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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03829319




Registration number
NCT03829319
Ethics application status
Date submitted
1/02/2019
Date registered
4/02/2019
Date last updated
25/06/2024

Titles & IDs
Public title
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
Scientific title
A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)
Secondary ID [1] 0 0
MK-7902-006
Secondary ID [2] 0 0
7902-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonsquamous Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Placebo matching lenvatinib

Experimental: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib - Participants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m\^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily for up to 2 years.

Placebo comparator: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo - In Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily for up to 2 years.


Treatment: Other: Pembrolizumab
IV infusion Q3W

Treatment: Drugs: Carboplatin
IV infusion Q3W

Treatment: Drugs: Cisplatin
IV infusion Q3W

Treatment: Drugs: Pemetrexed
IV infusion Q3W

Treatment: Drugs: Lenvatinib
Oral capsule once daily

Treatment: Drugs: Placebo matching lenvatinib
Oral capsule once daily
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with a Dose-limiting Toxicity
Timepoint [1] 0 0
Cycle 1; each cycle is 21 days (up to 21 days)
Primary outcome [2] 0 0
Part 1: Number of Participants with One or More Adverse Events
Timepoint [2] 0 0
Through 90 days post last dose of study treatment (Up to approximately 27 months)
Primary outcome [3] 0 0
Number of Participants With Study Intervention Discontinuations Due to Adverse Events
Timepoint [3] 0 0
Up to approximately 24 months
Primary outcome [4] 0 0
Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ
Timepoint [4] 0 0
Up to approximately 36 months
Primary outcome [5] 0 0
Part 2: Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 47 months
Secondary outcome [1] 0 0
Part 2: Objective Response Rate (ORR) as Assessed by BICR according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ
Timepoint [1] 0 0
Up to approximately 19 months
Secondary outcome [2] 0 0
Part 2; Duration of Response (DOR) as Assessed by BICR according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ
Timepoint [2] 0 0
Up to approximately 19 months
Secondary outcome [3] 0 0
Part 2: Number of Participants with One or More Adverse Events
Timepoint [3] 0 0
Up to approximately 27 months
Secondary outcome [4] 0 0
Part 2: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Timepoint [4] 0 0
Up to approximately 24 months
Secondary outcome [5] 0 0
Part 2: Change from Baseline in Global Health Status/Quality of Life (QoL); Cough; Chest Pain; Dyspnea; and Physical Functioning
Timepoint [5] 0 0
Baseline (Cycle 1 Day 1) and at designated timepoints up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [6] 0 0
Part 2: Time to True Deterioration as Assessed by Change from Baseline in Global Health Status/Quality of Life; Cough; Chest Pain; Dyspnea; and Physical Functioning
Timepoint [6] 0 0
Baseline (Cycle 1 Day 1) and at designated timepoints up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
Secondary outcome [7] 0 0
Time to True Deterioration in the Composite Endpoint (Combination of Cough, Chest Pain, or Dyspnea)
Timepoint [7] 0 0
Baseline (Cycle 1 Day 1) and at designated timepoints up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC], nonsquamous NSCLC.
* Confirmation that Epidermal Growth Factor Receptor (EGFR), ALK Receptor Tyrosine Kinase (ALK), or ROS1 Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated as primary treatment (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a Kirsten Rat Sarcoma (KRAS) gene mutation).
* Have measurable disease based on RECIST 1.1. Note: Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the completion of radiation.
* Provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (not previously irradiated).
* Life expectancy of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study intervention but before randomization.
* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
* Male participants must agree for at least 7 days after the last dose of lenvatinib/matching placebo and up to 180 days after the last dose of chemotherapeutic agents to:

1. Refrain from donating sperm PLUS either:
2. Be abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
3. Must agree to use contraception unless confirmed to be azoopsermic (vasectomized or secondary to medical cause) as detailed below:

1. Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.

Note: 7 days after lenvatinib/matching placebo is stopped, if the participant is on pembrolizumab only and is greater than 180 days post chemotherapy, no male contraception measures are needed.

* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

1. Is not a WOCBP OR
2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab and/or 30 days post-lenvatinib/matching placebo, and up to 180 days post last dose of chemotherapeutic agents, whichever occurs last.
* Adequate organ function.
* 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 prior to randomization. Note: Participants must not have a history of uncontrolled or poorly-controlled hypertension, defined as >150/90 mm Hg for >4 weeks despite standard medical management.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, clinically stable, and have not required steroids for at least 14 days prior to the first dose of study intervention.
* History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
* Radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib-therapy. (In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta).
* Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. Note: The time requirement also does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
* Has had allogeneic tissue/solid organ transplant.
* Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
* Known history of Hepatitis B. No testing for Hepatitis B or Hepatitis C is required unless mandated by the local health authority.
* History of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral drug absorption.
* Active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior to the first dose of study intervention.
* Significant cardiovascular impairment within 12 months prior to the first dose of study intervention, including history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident (CVA)/stroke, or cardiac arrhythmia associated with hemodynamic instability.
* Known history of active tuberculosis.
* Active infection requiring systemic therapy.
* Has not recovered adequately from any toxicity and/or complication from major surgery prior to the first dose of study intervention.
* Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity to any component of lenvatinib or pembrolizumab, or as applicable, carboplatin, cisplatin, or pemetrexed.
* A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Has preexisting =Grade 3 gastrointestinal or non-gastrointestinal fistula.
* Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC.
* Received prior treatment with pembrolizumab or any other anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent, with lenvatinib or any other receptor tyrosine kinase inhibitor (RTKi), or with an agent directed to another stimulatory or co-inhibitory T cell receptor.
* Received radiotherapy within 14 days prior to the first dose of study intervention or received lung radiation therapy of >30 Gy within 6 months prior to the first dose of study intervention. Note: Participants must have recovered from all radiation-related toxicities to Grade =1, not required corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
* Received systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study intervention.
* Received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: killed vaccines are allowed.
* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
* History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
* Left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
Accrual to date
Final
761
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital Western Sydney Local Health District ( Site 0008) - Blacktown
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital ( Site 0001) - Port Macquarie
Recruitment hospital [3] 0 0
Chris OBrien Lifehouse ( Site 0006) - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital ( Site 0009) - Sydney
Recruitment hospital [5] 0 0
Cairns Hospital ( Site 0002) - Cairns
Recruitment hospital [6] 0 0
The Prince Charles Hospital ( Site 0010) - Chermside
Recruitment hospital [7] 0 0
Ballarat Health Services ( Site 0003) - Ballarat
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
4032 - Chermside
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
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Michigan
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United States of America
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Missouri
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New York
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United States of America
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North Dakota
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United States of America
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Santa Fe
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Cordoba
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Argentina
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San Juan
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Maule
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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Chile
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Antofagasta
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Guangdong
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China
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Heilongjiang
Country [34] 0 0
China
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Henan
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China
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Hubei
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China
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Jilin
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China
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Shanghai
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China
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Tianjin
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China
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Xinjiang
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China
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Zhejiang
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France
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Bas-Rhin
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France
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Bouches-du-Rhone
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France
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Hauts-de-Seine
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France
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Herault
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France
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Loire-Atlantique
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France
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Moselle
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France
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Rhone-Alpes
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France
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Rhone
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France
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Paris
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Germany
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Baden-Wurttemberg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Saarland
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Germany
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Sachsen-Anhalt
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Germany
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Schleswig-Holstein
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Germany
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Hamburg
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
State/province [60] 0 0
Jerusalem
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Israel
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Kfar Saba
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Israel
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Nazareth
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Zerifin
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ishikawa
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Japan
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Osaka
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Japan
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Niigata
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Japan
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Tokyo
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Japan
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Wakayama
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Korea, Republic of
State/province [74] 0 0
Chungbuk
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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New Zealand
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Bay Of Plenty
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New Zealand
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Auckland
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Poland
State/province [79] 0 0
Kujawsko-pomorskie
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Poland
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Lodzkie
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Poland
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Mazowieckie
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Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Leningradskaya Oblast
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Moskovskaya Oblast
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Moskva
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Nizhegorodskaya Oblast
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Omskaya Oblast
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Sankt-Peterburg
Country [90] 0 0
Russian Federation
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Tatarstan, Respublika
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
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Spain
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La Coruna
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Spain
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Las Palmas
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Spain
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Valenciana, Comunitat
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Spain
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Alicante
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Malaga
Country [98] 0 0
Spain
State/province [98] 0 0
Zaragoza
Country [99] 0 0
Turkey
State/province [99] 0 0
Adana
Country [100] 0 0
Turkey
State/province [100] 0 0
Ankara
Country [101] 0 0
Turkey
State/province [101] 0 0
Istanbul
Country [102] 0 0
Turkey
State/province [102] 0 0
Izmir
Country [103] 0 0
Turkey
State/province [103] 0 0
Malatya
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Cambridgeshire
Country [105] 0 0
United Kingdom
State/province [105] 0 0
London, City Of
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Scotland
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Leeds
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Leicester
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Manchester
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Nottingham
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.

The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.
Trial website
https://clinicaltrials.gov/study/NCT03829319
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03829319