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Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

Primary Purpose

Metastatic Non-Small Cell Lung Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Lenvatinib

Docetaxel

About this trial

This is an interventional treatment trial for Metastatic Non-Small Cell Lung Cancer focused on measuring programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), programmed cell death-ligand 2 (PD-L2, PDL2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c).
Has PD on treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
- Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
Has PD during/after platinum doublet chemotherapy for metastatic disease.
Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation).
Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor.
Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1, as determined by the local site assessment.
Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PD-L1], from the primary lesion or a metastatic lesion).
Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization.
Has a life expectancy of at least 3 months.
Male participants receiving pembrolizumab ± lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for ≥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:

Has received docetaxel as monotherapy or in combination with other therapies.
Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb.
Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy >30 Gy within 6 months before the first dose of study treatment.
Has received a live vaccine within 30 days before the first dose of study treatment.
Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment.
Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.
Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment.
Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment.
Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has severe hypersensitivity to pembrolizumab and/or any of its excipients.
Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of hepatitis B reactive or known active hepatitis C virus infection.
Has active tuberculosis.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 90 days (male participants) or 30 days (for female participants) after the last dose of docetaxel.
Has had an allogeneic tissue/solid organ transplant.

Sites / Locations

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)
Cancer Specialists of North Florida - Fleming Island ( Site 1675)
Mid-Florida Cancer Centers ( Site 1611)
University of Kentucky School of Medicine & Hospitals ( Site 1621)
Hematology Oncology Clinic ( Site 1680)
Harry & Jeanette Weinberg Cancer Institute ( Site 1626)
Medstar Good Samaritan Hospital ( Site 1625)
Massachusetts General Hospital ( Site 1622)
MGH - North Shore Cancer Center ( Site 1668)
The Mass General Cancer Center at Newton-Wellesley ( Site 1692)
University of Massachusetts Medical School ( Site 1693)
Billings Clinic ( Site 1631)
Bozeman Health Deaconness Cancer Center ( Site 1632)
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)
Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)
Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)
Memorial Sloan-Kettering Cancer Center ( Site 1661)
New York Cancer and Blood Specialists ( Site 1696)
University of Rochester ( Site 1638)
Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)
TriHealth Cancer Institute ( Site 1672)
MetroHealth Medical Center ( Site 1694)
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)
Fox Chase Cancer Center ( Site 1647)
Thompson Cancer Survival Center ( Site 1695)
Millenium Physicians ( Site 1690)
Instituto de Investigaciones Metabolicas ( Site 2004)
Hospital Britanico de Buenos Aires ( Site 2002)
Sanatorio Parque ( Site 2005)
Hospital Aleman ( Site 2000)
CEMIC ( Site 2003)
Blacktown Hospital ( Site 0004)
Port Macquarie Base Hospital ( Site 0003)
Westmead Hospital ( Site 0005)
Southern Medical Day Care Centre ( Site 0001)
Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)
Calvary Central Districts Hospital ( Site 0007)
Bendigo Cancer Centre ( Site 0008)
CancerCare Manitoba ( Site 1504)
Kingston Health Sciences Centre ( Site 1503)
London Regional Cancer Program - London HSC ( Site 1505)
Princess Margaret Cancer Centre ( Site 1502)
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)
Rodrigo Botero SAS ( Site 1300)
Clinica de la Costa Ltda. ( Site 1309)
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)
Oncomedica S.A. ( Site 1302)
Administradora Country SA - Clinica del Country ( Site 1307)
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)
Centro Medico Imbanaco de Cali S.A ( Site 1301)
CHU Caen Service de Pneumologie ( Site 0401)
HIA Percy-Clamart ( Site 0411)
ICO Centre Paul Papin ( Site 0412)
Clinique Ambroise Pare ( Site 0402)
Centre Hospitalier General - Avignon ( Site 0407)
Centre Hospitalier Le Mans ( Site 0406)
Institut Curie ( Site 0400)
Hopital Europeen Georges Pompidou ( Site 0408)
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)
Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)
SRH Wald-Klinikum Gera GmbH ( Site 0503)
Vivantes Klinikum Spandau ( Site 0505)
General Hospital of Chest Diseases "Sotiria" ( Site 1703)
Metropolitan Hospital-4th Oncology Dept ( Site 1700)
University Hospital of Ioannina ( Site 1701)
European Interbalkan Medical Center ( Site 1704)
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)
Petz Aladar Megyei Oktato Korhaz ( Site 0609)
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)
Tudogyogyintezet Torokbalint ( Site 0602)
Veszprem Megyei Tudogyogyintezet ( Site 0607)
Semmelweis Egyetem.. ( Site 0604)
Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)
Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)
Soroka Medical Center ( Site 0701)
Rambam Medical Center ( Site 0703)
Shaare Zedek Medical Center-Oncology ( Site 0706)
Meir Medical Center ( Site 0702)
Rabin Medical Center ( Site 0700)
Chaim Sheba Medical Center ( Site 0704)
Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)
Ospedale San Gerardo - ASST Monza ( Site 0804)
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)
A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)
Ospedale San Luigi Gonzaga ( Site 0802)
Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)
AOU Policlinico Vittorio Emanuele ( Site 0811)
Istituto Nazionale dei Tumori ( Site 0806)
Policlinico San Matteo - Fondazione IRCCS ( Site 0812)
Azienda Ospedaliera di Perugia ( Site 0805)
Kanagawa Cardiovascular and Respiratory Center ( Site 0105)
Sendai Kousei Hospital ( Site 0107)
Kansai Medical University Hospital ( Site 0104)
Chiba University Hospital ( Site 0106)
Niigata Cancer Center Hospital ( Site 0101)
National Cancer Center Hospital ( Site 0103)
The Cancer Institute Hospital of JFCR ( Site 0100)
Chungbuk National University Hospital ( Site 0201)
Seoul National University Bundang Hospital ( Site 0204)
Asan Medical Center ( Site 0203)
Severance Hospital Yonsei University Health System ( Site 0202)
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)
Hospital CUF Porto ( Site 1802)
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)
Hematology and Oncology Institute ( Site 2105)
Ad-Vance Medical Research LLC ( Site 2103)
Puerto Rico Medical Research Center LLC ( Site 2101)
GBUZ Republican Clinical Oncological Dispensary ( Site 0922)
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)
Central Clinical Hospital of the Administration of the President ( Site 0910)
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
SPb SBHI City Clinical Oncological Dispensary ( Site 0901)
Railway Hospital of OJSC ( Site 0907)
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)
GBUZ SPb CRPCstmc(o) ( Site 0921)
Pavlov First Saint Petersburg State Medical University ( Site 0917)
Hospital Central de Asturias ( Site 1002)
Consorci Hospitalari Mataro ( Site 1008)
Hospital Universitario Marques de Valdecilla ( Site 1003)
Hospital Universitario Insular de Gran Canaria ( Site 1011)
Hospital Universitario Puerta de Hierro ( Site 1007)
Hospital Universitario Quiron Madrid ( Site 1012)
Hospital Clinico de Valencia ( Site 1010)
Hospital Universitari Vall d Hebron ( Site 1004)
Hospital Ciudad de Jaen ( Site 1000)
Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)
Hospital Universitario 12 de Octubre ( Site 1006)
Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)
Nottingham City Hospital Campus ( Site 1105)
Leicester Royal Infirmary ( Site 1110)
North Middlesex University Hospital NHS Trust ( Site 1109)
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)
Mount Vernon Cancer Centre ( Site 1107)
Aberdeen Royal Infirmary ( Site 1114)
University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)
Birmingham Heartlands Hospital ( Site 1103)
St James s University Hospital ( Site 1106)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Pembrolizumab+Lenvatinib

Docetaxel

Lenvatinib Monotherapy

Arm Description

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.

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.

Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS is defined as the time from randomization to the date of death due to any cause.

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS will be assessed by blinded independent central review (BICR) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Secondary Outcome Measures

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR will be assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy

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 will be assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Number of Participants Experiencing an Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.

Number of Participants Discontinuing Study Treatment Due to an AE

The number of participants who discontinue study treatment due to an AE will be presented.

Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score

The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of cancer patients, including a combined global health status (GHS)/QoL (Items 29 and 30) scale. For each item, scores range from 0-100, with higher scores indicating higher GHS/QoL. Per protocol, scores for items 29 and 30 will be averaged to compute a combined GHS/QoL scale score. Change from baseline in the combined GHS/QoL scale score will be presented.

Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score

Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough (Item 31) scale score will be presented.

Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score

Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain (Item 40) scale score will be presented.

Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). For this item, individual responses to the question "Were you short of breath?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea (Item 8) scale score will be presented.

Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The PF scale consists of participant responses to 5 questions regarding performance of daily activities [1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet]. Overall PF scores range from 0 to 100, with a lower score indicating a better outcome. The change from Baseline in the EORTC QLQ-C30 PF (Items 1 to 5) scale combined score will be presented.

Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. The TTD in the combined GHS/QoL (Items 29 & 30) scale combined score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.

Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score

Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). The TTD in EORTC QLQ-LC13 cough (Item 31) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.

Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score

Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). The TTD in EORTC QLQ-LC13 chest pain (Item 40) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.

Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). The TTD in dyspnea (Item 8) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.

Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The TTD in PF (Items 1 to 5) scale combined score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.

Full Information

NCT ID

NCT03976375

First Posted

June 3, 2019

Last Updated

September 28, 2023

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03976375

Brief Title

Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

Official Title

A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 26, 2019 (Actual)

Primary Completion Date

August 11, 2023 (Actual)

Study Completion Date

February 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Non-Small Cell Lung Cancer

Keywords

programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), programmed cell death-ligand 2 (PD-L2, PDL2)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

422 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab+Lenvatinib

Arm Type

Experimental

Arm Description

Arm Title

Docetaxel

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Lenvatinib Monotherapy

Arm Type

Experimental

Arm Description

Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity.

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

MK-3475, KEYTRUDA®

Intervention Description

IV infusion of pembrolizumab at 200 mg

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Other Intervention Name(s)

MK-7902, E7080, LENVIMA®

Intervention Description

Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

TAXOTERE®

Intervention Description

IV infusion of docetaxel at 75 mg/m^2.

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization to the date of death due to any cause.

Time Frame

Up to ~48 months

Title

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Description

Time Frame

Up to ~36 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel

Description

Time Frame

Up to ~18 months

Title

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy

Description

Time Frame

Up to ~36 months

Title

Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Description

Time Frame

Up to ~48 months

Title

Number of Participants Experiencing an Adverse Event (AE)

Description

Time Frame

Up to ~48 months

Title

Number of Participants Discontinuing Study Treatment Due to an AE

Description

The number of participants who discontinue study treatment due to an AE will be presented.

Time Frame

Up to ~48 months

Title

Description

Time Frame

Baseline and Week 12

Title

Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score

Description

Time Frame

Baseline and Week 12

Title

Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score

Description

Time Frame

Baseline and Week 12

Title

Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

Description

Time Frame

Baseline and Week 12

Title

Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

Description

Time Frame

Baseline and Week 12

Title

Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score

Description

Time Frame

Up to ~48 months

Title

Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score

Description

Time Frame

Up to ~48 months

Title

Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score

Description

Time Frame

Up to ~48 months

Title

Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score

Description

Time Frame

Up to ~48 months

Title

Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

Description

Time Frame

Up to ~48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c). Has PD on treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment Has PD during/after platinum doublet chemotherapy for metastatic disease. Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation). Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor. Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1, as determined by the local site assessment. Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy [antiPD-1/PD-L1], from the primary lesion or a metastatic lesion). Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy [anti-PD-1/PD-L1] and before receiving a randomization number), of a tumor lesion not previously irradiated. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization. Has a life expectancy of at least 3 months. Male participants receiving pembrolizumab ± lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for ≥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: Has received docetaxel as monotherapy or in combination with other therapies. Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb. Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy >30 Gy within 6 months before the first dose of study treatment. Has received a live vaccine within 30 days before the first dose of study treatment. Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment. Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel. Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment. Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment. Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy. Has known active central nervous system metastases and/or carcinomatous meningitis. Has severe hypersensitivity to pembrolizumab and/or any of its excipients. Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel. Has an active autoimmune disease that has required systemic treatment in the past 2 years. Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B reactive or known active hepatitis C virus infection. Has active tuberculosis. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 90 days (male participants) or 30 days (for female participants) after the last dose of docetaxel. Has had an allogeneic tissue/solid organ transplant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Cancer Specialists of North Florida - Fleming Island ( Site 1675)

City

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

Mid-Florida Cancer Centers ( Site 1611)

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

University of Kentucky School of Medicine & Hospitals ( Site 1621)

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Hematology Oncology Clinic ( Site 1680)

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Medstar Good Samaritan Hospital ( Site 1625)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21239

Country

United States

Facility Name

Massachusetts General Hospital ( Site 1622)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

MGH - North Shore Cancer Center ( Site 1668)

City

Danvers

State/Province

Massachusetts

ZIP/Postal Code

01923

Country

United States

Facility Name

The Mass General Cancer Center at Newton-Wellesley ( Site 1692)

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02462

Country

United States

Facility Name

University of Massachusetts Medical School ( Site 1693)

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Billings Clinic ( Site 1631)

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Bozeman Health Deaconness Cancer Center ( Site 1632)

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59715

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center ( Site 1661)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

New York Cancer and Blood Specialists ( Site 1696)

City

Port Jefferson Station

State/Province

New York

ZIP/Postal Code

11776

Country

United States

Facility Name

University of Rochester ( Site 1638)

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Facility Name

TriHealth Cancer Institute ( Site 1672)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Facility Name

MetroHealth Medical Center ( Site 1694)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Fox Chase Cancer Center ( Site 1647)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Thompson Cancer Survival Center ( Site 1695)

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37916

Country

United States

Facility Name

Millenium Physicians ( Site 1690)

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Instituto de Investigaciones Metabolicas ( Site 2004)

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Hospital Britanico de Buenos Aires ( Site 2002)

City

Buenos Aires

State/Province

Caba

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Sanatorio Parque ( Site 2005)

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

Hospital Aleman ( Site 2000)

City

Buenos Aires

ZIP/Postal Code

C1118AAT

Country

Argentina

Facility Name

CEMIC ( Site 2003)

City

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Blacktown Hospital ( Site 0004)

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Port Macquarie Base Hospital ( Site 0003)

City

Port Macquarie

State/Province

New South Wales

ZIP/Postal Code

2444

Country

Australia

Facility Name

Westmead Hospital ( Site 0005)

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Southern Medical Day Care Centre ( Site 0001)

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Calvary Central Districts Hospital ( Site 0007)

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Bendigo Cancer Centre ( Site 0008)

City

Bendigo

State/Province

Victoria

ZIP/Postal Code

3552

Country

Australia

Facility Name

CancerCare Manitoba ( Site 1504)

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Kingston Health Sciences Centre ( Site 1503)

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

London Regional Cancer Program - London HSC ( Site 1505)

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Princess Margaret Cancer Centre ( Site 1502)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1M5

Country

Canada

Facility Name

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Rodrigo Botero SAS ( Site 1300)

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050030

Country

Colombia

Facility Name

Clinica de la Costa Ltda. ( Site 1309)

City

Barranquilla

State/Province

Atlantico

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)

City

Valledupar

State/Province

Cesar

ZIP/Postal Code

200001

Country

Colombia

Facility Name

Oncomedica S.A. ( Site 1302)

City

Monteria

State/Province

Cordoba

ZIP/Postal Code

230001

Country

Colombia

Facility Name

Administradora Country SA - Clinica del Country ( Site 1307)

City

Bogota

State/Province

Distrito Capital De Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)

City

Bogota

State/Province

Distrito Capital De Bogota

ZIP/Postal Code

110311

Country

Colombia

Facility Name

Centro Medico Imbanaco de Cali S.A ( Site 1301)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760042

Country

Colombia

Facility Name

CHU Caen Service de Pneumologie ( Site 0401)

City

Caen

State/Province

Calvados

ZIP/Postal Code

14033

Country

France

Facility Name

HIA Percy-Clamart ( Site 0411)

City

Clamart

State/Province

Hauts-de-Seine

ZIP/Postal Code

92140

Country

France

Facility Name

ICO Centre Paul Papin ( Site 0412)

City

Angers

State/Province

Maine-et-Loire

ZIP/Postal Code

49100

Country

France

Facility Name

Clinique Ambroise Pare ( Site 0402)

City

Beuvry

State/Province

Pas-de-Calais

ZIP/Postal Code

62660

Country

France

Facility Name

Centre Hospitalier General - Avignon ( Site 0407)

City

Avignon

State/Province

Provence-Alpes-Cote-d Azur

ZIP/Postal Code

84000

Country

France

Facility Name

Centre Hospitalier Le Mans ( Site 0406)

City

Le Mans

State/Province

Sarthe

ZIP/Postal Code

72037

Country

France

Facility Name

Institut Curie ( Site 0400)

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Hopital Europeen Georges Pompidou ( Site 0408)

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

City

Heidelberg

State/Province

Baden-Wurttemberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

City

Hamm

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

59063

Country

Germany

Facility Name

SRH Wald-Klinikum Gera GmbH ( Site 0503)

City

Gera

State/Province

Thuringen

ZIP/Postal Code

07548

Country

Germany

Facility Name

Vivantes Klinikum Spandau ( Site 0505)

City

Berlin

ZIP/Postal Code

13585

Country

Germany

Facility Name

General Hospital of Chest Diseases "Sotiria" ( Site 1703)

City

Athens

State/Province

Attiki

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Metropolitan Hospital-4th Oncology Dept ( Site 1700)

City

Athens

State/Province

Attiki

ZIP/Postal Code

185 47

Country

Greece

Facility Name

University Hospital of Ioannina ( Site 1701)

City

Ioannina

ZIP/Postal Code

455 00

Country

Greece

Facility Name

European Interbalkan Medical Center ( Site 1704)

City

Thessaloniki

ZIP/Postal Code

570 01

Country

Greece

Facility Name

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

City

Szekesfehervar

State/Province

Fejer

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Petz Aladar Megyei Oktato Korhaz ( Site 0609)

City

Gyor

State/Province

Gyor-Moson-Sopron

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)

City

Szolnok

State/Province

Jasz-Nagykun-Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

Tudogyogyintezet Torokbalint ( Site 0602)

City

Torokbalint

State/Province

Pest

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Veszprem Megyei Tudogyogyintezet ( Site 0607)

City

Farkasgyepu

State/Province

Veszprem

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Semmelweis Egyetem.. ( Site 0604)

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Soroka Medical Center ( Site 0701)

City

Beer Sheva

ZIP/Postal Code

8410101

Country

Israel

Facility Name

Rambam Medical Center ( Site 0703)

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

Shaare Zedek Medical Center-Oncology ( Site 0706)

City

Jerusalem

ZIP/Postal Code

9013102

Country

Israel

Facility Name

Meir Medical Center ( Site 0702)

City

Kfar-Saba

ZIP/Postal Code

4428132

Country

Israel

Facility Name

Rabin Medical Center ( Site 0700)

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Chaim Sheba Medical Center ( Site 0704)

City

Ramat Gan

ZIP/Postal Code

5262000

Country

Israel

Facility Name

Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Ospedale San Gerardo - ASST Monza ( Site 0804)

City

Monza

State/Province

Monza E Brianza

ZIP/Postal Code

20900

Country

Italy

Facility Name

Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)

City

Rome

State/Province

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90146

Country

Italy

Facility Name

Ospedale San Luigi Gonzaga ( Site 0802)

City

Orbassano

State/Province

Torino

ZIP/Postal Code

10043

Country

Italy

Facility Name

Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

City

Avellino

ZIP/Postal Code

83100

Country

Italy

Facility Name

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

AOU Policlinico Vittorio Emanuele ( Site 0811)

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Istituto Nazionale dei Tumori ( Site 0806)

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Azienda Ospedaliera di Perugia ( Site 0805)

City

Perugia

ZIP/Postal Code

06132

Country

Italy

Facility Name

Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0051

Country

Japan

Facility Name

Sendai Kousei Hospital ( Site 0107)

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

980-0873

Country

Japan

Facility Name

Kansai Medical University Hospital ( Site 0104)

City

Hirakata

State/Province

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

Chiba University Hospital ( Site 0106)

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Niigata Cancer Center Hospital ( Site 0101)

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

National Cancer Center Hospital ( Site 0103)

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

The Cancer Institute Hospital of JFCR ( Site 0100)

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Chungbuk National University Hospital ( Site 0201)

City

Cheongju si

State/Province

Chungbuk

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital ( Site 0204)

City

Seongnam-si

State/Province

Kyonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Asan Medical Center ( Site 0203)

City

Songpagu

State/Province

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Severance Hospital Yonsei University Health System ( Site 0202)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)

City

Lisboa

ZIP/Postal Code

1769-001

Country

Portugal

Facility Name

Hospital CUF Porto ( Site 1802)

City

Porto

ZIP/Postal Code

4100-180

Country

Portugal

Facility Name

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Hematology and Oncology Institute ( Site 2105)

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

Ad-Vance Medical Research LLC ( Site 2103)

City

Ponce

ZIP/Postal Code

00717

Country

Puerto Rico

Facility Name

Puerto Rico Medical Research Center LLC ( Site 2101)

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

City

Ufa

State/Province

Baskortostan, Respublika

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

City

Krasnoyarsk

State/Province

Krasnoyarskiy Kray

ZIP/Postal Code

660133

Country

Russian Federation

Facility Name

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

105094

Country

Russian Federation

Facility Name

Central Clinical Hospital of the Administration of the President ( Site 0910)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

City

Omsk

State/Province

Omskaya Oblast

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Railway Hospital of OJSC ( Site 0907)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

GBUZ SPb CRPCstmc(o) ( Site 0921)

City

Sankt- Peterburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Pavlov First Saint Petersburg State Medical University ( Site 0917)

City

St. Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Hospital Central de Asturias ( Site 1002)

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Consorci Hospitalari Mataro ( Site 1008)

City

Mataro

State/Province

Barcelona

ZIP/Postal Code

08304

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla ( Site 1003)

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Universitario Insular de Gran Canaria ( Site 1011)

City

Las Palmas de Gran Canaria

State/Province

Las Palmas

ZIP/Postal Code

35001

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro ( Site 1007)

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Universitario Quiron Madrid ( Site 1012)

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Hospital Clinico de Valencia ( Site 1010)

City

Valencia

State/Province

Valenciana, Comunitat

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hospital Universitari Vall d Hebron ( Site 1004)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Ciudad de Jaen ( Site 1000)

City

Jaen

ZIP/Postal Code

23007

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre ( Site 1006)

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)

City

Cottingham

State/Province

East Riding Of Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Nottingham City Hospital Campus ( Site 1105)

City

Nottingham

State/Province

England

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Leicester Royal Infirmary ( Site 1110)

City

Leicester

State/Province

Leicestershire

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

North Middlesex University Hospital NHS Trust ( Site 1109)

City

London

State/Province

London, City Of

ZIP/Postal Code

N18 1QX

Country

United Kingdom

Facility Name

Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Mount Vernon Cancer Centre ( Site 1107)

City

Northwood

State/Province

London, City Of

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Aberdeen Royal Infirmary ( Site 1114)

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

City

Coventry

State/Province

Warwickshire

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Birmingham Heartlands Hospital ( Site 1103)

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

St James s University Hospital ( Site 1106)

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

34409776

Citation

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.

Results Reference

derived

PubMed Identifier

33300372

Citation

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.

Results Reference

derived

Links:

URL

https://www.merckclinicaltrials.com/

Description

Merck Clinical Trials Information

URL

https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7902-008&&kw=7902-008

Description

Plain Language Summary

Learn more about this trial

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