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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7902-008 | Other Identifier | MSD | |
| LEAP-008 | Other Identifier | MSD | |
| E7080-G000-316 | Other Identifier | Eisai Inc. | |
| 195003 | Registry Identifier | JAPIC-CTI | |
| 2022-501439-18-00 | Registry Identifier | EU CT | |
| U1111-1280-4337 | Registry Identifier | UTN | |
| 2018-003791-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab+Lenvatinib | Experimental | 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. |
|
| Docetaxel | Active Comparator | 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. |
|
| Lenvatinib Monotherapy | Experimental | Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion of pembrolizumab at 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to the date of death due to any cause. | Up to ~47 months |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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 was 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. | Up to ~47 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel | 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 was 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. |
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Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous Non-Small Cell Lung Cancer (NSCLC) -Stage IV: M1a, M1b, M1c.
Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
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 Response Evaluation Criteria in Solid Tumors (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 ≥90 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 ≥30 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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604) | Bakersfield | California | 93309 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40473109 | Result | Leighl NB, Paz-Ares L, Abreu DR, Hui R, Baka S, Bigot F, Nishio M, Smolin A, Ahmed S, Schoenfeld AJ, Daher S, Cortinovis DL, Di Noia V, Linardou H, Gainor JF, Dutcus C, Okpara CE, Deng X, Kush D, Arunachalam A, Song A, Cho BC. LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-Programmed Cell Death Protein 1 or Anti-Programmed Cell Death Ligand 1 Plus Platinum Chemotherapy. J Thorac Oncol. 2025 Oct;20(10):1489-1504. doi: 10.1016/j.jtho.2025.05.020. Epub 2025 Jun 3. | |
| 34409776 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab+Lenvatinib | Participants received 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 is administered for up to 35 treatment cycles (~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Dec 8, 2023 |
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| Lenvatinib | Drug | Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose. |
|
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| Docetaxel | Drug | IV infusion of docetaxel at 75 mg/m^2. |
|
|
| Up to ~47 months |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy | 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 was 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. | Up to ~47 months |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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 was 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. | Up to ~47 months |
| Number of Participants Experiencing an Adverse Event (AE) | 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 experienced an AE is presented. | Up to ~47 months |
| Number of Participants Discontinuing Study Treatment Due to an AE | The number of participants who discontinued study treatment due to an AE is presented. | Up to ~47 months |
| 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 | 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 scores is presented. | Baseline and Week 12 |
| Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score | 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 is presented. | Baseline and Week 12 |
| Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score | 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 is presented. | Baseline and Week 12 |
| Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score | 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 is presented. | Baseline and Week 12 |
| Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score | 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 is presented. | Baseline and Week 12 |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. A longer TTD indicates a better outcome | Up to 24 months |
| Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. | Up to ~24 months |
| Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. | Up to ~24 months |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score | 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. | Up to ~24 months |
| Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. | Up to ~24 months |
| Time to True Deterioration (TTD) in EORTC Composite Symptom Score for Cough (QLQ-LC13 Item 31), Chest Pain (QLQ-LC13 Item 40), or Dyspnea (QLQ-C30 Item 8) | EORTC QLQ-C30 includes a single-item scale score for dyspnea (Item 8), the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, which includes a single-item scale score for cough (Item 31) and chest pain (Item 40). Time to True Deterioration for the Composite Endpoint of EORTC QLQ- LC13 Cough, EORTC QLQ- LC13 Chest Pain, or EORTC QLQ-C30 Dyspnea is presented, defined as the time to first onset of a ≥10-point decrease from baseline in any one of 3 scale items with confirmation by the subsequent visit of a 10 or more-point deterioration from baseline in the same scale as the first onset under right-censoring rule. | Up to ~ 24 months |
| Cancer Specialists of North Florida - Fleming Island ( Site 1675) |
| Fleming Island |
| Florida |
| 32003 |
| United States |
| Mid-Florida Cancer Centers ( Site 1611) | Orange City | Florida | 32763 | United States |
| University of Kentucky School of Medicine & Hospitals ( Site 1621) | Lexington | Kentucky | 40536 | United States |
| Hematology Oncology Clinic ( Site 1680) | Baton Rouge | Louisiana | 70809 | United States |
| Harry & Jeanette Weinberg Cancer Institute ( Site 1626) | Baltimore | Maryland | 21237 | United States |
| Medstar Good Samaritan Hospital ( Site 1625) | Baltimore | Maryland | 21239 | United States |
| Massachusetts General Hospital ( Site 1622) | Boston | Massachusetts | 02114 | United States |
| MGH - North Shore Cancer Center ( Site 1668) | Danvers | Massachusetts | 01923 | United States |
| The Mass General Cancer Center at Newton-Wellesley ( Site 1692) | Newton | Massachusetts | 02462 | United States |
| University of Massachusetts Medical School ( Site 1693) | Worcester | Massachusetts | 01655 | United States |
| Billings Clinic ( Site 1631) | Billings | Montana | 59101 | United States |
| Bozeman Health Deaconness Cancer Center ( Site 1632) | Bozeman | Montana | 59715 | United States |
| Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664) | Basking Ridge | New Jersey | 07920 | United States |
| Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662) | Commack | New York | 11725 | United States |
| Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666) | Harrison | New York | 10604 | United States |
| Memorial Sloan-Kettering Cancer Center ( Site 1661) | New York | New York | 10065 | United States |
| New York Cancer and Blood Specialists ( Site 1696) | Port Jefferson Station | New York | 11776 | United States |
| University of Rochester ( Site 1638) | Rochester | New York | 14642 | United States |
| Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670) | Uniondale | New York | 11553 | United States |
| TriHealth Cancer Institute ( Site 1672) | Cincinnati | Ohio | 45220 | United States |
| MetroHealth Medical Center ( Site 1694) | Cleveland | Ohio | 44109 | United States |
| Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644) | Portland | Oregon | 97227 | United States |
| Fox Chase Cancer Center ( Site 1647) | Philadelphia | Pennsylvania | 19111 | United States |
| Thompson Cancer Survival Center ( Site 1695) | Knoxville | Tennessee | 37916 | United States |
| Millenium Physicians ( Site 1690) | Houston | Texas | 77090 | United States |
| Instituto de Investigaciones Metabolicas ( Site 2004) | Caba | Buenos Aires | C1012AAR | Argentina |
| Hospital Britanico de Buenos Aires ( Site 2002) | Buenos Aires | Buenos Aires F.D. | C1280AEB | Argentina |
| Sanatorio Parque ( Site 2005) | Rosario | Santa Fe Province | S2000DSV | Argentina |
| Hospital Aleman ( Site 2000) | Buenos Aires | C1118AAT | Argentina |
| CEMIC ( Site 2003) | Buenos Aires | C1431FWO | Argentina |
| Blacktown Hospital ( Site 0004) | Blacktown | New South Wales | 2148 | Australia |
| Port Macquarie Base Hospital ( Site 0003) | Port Macquarie | New South Wales | 2444 | Australia |
| Westmead Hospital ( Site 0005) | Westmead | New South Wales | 2145 | Australia |
| Southern Medical Day Care Centre ( Site 0001) | Wollongong | New South Wales | 2500 | Australia |
| Princess Alexandra Hospital - Division of Cancer Services ( Site 0002) | Woolloongabba | Queensland | 4102 | Australia |
| Calvary Central Districts Hospital ( Site 0007) | Elizabeth Vale | South Australia | 5112 | Australia |
| Bendigo Cancer Centre ( Site 0008) | Bendigo | Victoria | 3552 | Australia |
| CancerCare Manitoba ( Site 1504) | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Kingston Health Sciences Centre ( Site 1503) | Kingston | Ontario | K7L 2V7 | Canada |
| London Regional Cancer Program - London HSC ( Site 1505) | London | Ontario | N6A 5W9 | Canada |
| Princess Margaret Cancer Centre ( Site 1502) | Toronto | Ontario | M5G 2M9 | Canada |
| CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501) | Montreal | Quebec | H3T 1M5 | Canada |
| CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514) | Québec | Quebec | G1R 2J6 | Canada |
| Rodrigo Botero SAS ( Site 1300) | MedellÃn | Antioquia | 050030 | Colombia |
| Clinica de la Costa Ltda. ( Site 1309) | Barranquilla | Atlántico | 080020 | Colombia |
| Administradora Country SA - Clinica del Country ( Site 1307) | Bogotá | Bogota D.C. | 110221 | Colombia |
| Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304) | Bogotá | Bogota D.C. | 110311 | Colombia |
| Sociedad de OncologÃa Y HematologÃa del Cesar S.A.S. ( Site 1305) | Valledupar | Cesar Department | 200001 | Colombia |
| Oncomedica S.A. ( Site 1302) | MonterÃa | Departamento de Córdoba | 230001 | Colombia |
| Centro Medico Imbanaco de Cali S.A ( Site 1301) | Cali | Valle del Cauca Department | 760042 | Colombia |
| CHU Caen Service de Pneumologie ( Site 0401) | Caen | Calvados | 14033 | France |
| HIA Percy-Clamart ( Site 0411) | Clamart | Hauts-de-Seine | 92140 | France |
| ICO Centre Paul Papin ( Site 0412) | Angers | Maine-et-Loire | 49100 | France |
| Clinique Ambroise Pare ( Site 0402) | Beuvry | Pas-de-Calais | 62660 | France |
| Centre Hospitalier General - Avignon ( Site 0407) | Avignon | Provence-Alpes-Côte d'Azur Region | 84000 | France |
| Centre Hospitalier Le Mans ( Site 0406) | Le Mans | Sarthe | 72037 | France |
| Institut Curie ( Site 0400) | Paris | 75005 | France |
| Hopital Europeen Georges Pompidou ( Site 0408) | Paris | 75015 | France |
| Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501) | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Evangelisches Krankenhaus Hamm gGmbH ( Site 0504) | Hamm | North Rhine-Westphalia | 59063 | Germany |
| SRH Wald-Klinikum Gera GmbH ( Site 0503) | Gera | Thuringia | 07548 | Germany |
| Vivantes Klinikum Spandau ( Site 0505) | Berlin | 13585 | Germany |
| General Hospital of Chest Diseases "Sotiria" ( Site 1703) | Athens | Attica | 115 27 | Greece |
| Metropolitan Hospital-4th Oncology Dept ( Site 1700) | Athens | Attica | 185 47 | Greece |
| University Hospital of Ioannina ( Site 1701) | Ioannina | 455 00 | Greece |
| European Interbalkan Medical Center ( Site 1704) | Thessaloniki | 570 01 | Greece |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601) | Miskolc | Borsod-Abauj Zemplen county | 3526 | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606) | Székesfehérvár | Fejér | 8000 | Hungary |
| Petz Aladar Megyei Oktato Korhaz ( Site 0609) | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610) | Szolnok | Jász-Nagykun-Szolnok | 5004 | Hungary |
| Tudogyogyintezet Torokbalint ( Site 0602) | Törökbálint | Pest County | 2045 | Hungary |
| Veszprem Megyei Tudogyogyintezet ( Site 0607) | Farkasgyepű | Veszprém megye | 8582 | Hungary |
| Semmelweis Egyetem.. ( Site 0604) | Budapest | 1083 | Hungary |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 0603) | Budapest | 1121 | Hungary |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 0608) | Budapest | 1121 | Hungary |
| Soroka Medical Center ( Site 0701) | Beersheba | 8410101 | Israel |
| Rambam Medical Center ( Site 0703) | Haifa | 3525408 | Israel |
| Shaare Zedek Medical Center-Oncology ( Site 0706) | Jerusalem | 9013102 | Israel |
| Meir Medical Center ( Site 0702) | Kfar Saba | 4428132 | Israel |
| Rabin Medical Center ( Site 0700) | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center ( Site 0704) | Ramat Gan | 5262000 | Israel |
| Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705) | Tel Aviv | 6423906 | Israel |
| Ospedale San Gerardo - ASST Monza ( Site 0804) | Monza | Monza E Brianza | 20900 | Italy |
| Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807) | Rome | Roma | 00144 | Italy |
| A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810) | Palermo | Sicily | 90146 | Italy |
| Ospedale San Luigi Gonzaga ( Site 0802) | Orbassano | Torino | 10043 | Italy |
| Azienda Ospedaliera San Giuseppe Moscati ( Site 0809) | Avellino | 83100 | Italy |
| IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808) | Bari | 70124 | Italy |
| AOU Policlinico Vittorio Emanuele ( Site 0811) | Catania | 95123 | Italy |
| Istituto Nazionale dei Tumori ( Site 0806) | Milan | 20133 | Italy |
| Policlinico San Matteo - Fondazione IRCCS ( Site 0812) | Pavia | 27100 | Italy |
| Azienda Ospedaliera di Perugia ( Site 0805) | Perugia | 06132 | Italy |
| Kanagawa Cardiovascular and Respiratory Center ( Site 0105) | Yokohama | Kanagawa | 236-0051 | Japan |
| Sendai Kousei Hospital ( Site 0107) | Sendai | Miyagi | 980-0873 | Japan |
| Kansai Medical University Hospital ( Site 0104) | Hirakata | Osaka | 573-1191 | Japan |
| Chiba University Hospital ( Site 0106) | Chiba | 260-8677 | Japan |
| Niigata Cancer Center Hospital ( Site 0101) | Niigata | 951-8566 | Japan |
| National Cancer Center Hospital ( Site 0103) | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR ( Site 0100) | Tokyo | 135-8550 | Japan |
| Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801) | Lisbon | 1769-001 | Portugal |
| Hospital CUF Porto ( Site 1802) | Porto | 4100-180 | Portugal |
| Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800) | Porto | 4200-072 | Portugal |
| Hematology and Oncology Institute ( Site 2105) | Manati | 00674 | Puerto Rico |
| Ad-Vance Medical Research LLC ( Site 2103) | Ponce | 00717 | Puerto Rico |
| Puerto Rico Medical Research Center LLC ( Site 2101) | San Juan | 00918 | Puerto Rico |
| GBUZ Republican Clinical Oncological Dispensary ( Site 0922) | Ufa | Baskortostan, Respublika | 450054 | Russia |
| Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918) | Krasnoyarsk | Krasnoyarsk Krai | 660133 | Russia |
| Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905) | Moscow | Moscow | 105094 | Russia |
| Central Clinical Hospital of the Administration of the President ( Site 0910) | Moscow | Moscow | 121359 | Russia |
| Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site | Omsk | Omsk Oblast | 644013 | Russia |
| Railway Hospital of OJSC ( Site 0907) | Saint Petersburg | Sankt-Peterburg | 195271 | Russia |
| Pavlov First Saint Petersburg State Medical University ( Site 0917) | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| GBUZ SPb CRPCstmc(o) ( Site 0921) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| SPb SBHI City Clinical Oncological Dispensary ( Site 0901) | Saint Petersburg | Sankt-Peterburg | 198255 | Russia |
| Seoul National University Bundang Hospital ( Site 0204) | Seongnam-si | Kyonggi-do | 13620 | South Korea |
| Chungbuk National University Hospital ( Site 0201) | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Asan Medical Center ( Site 0203) | Songpagu | Seoul | 05505 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 0202) | Seoul | 03722 | South Korea |
| Consorci Hospitalari Mataro ( Site 1008) | Mataró | Barcelona | 08304 | Spain |
| Hospital Universitario Marques de Valdecilla ( Site 1003) | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Insular de Gran Canaria ( Site 1011) | Las Palmas de Gran Canaria | Las Palmas | 35001 | Spain |
| Hospital Universitario Puerta de Hierro ( Site 1007) | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Quiron Madrid ( Site 1012) | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Central de Asturias ( Site 1002) | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Clinico de Valencia ( Site 1010) | Valencia | Valenciana, Comunitat | 46010 | Spain |
| Hospital Universitari Vall d Hebron ( Site 1004) | Barcelona | 08035 | Spain |
| Hospital Ciudad de Jaen ( Site 1000) | Jaén | 23007 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz ( Site 1005) | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre ( Site 1006) | Madrid | 28041 | Spain |
| Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108) | Cottingham | East Riding Of Yorkshire | HU16 5JQ | United Kingdom |
| Nottingham City Hospital Campus ( Site 1105) | Nottingham | England | NG5 1PB | United Kingdom |
| Leicester Royal Infirmary ( Site 1110) | Leicester | Leicestershire | LE1 5WW | United Kingdom |
| North Middlesex University Hospital NHS Trust ( Site 1109) | London | London, City of | N18 1QX | United Kingdom |
| Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102) | London | London, City of | SE1 9RT | United Kingdom |
| Mount Vernon Cancer Centre ( Site 1107) | Northwood | London, City of | HA6 2RN | United Kingdom |
| Aberdeen Royal Infirmary ( Site 1114) | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| University Hospital Coventry and Warwickshire NHS Trust ( Site 1112) | Coventry | Warwickshire | CV2 2DX | United Kingdom |
| Birmingham Heartlands Hospital ( Site 1103) | Birmingham | B9 5SS | United Kingdom |
| St James s University Hospital ( Site 1106) | Leeds | LS9 7TF | United Kingdom |
| Derived |
| Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18. |
| 33300372 | 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 | Docetaxel | Participants received docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity. |
| FG002 | Lenvatinib | Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvantinib is administered until progressive disease or unacceptable toxicity. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab+Lenvatinib | Participants received 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 is administered for up to 35 treatment cycles (~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity. |
| BG001 | Docetaxel | Participants received docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity. |
| BG002 | Lenvatinib | Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvantinib is administered until progressive disease or unacceptable toxicity. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) at baseline | Participants were classified at baseline by 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 |
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| Sequence of Prior Anti-programmed cell death protein 1 (PD-1)/PD-L1 Therapy | Participants were classified at baseline by whether Anti-PD-1/PD-L1 was the type of therapy received immediately prior to enrollment, or not the immediate prior therapy received prior to enrollment | Count of Participants | Participants |
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| Programmed cell death ligand 1 (PD-L1)Status | Participants were stratified by PD-L1 status at baseline; Tumor proportion score (TPS) <50% or TPS>=50% | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | OS is defined as the time from randomization to the date of death due to any cause. | All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to ~47 months |
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| Primary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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 was 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. | All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to ~47 months |
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| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel | 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 was 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. | All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to ~47 months |
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| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy | 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 was 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. | All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the docetaxel arm were not analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to ~47 months |
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| Secondary | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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 was 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. | All randomized participants who had a confirmed or partial response, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed. | Posted | Median | Full Range | Months | Up to ~47 months |
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| Secondary | Number of Participants Experiencing an Adverse Event (AE) | 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 experienced an AE is presented. | All randomized participants who received at least 1 dose of study intervention | Posted | Number | Participants | Up to ~47 months |
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| Secondary | Number of Participants Discontinuing Study Treatment Due to an AE | The number of participants who discontinued study treatment due to an AE is presented. | All randomized participants who received at least 1 dose of study intervention | Posted | Number | Participants | Up to ~47 months |
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| Secondary | 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 | 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 scores is presented. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score | 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 is presented. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score | 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 is presented. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score | 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 is presented. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score | 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 is presented. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 12 |
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| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. A longer TTD indicates a better outcome | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to 24 months |
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| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to ~24 months |
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| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms. who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to ~24 months |
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| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score | 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. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to ~24 months |
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| Secondary | Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score | 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 is presented, defined as the time to first onset of a ≥10 point decrease from baseline. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to ~24 months |
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| Secondary | Time to True Deterioration (TTD) in EORTC Composite Symptom Score for Cough (QLQ-LC13 Item 31), Chest Pain (QLQ-LC13 Item 40), or Dyspnea (QLQ-C30 Item 8) | EORTC QLQ-C30 includes a single-item scale score for dyspnea (Item 8), the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, which includes a single-item scale score for cough (Item 31) and chest pain (Item 40). Time to True Deterioration for the Composite Endpoint of EORTC QLQ- LC13 Cough, EORTC QLQ- LC13 Chest Pain, or EORTC QLQ-C30 Dyspnea is presented, defined as the time to first onset of a ≥10-point decrease from baseline in any one of 3 scale items with confirmation by the subsequent visit of a 10 or more-point deterioration from baseline in the same scale as the first onset under right-censoring rule. | Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 and EORTC QLC-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to ~ 24 months |
|
Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
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 | Pembrolizumab + Lenvatinib | Participants received 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 is administered for up to 35 treatment cycles (~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity. | 161 | 185 | 99 | 181 | 170 | 181 |
| EG001 | Docetaxel | Participants received docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity. | 164 | 189 | 66 | 177 | 165 | 177 |
| EG002 | Lenvatinib | Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity. | 46 | 48 | 28 | 47 | 45 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypoaldosteronism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Anal inflammation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastric perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA 27.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Inadequate analgesia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gallbladder enlargement | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Delayed effects of radiation | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Autoimmune encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Encephalitis toxic | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Toxic leukoencephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jul 30, 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 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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 |
|
| Not Immediate Prior Therapy--Anti-PD-1/PD-L1 |
|
| TPS>=50% |
|
| Unknown |
|
| OG002 | Lenvatinib Monotherapy | Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity. |
|
|
|
| OG002 |
| Lenvatinib Monotherapy |
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity. |
|
|
|
| Docetaxel |
Participants received docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity. |
|
|
|
| OG002 | Lenvatinib Monotherapy | Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received docetaxel at 75 mg/m^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity. |
|
|
|