050021 | Colombia |
| Biomelab S A S ( Site 0365) | Barranquilla | Atlántico | 080002 | Colombia |
| Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374) | Valledupar | Cesar Department | 200001 | Colombia |
| Oncomedica S.A. ( Site 0372) | Montería | Departamento de Córdoba | 230002 | Colombia |
| Centro Medico Imbanaco de Cali S.A ( Site 0369) | Cali | Valle del Cauca Department | 760023 | Colombia |
| AS Ida-Tallinna Keskhaigla ( Site 0161) | Tallinn | Harju | 11312 | Estonia |
| SA Pohja-Eesti Regionaalhaigla ( Site 0162) | Tallinn | Harju | 13419 | Estonia |
| SA Tartu Ulikooli Kliinikum ( Site 0160) | Tartu | Tartu | 50406 | Estonia |
| CHU Jean Minjoz ( Site 0167) | Besançon | Doubs | 25000 | France |
| Institut Curie - Centre Rene Huguenin ( Site 0181) | Saint-Cloud | Hauts-de-Seine | 92210 | France |
| ICM Val D Auerelle ( Site 0177) | Montpellier | Herault | 34090 | France |
| CHU de Grenoble - Hopital Michallon ( Site 0169) | La Tronche | Isere | 38700 | France |
| Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185) | Saint-Herblain | Loire-Atlantique | 44805 | France |
| Centre Hospitalier de la Cote Basque ( Site 0173) | Bayonne | Pyrenees-Atlantiques | 64109 | France |
| CHU de Rouen ( Site 0174) | Rouen | Seine-Maritime | 76000 | France |
| CHU Amiens Sud ( Site 0182) | Amiens | Somme | 80054 | France |
| Centre hospitalier Toulon Sainte-Musse ( Site 0172) | Toulon | Var | 83056 | France |
| Institut Curie ( Site 0166) | Paris | 75248 | France |
| Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207) | Gyula | Bekes County | 5700 | Hungary |
| Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202) | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| CRU Hungary KFT ( Site 0209) | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| Petz Aladar Megyei Oktato Korhaz ( Site 0213) | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203) | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
| Tudogyogyintezet Torokbalint ( Site 0205) | Törökbálint | Pest County | 2045 | Hungary |
| Semmelweis Egyetem ( Site 0210) | Budapest | 1083 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217) | Kaposvár | 7400 | Hungary |
| Bnei Zion Medical Center ( Site 0227) | Haifa | Heifa | 3339419 | Israel |
| Sheba Medical Center ( Site 0220) | Ramat Gan | Tel Aviv | 5266202 | Israel |
| Soroka Medical Center ( Site 0222) | Beersheba | 8457108 | Israel |
| Rambam Medical Center ( Site 0223) | Haifa | 3109601 | Israel |
| Meir Medical Center ( Site 0221) | Kfar Saba | 4428132 | Israel |
| Rabin Medical Center ( Site 0224) | Petah Tikva | 4941492 | Israel |
| Sourasky Medical Center ( Site 0225) | Tel Aviv | 6423906 | Israel |
| Barzilai Medical Center ( Site 0226) | Ashkelon | Ḥeifā | 7830604 | Israel |
| Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233) | Rome | Lazio | 00185 | Italy |
| Presidio Ospedaliero San Vincenzo ( Site 0231) | Taormina | Messina | 98039 | Italy |
| Centro di Riferimento Oncologico CRO ( Site 0235) | Aviano | Pordenone | 33081 | Italy |
| Azienda Ospedaliera San Giuseppe Moscati ( Site 0234) | Avellino | 83100 | Italy |
| Universita Magna Grecia ( Site 0230) | Catanzaro | 88100 | Italy |
| A.O. Universitaria Careggi ( Site 0236) | Florence | 50134 | Italy |
| Ospedale Santa Maria delle Croci ( Site 0232) | Ravenna | 48121 | Italy |
| Policlinico Gemelli di Roma ( Site 0237) | Roma | 00168 | Italy |
| Aichi Cancer Center Hospital ( Site 0018) | Nagoya | Aichi-ken | 464-8681 | Japan |
| Kurume University Hospital ( Site 0025) | Kurume | Fukuoka | 830-0011 | Japan |
| Hyogo Cancer Center ( Site 0021) | Akashi | Hyōgo | 673-8558 | Japan |
| Kanagawa Cardiovascular and Respiratory Center ( Site 0026) | Yokohama | Kanagawa | 236-0051 | Japan |
| Kanagawa Cancer Center ( Site 0023) | Yokohama | Kanagawa | 241-8515 | Japan |
| Miyagi Cancer Center ( Site 0028) | Natori-shi | Miyagi | 981-1293 | Japan |
| Sendai Kousei Hospital ( Site 0022) | Sendai | Miyagi | 980-0873 | Japan |
| National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027) | Sakai | Osaka | 591-8555 | Japan |
| Kindai University Hospital ( Site 0017) | Sayama | Osaka | 589-8511 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 0015) | Fukuoka | 810-8563 | Japan |
| Kyushu University Hospital ( Site 0030) | Fukuoka | 812-8582 | Japan |
| Okayama University Hospital ( Site 0020) | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute ( Site 0019) | Osaka | 541-8567 | Japan |
| Toranomon Hospital ( Site 0016) | Tokyo | 105-8470 | Japan |
| Juntendo University Hospital ( Site 0029) | Tokyo | 113-8431 | Japan |
| Nippon Medical School Hospital ( Site 0024) | Tokyo | 113-8603 | Japan |
| Hospital Tengku Ampuan Afzan ( Site 0062) | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Pulau Pinang. ( Site 0065) | George Town | Pulau Pinang | 10990 | Malaysia |
| Institut Kanser Negara - National Cancer Institute ( Site 0063) | Putrajaya | Putrajaya | 62250 | Malaysia |
| Sarawak General Hospital ( Site 0064) | Kuching | Sarawak | 93586 | Malaysia |
| Beacon Hospital Sdn Bhd ( Site 0067) | Petaling Jaya | Selangor | 46050 | Malaysia |
| University Malaya Medical Centre ( Site 0061) | Kuala Lumpur | 59100 | Malaysia |
| Gleneagles Penang ( Site 0066) | Pulau Pinang | 10050 | Malaysia |
| Consultorios de Medicina Especializada del Sector Privado ( Site 0388) | Guadalajara | Jalisco | 44680 | Mexico |
| Medica Sur S.A.B de C.V. ( Site 0384) | Mexico City | Mexico City | 14050 | Mexico |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381) | Madero | Tamaulipas | 89440 | Mexico |
| Instituto Nacional de Cancerologia. ( Site 0382) | Mexico City | 14080 | Mexico |
| Oaxaca Site Management Organization SC ( Site 0389) | Oaxaca City | 68000 | Mexico |
| Ars Medical Sp. z o.o. ( Site 0254) | Piła | Greater Poland Voivodeship | 64-920 | Poland |
| Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253) | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243) | Krakow | Lesser Poland Voivodeship | 31-826 | Poland |
| Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247) | Zielona Góra | Lubusz Voivodeship | 65-046 | Poland |
| Centrum Medyczne Pratia Ostroleka ( Site 0242) | Ostrołęka | Masovian Voivodeship | 07-410 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252) | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250) | Przemyśl | Podkarpackie Voivodeship | 37-700 | Poland |
| SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256) | Lodz | Łódź Voivodeship | 99-153 | Poland |
| Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262) | Ufa | Baskortostan, Respublika | 450054 | Russia |
| Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266) | Krasnoyarsk | Krasnoyarsk Krai | 660133 | Russia |
| SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265) | Samara | Samara Oblast | 443031 | Russia |
| SBHI Leningrad Regional Clinical Hospital ( Site 0263) | Saint Petersburg | Sankt-Peterburg | 194291 | Russia |
| Railway Hospital of OJSC ( Site 0268) | Saint Petersburg | Sankt-Peterburg | 195271 | Russia |
| City Clinical Oncology Center ( Site 0260) | Saint Petersburg | Sankt-Peterburg | 198255 | Russia |
| Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269) | Kazan' | Tatarstan, Respublika | 420029 | Russia |
| Seoul National University Bundang Hospital ( Site 0075) | Seongnam-si | Kyonggi-do | 13620 | South Korea |
| Chungbuk National University Hospital ( Site 0079) | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Ulsan University Hospital ( Site 0077) | Ulsan | Ulsan-Kwangyokshi | 44033 | South Korea |
| Asan Medical Center ( Site 0076) | Seoul | 05505 | South Korea |
| SMG-SNU Boramae Medical Center ( Site 0078) | Seoul | 07061 | South Korea |
| National Taiwan University Hospital Hsin-Chu Branch ( Site 0087) | Hsinchu | 300 | Taiwan |
| Taipei Medical University Shuang Ho Hospital ( Site 0090) | New Taipei City | 235 | Taiwan |
| National Cheng Kung University Hospital ( Site 0086) | Tainan | 70457 | Taiwan |
| National Taiwan University Hospital ( Site 0088) | Taipei | 10002 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091) | Taipei | 112 | Taiwan |
| Taipei Veterans General Hospital ( Site 0089) | Taipei | 112 | Taiwan |
| Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321) | Konya | Adana | 42080 | Turkey (Türkiye) |
| Gulhane Egitim ve Arastirma Hastanesi ( Site 0316) | Ankara | 06010 | Turkey (Türkiye) |
| Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318) | Ankara | 06200 | Turkey (Türkiye) |
| Baskent Universitesi Ankara Hastanesi ( Site 0319) | Ankara | 06490 | Turkey (Türkiye) |
| Antalya Memorial Hospital Department of Medical Oncology ( Site 0324) | Antalya | 07020 | Turkey (Türkiye) |
| Akdeniz Universitesi Tip Fakultesi ( Site 0322) | Antalya | 07070 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314) | Izmir | 35340 | Turkey (Türkiye) |
| Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323) | Sakarya | 54290 | Turkey (Türkiye) |
| Samsun Medical Park Hastanesi ( Site 0320) | Samsun | 55200 | Turkey (Türkiye) |
| Cherkasy Regional Hospital ( Site 0336) | Cherkasy | Cherkasy Oblast | 18009 | Ukraine |
| City Clinical Hosp.4 of DCC ( Site 0338) | Dnipro | Dnipropetrovsk Oblast | 49102 | Ukraine |
| MI Precarpathian Clinical Oncology Center ( Site 0346) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Regional Centre of Oncology-Thoracic organs ( Site 0337) | Kharkiv | Kharkiv Oblast | 61070 | Ukraine |
| Ukranian Center of TomoTherapy ( Site 0344) | Kropyvnytskiy | Kirovohrad Oblast | 25011 | Ukraine |
| Medical Center Verum ( Site 0334) | Kyiv | Kyivska Oblast | 03039 | Ukraine |
| Kyiv City Clinical Oncology Centre ( Site 0339) | Kyiv | Kyivska Oblast | 03115 | Ukraine |
| Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331) | Kyiv | Kyivska Oblast | 03126 | Ukraine |
| Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341) | Lviv | Lviv Oblast | 79031 | Ukraine |
| MI Odessa Regional Oncological Centre ( Site 0333) | Odesa | Odesa Oblast | 65055 | Ukraine |
| Podillya Regional Center of Oncology ( Site 0343) | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
| Derived |
| Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10. |
| Plain Language Summary | View source |
| FG001 | Pembrolizumab + Placebo | Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab + Lenvatinib | Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
| BG001 | Pembrolizumab + Placebo | Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Randomization of participants in the study was stratified by an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature). | Count of Participants | Participants |
| |||||||||||||||
| Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline | Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Randomization of participants in the study was stratified by PD-L1 tumor proportion score (TPS) at baseline (1-49% or ≥ 50%). Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor. | Count of Participants | Participants |
| |||||||||||||||
| Geographic Region | Randomization of participants in this study was stratified by geographic region of the enrolling site (East Asia or non-East Asia). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was 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. The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 was presented. | The analysis population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS was defined as the time from date of randomization to date of death from any cause. OS was presented. | The analysis population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR was defined as the percentage of participants in the analysis population 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) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented. | The analysis population consisted of all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported | All randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Through 90 days post last dose of study treatment (Up to approximately 27 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported. | All randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Through last dose of study treatment (Up to approximately 24 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented. | All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 21 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in cough (EORTC QLQ-LC13 Item 31) score was presented. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 31 assessment data available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 21 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-LC13 chest pain (Item 40) score was presented. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 40 assessment data available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 21 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score was presented. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 8 assessment data available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 21 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 1-5 assessment data available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Week 21 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status /Quality of Life (Items 29 & 30) Scale Combined Score | EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participant responses to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicates a better outcome. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 29 and Item 30 assessment data available. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 31). A longer TTD indicates a better outcome. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-LC13 Item assessment data available. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score | EORTC QLQ-LC13 is a lung cancer specific questionnaire. Participant responses to the question: "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in cough (Item 40). A longer TTD indicates a better outcome. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-LC13 Item 40 assessment data available. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in dyspnea (Item 8). A longer TTD indicates a better outcome. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ Item 8 assessment data available. | Posted | Mean | 95% Confidence Interval | Months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicates a better outcome. | All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Items 1-5 assessment data available. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8) | 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; score range:1=Not at All to 4=Very Much). 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; score range:1=Not at All to 4=Very Much ) and chest pain (Item 40, score range: 1=Not at All to 4=Very Much). The combined score of items 31, 40 and 8 was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD in the composite endpoint of EORTC QLQ-LC13 Item 31, EORTC QLQ-LC13 Item 40, EORTC QLQ-C30 Item 8 scale score was presented, defined as the time to first onset of a ≥10point decrease from baseline in anyone of the three scale items. A longer TTD indicates better outcome. | All randomized participants who received at least one dose of study treatment and have at least one had at least one EORTC-QLQ-C30 or EORTC QLQ-LC13 assessment data available. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 25 months |
|
Up to approximately 61 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenvatinib + Pembrolizumab | Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued lenvatinib and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. | 229 | 309 | 192 | 309 | 296 | 309 |
| EG001 | Placebo + Pembrolizumab | Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. | 232 | 314 | 118 | 312 | 275 | 312 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Polyserositis | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Skin angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin lesion inflammation | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vancomycin infusion reaction | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Mar 26, 2025 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
| TPS = ≥ 50% |
|
| Non-East Asia |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
| OG001 | Pembrolizumab + Placebo | Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
|
|
|
|
|
|
|
|
|
|
|
|
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule.
|
|
|
| OG001 |
| Pembrolizumab + Placebo |
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
|
|
|
|
|
|
|
|
|
|
|
|
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
|
|
|
| OG001 | Pembrolizumab + Placebo | Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity. As of 30-Jul-2021, participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only at same dose and schedule. |
|
|
|