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AzTrials

Advanced Non-Small Cell Lung CancerPhase 2NCT03516981

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

A Phase 2 study testing Pembrolizumab, Favezelimab and Lenvatinib in people with Advanced Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 81 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Pembrolizumab, Favezelimab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
81 sitesin 16 countries
Study dates
1 Oct 2018to 13 Jun 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histologically- or cytologically-confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v 8) NSCLC and has not had prior systemic therapy for advanced disease
  • Has confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), c-ros oncogene 1- (ROS1-), or B isoform of rapidly accelerated fibrosarcoma- (B-Raf-) directed therapy is not indicated as primary therapy (documentation of absence of tumor activating EGFR mutations, B-Raf mutations, ALK gene rearrangements, and ROS1 gene rearrangements)
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
  • Male participants must agree to use contraception during the treatment period and for ≥120 days, after the last dose of study treatment and refrain from donating sperm during this period. Male participants with pregnant partners must agree to use a condom
  • Female participants eligible to participate if not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow contraceptive guidance during the treatment period and for ≥120 days after the last dose of study treatment
  • Provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Has adequate organ function

Who cannot join

  • Has significant cardiovascular impairment within 12 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability, significant cardiovascular impairment, or a left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram
  • Prolongation of QTc interval to >480 milliseconds (ms)
  • Has symptomatic ascites or pleural effusion
  • Has had an allogenic tissue/solid organ transplant
  • WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment
  • Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy, or has had major surgery within 3 weeks prior to first dose of study intervention
Show all 32Show fewer
  • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
  • Radiographic evidence of major blood vessel invasion/infiltration
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
  • Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC
  • Has current NSCLC disease that can be treated with curative intent with surgical resection, localized radiotherapy, or chemoradiation
  • Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor
  • Has received previous treatment with another agent targeting the Lymphocyte-activation gene 3 (LAG-3) receptor
  • Has received previous treatment with another agent targeting vascular endothelial growth factor (VEGF) or the VEGF receptor
  • Has received prior anticancer therapy including investigational agents within 4 weeks prior to randomization
  • Has received prior radiotherapy within 2 weeks of start of study treatment or received lung radiation therapy of >30 Gy within 6 months prior to the first dose of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study treatment
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, favezelimab, or lenvatinib and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating 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 120 days (females and males) after the last dose of study treatment.

Trial locations and contacts

81 sites in 16 countries.

81 sites in 16 countries

United States19 sites

  • University of Maryland ( Site 0136)

    Baltimore, Maryland, 21201

  • Emily Couric Clinical Cancer Center ( Site 0134)

    Charlottesville, Virginia, 22903

  • Oncology Hematology Care ( Site 8005)

    Cincinnati, Ohio, 45242

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0112)

    Hackensack, New Jersey, 07601

  • Texas Oncology-Memorial City ( Site 8006)

    Houston, Texas, 77024

  • Mayo Clinic Florida ( Site 0115)

    Jacksonville, Florida, 32224

  • University of Wisconsin- Madison Carbone Cancer Center ( Site 0130)

    Madison, Wisconsin, 53792

  • Yale University School of Medicine ( Site 0100)

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center ( Site 0113)

    New York, New York, 10065

  • Weill Cornell Medical College ( Site 0138)

    New York, New York, 10065

  • University of Pennsylvania ( Site 0132)

    Philadelphia, Pennsylvania, 19104

  • UPMC Cancer Center/Hillman Cancer Center ( Site 0104)

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic Rochester - St. Mary's Hospital ( Site 0117)

    Rochester, Minnesota, 55905

  • University of California Davis Comprehensive Cancer Center ( Site 0137)

    Sacramento, California, 95817

  • University of California San Francisco ( Site 0111)

    San Francisco, California, 94143

  • UCLA Hematology/Oncology -Santa Monica ( Site 0108)

    Santa Monica, California, 90404

  • Arizona Oncology Associates, PC- HAL ( Site 8001)

    Tempe, Arizona, 85284

  • Texas Oncology-Tyler ( Site 8003)

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C. ( Site 8000)

    Vancouver, Washington, 98684

Other trials in United States

Italy8 sites

  • AULSS21 Regione Veneto Ospedale Mater Salutis - Legnago ( Site 0701)

    Legnago, Verona, 37045

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0702)

    Meldola, Emilia-Romagna, 47014

  • Azienda Ospedaliera Papardo ( Site 0706)

    Messina, 98158

  • Seconda Universita degli Studi di Napoli ( Site 0704)

    Naples, 80131

  • AOU San Luigi Gonzaga di Orbassano ( Site 0707)

    Orbassano, Torino, 10043

  • Fondazione Policlinico Universitario A. Gemelli ( Site 0703)

    Roma, 00168

  • Istituto Clinico Humanitas Research Hospital ( Site 0700)

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera Universitaria Senese ( Site 0705)

    Siena, 53100

Other trials in Italy

Russia7 sites

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1005)

    Kazan', Tatarstan, Respublika, 420029

  • The Loginov Moscow Clinical Scientific Center ( Site 1008)

    Moscow, Moscow, 111123

  • N.N. Blokhin NMRCO ( Site 1000)

    Moscow, Moscow, 115478

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

    Omsk, Omsk Oblast, 644013

  • SBHI Leningrad Regional Clinical Hospital ( Site 1001)

    Saint Petersburg, Sankt-Peterburg, 194291

  • St Petersburg City Clinical Oncology Dispensary ( Site 1002)

    Saint Petersburg, Sankt-Peterburg, 198255

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1003)

    Ufa, Baskortostan, Respublika, 450054

Other trials in Russia

South Africa7 sites

  • MPOC ( Site 2310)

    Groenkloof Pretoria, Gauteng, 0181

  • Cape Town Oncology Trials Pty Ltd ( Site 2312)

    Kraaifontein, Western Cape, 7570

  • Wits Clinical Research ( Site 2313)

    Parktown-Johannesburg, Gauteng, 2193

  • Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2315)

    Pretoria, Gauteng, 0002

  • Sandton Oncology Medical Group PTY LTD ( Site 2316)

    Sandton, Gauteng, 2196

  • Umhlanga Oncolgy Center ( Site 2311)

    Umhlanga, KwaZulu-Natal, 4320

  • Vaal Triangle Oncology Centre ( Site 2314)

    Vereeniging, Gauteng, 1939

Other trials in South Africa

Canada6 sites

  • CIUSSS du Saguenay-Lac-St-Jean ( Site 0305)

    Chicoutimi, Quebec, G7H 5H6

  • Jewish General Hospital ( Site 0307)

    Montreal, Quebec, H3T 1E2

  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0310)

    Montreal, Quebec, H3T 1M5

  • The Ottawa Hospital ( Site 0306)

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Science Centre ( Site 0304)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0309)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

South Korea5 sites

  • Seoul National University Bundang Hospital ( Site 0803)

    Seongnam-si, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 0800)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 0802)

    Seoul, 03722

  • Samsung Medical Center ( Site 0805)

    Seoul, 06351

  • Asan Medical Center ( Site 0801)

    Songpa-gu, Seoul, 05505

Other trials in South Korea

Switzerland5 sites

  • Universitaetsspital Basel ( Site 2104)

    Basel, Canton of Basel-City, 4031

  • Kantonsspital Graubuenden ( Site 2103)

    Chur, Kanton Graubünden, 7000

  • Hopitaux Universitaires de Geneve HUG ( Site 2106)

    Geneva, Canton of Geneva, 1211

  • Kantonsspital St. Gallen ( Site 2102)

    Saint Gallen, Canton of Aargau, 9007

  • Universitaetsspital Zuerich ( Site 2100)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital ( Site 1203)

    Kaohsiung City, 83301

  • National Cheng Kung University Hospital ( Site 1202)

    Tainan, 704

  • National Taiwan University Hospital ( Site 1200)

    Taipei, 10048

  • Taipei Veterans General Hospital ( Site 1204)

    Taipei, 11217

Other trials in Taiwan

Australia3 sites

  • Blacktown Hospital Western Sydney Local Health District ( Site 0200)

    Blacktown, New South Wales, 2148

  • Gallipoli Medical Research Foundation ( Site 0202)

    Brisbane, Queensland, 4120

  • Fiona Stanley Hospital ( Site 0201)

    Murdoch, Western Australia, 6150

Other trials in Australia

Poland3 sites

  • MED-POLONIA Sp. z o.o. ( Site 0907)

    Poznan, Greater Poland Voivodeship, 60-693

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warsaw, Masovian Voivodeship, 02-781

  • Dolnoslaskie Centrum Onkologii. ( Site 0993)

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

Spain3 sites

  • Hospital General Universitari Vall d Hebron ( Site 1100)

    Barcelona, 08035

  • Hospital Universitario Ramon y Cajal ( Site 1101)

    Madrid, 28034

  • Hospital Universitario 12 de Octubre ( Site 1102)

    Madrid, 28041

Other trials in Spain

United Kingdom3 sites

  • Cambridge University Hospitals NHS Trust ( Site 1306)

    Cambridge, Cambridgeshire, CB2 0QQ

  • University College London Hospital NHS Foundation Trust ( Site 1308)

    London, London, City of, NW1 2PG

  • Derriford Hospital ( Site 1301)

    Plymouth, PL6 8DH

Other trials in United Kingdom

Hong Kong2 sites

  • Prince of Wales Hospital ( Site 1801)

    Hong Kong, 000

  • Queen Mary Hospital ( Site 1800)

    Hong Kong

Other trials in Hong Kong

Ireland2 sites

  • St James Hospital ( Site 2200)

    Dublin, D08 K0Y5

  • Mid Western Cancer Centre ( Site 2201)

    Limerick, V94 YVH0

Other trials in Ireland

Japan2 sites

  • National Cancer Center Hospital ( Site 2001)

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR ( Site 2000)

    Tokyo, 135-8550

Other trials in Japan

Singapore2 sites

  • National Cancer Centre Singapore ( Site 1900)

    Singapore, Central Singapore, 169610

  • National University Hospital ( Site 1901)

    Singapore, South West, 119074

Other trials in Singapore

About this study

Official title: A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

Read the detailed description

After Amendment 5, participants can receive 800 mg of favezelimab every 3 weeks (Q3W)

Being tested
Pembrolizumab, Favezelimab, Lenvatinib, Quavonlimab
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475

    200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W

  • FavezelimabBiological

    Also called MK-4280

    200 mg or 800 mg favezelimab solution for IV infusion administered Q3W

  • LenvatinibDrug

    Also called MK-7902

    20 mg lenvatinib capsules administered orally once daily

  • QuavonlimabDrug

    Also called MK-1308

    Quavonlimab solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)

Study groups in NCT03516981
Study groupRoleWhat they receive
Pembrolizumab + LenvatinibExperimentalParticipants received pembrolizumab 200 mg every 3 weeks (Q3W) intravenously (IV) plus lenvatinib 20 mg orally once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
Receives: Biological: Pembrolizumab; Drug: Lenvatinib
Pembrolizumab + QuavonlimabExperimentalParticipants received pembrolizumab 200 mg Q3W IV plus quavonlimab 25 mg every 6 weeks (Q6W) IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Receives: Biological: Pembrolizumab; Drug: Quavonlimab
Pembrolizumab + Favezelimab 200 mgExperimentalParticipants received pembrolizumab 200 mg Q3W IV plus favezelimab 200 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Receives: Biological: Pembrolizumab; Biological: Favezelimab
Pembrolizumab + Favezelimab 800 mgExperimentalParticipants received pembrolizumab 200 mg Q3W IV plus favezelimab 800 mg Q3W IV until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Receives: Biological: Pembrolizumab; Biological: Favezelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by local site radiologic review. The percentage of participants who experience CR or PR as assessed by local site radiologic review with confirmatory assessment per RECIST 1.1 is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.

    Measured: Up to approximately 80 months

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    PFS was defined as the time from allocation to the first documented progressive disease (PD) or death due to any cause, whichever occurs first according to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by local site radiologic review. PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS for all participants is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.

    Measured: Up to approximately 80 months

  2. Overall Survival (OS)

    OS was defined as the time from the date of allocation to death due to any cause. The OS for all participants is presented. Participants were assigned to 1 of 4 biomarker-defined groups (GEP low/TMB low, GEP low/TMB high, GEP high/TMB low, and GEP high/TMB high) and randomized within-group to receive a combination treatment of study interventions. Per protocol, no participants within GEP Low/TMB Low biomarker group were assigned to receive Pembrolizumab + Favezelimab 800 mg.

    Measured: Up to approximately 80 months

  3. Number of Participants Experiencing Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants in each treatment arm experiencing an AE is reported.

    Measured: Up to approximately 80 months

  4. Number of Participants Discontinuing Study Drug Due to AEs

    An AE was defined as any untoward medical occurrence in participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants in each treatment arm that discontinued study drug due to an AE is reported.

    Measured: Up to approximately 39 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2018
  2. Study start1 Oct 2018
  3. Primary completion13 Jun 2025
  4. Study completion13 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03516981
Sponsor's protocol ID
3475-495
Other IDs
MK-3475-495, 194621, KEYNOTE-495, 2022-500990-16-00, 2017-003134-85, 2017
Status last verified
May 2026
First submitted
27 Apr 2018
Last updated
8 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Gutierrez M, Lam WS, Hellmann MD, Gubens MA, Aggarwal C, Tan DSW, Felip E, Chiu JWY, Lee JS, Yang JC, Garon EB, Finocchiaro G, Ahn MJ, Luft A, Landers GA, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst RS. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. Nat Med. 2023 Jul;29(7):1718-1727. doi: 10.1038/s41591-023-02385-6. Epub 2023 Jul 10.

    PubMed 37429923

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Favezelimab and Lenvatinib in people with Advanced Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 81 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Italy, Russia, South Africa, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 80 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03516981, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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