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Lung cancer study matches drug cocktails to tumor markers

NCT ID NCT03516981

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether matching drug combinations to specific biomarkers in advanced non-small cell lung cancer could improve response. 245 patients who had not received prior treatment were grouped by two biomarkers (GEP and TMB) and given pembrolizumab plus another drug. The goal was to see if response rates met pre-set targets for each biomarker group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

245 people

The number who actually took part.

Started

Oct 2018

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced non-small cell lung cancer

Contacts and locations

Locations

  • AOU San Luigi Gonzaga di Orbassano ( Site 0707)

    Orbassano, Torino, 10043, Italy

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

    Legnago, Verona, 37045, Italy

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

    Tempe, Arizona, 85284, United States

  • Asan Medical Center ( Site 0801)

    Songpa-gu, Seoul, 05505, South Korea

  • Azienda Ospedaliera Papardo ( Site 0706)

    Messina, 98158, Italy

  • Azienda Ospedaliera Universitaria Senese ( Site 0705)

    Siena, 53100, Italy

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

    Blacktown, New South Wales, 2148, Australia

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

    Omsk, Omsk Oblast, 644013, Russia

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

    Montreal, Quebec, H3T 1M5, Canada

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

    Chicoutimi, Quebec, G7H 5H6, Canada

  • Cambridge University Hospitals NHS Trust ( Site 1306)

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Cape Town Oncology Trials Pty Ltd ( Site 2312)

    Kraaifontein, Western Cape, 7570, South Africa

  • Derriford Hospital ( Site 1301)

    Plymouth, PL6 8DH, United Kingdom

  • Dolnoslaskie Centrum Onkologii. ( Site 0993)

    Wroclaw, Lower Silesian Voivodeship, 53-413, Poland

  • Emily Couric Clinical Cancer Center ( Site 0134)

    Charlottesville, Virginia, 22903, United States

  • Fiona Stanley Hospital ( Site 0201)

    Murdoch, Western Australia, 6150, Australia

  • Fondazione Policlinico Universitario A. Gemelli ( Site 0703)

    Roma, 00168, Italy

  • Gallipoli Medical Research Foundation ( Site 0202)

    Brisbane, Queensland, 4120, Australia

  • Hopitaux Universitaires de Geneve HUG ( Site 2106)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Hospital General Universitari Vall d Hebron ( Site 1100)

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 1102)

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal ( Site 1101)

    Madrid, 28034, Spain

  • Istituto Clinico Humanitas Research Hospital ( Site 0700)

    Rozzano, Lombardy, 20089, Italy

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

    Meldola, Emilia-Romagna, 47014, Italy

  • Jewish General Hospital ( Site 0307)

    Montreal, Quebec, H3T 1E2, Canada

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

    Hackensack, New Jersey, 07601, United States

  • Kantonsspital Graubuenden ( Site 2103)

    Chur, Kanton Graubünden, 7000, Switzerland

  • Kantonsspital St. Gallen ( Site 2102)

    Saint Gallen, Canton of Aargau, 9007, Switzerland

  • Kaohsiung Chang Gung Memorial Hospital ( Site 1203)

    Kaohsiung City, 83301, Taiwan

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

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • MPOC ( Site 2310)

    Groenkloof Pretoria, Gauteng, 0181, South Africa

  • Mayo Clinic Florida ( Site 0115)

    Jacksonville, Florida, 32224, United States

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

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center ( Site 0113)

    New York, New York, 10065, United States

  • Mid Western Cancer Centre ( Site 2201)

    Limerick, V94 YVH0, Ireland

  • N.N. Blokhin NMRCO ( Site 1000)

    Moscow, Moscow, 115478, Russia

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

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Center Hospital ( Site 2001)

    Tokyo, 104-0045, Japan

  • National Cancer Centre Singapore ( Site 1900)

    Singapore, Central Singapore, 169610, Singapore

  • National Cheng Kung University Hospital ( Site 1202)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 1200)

    Taipei, 10048, Taiwan

  • National University Hospital ( Site 1901)

    Singapore, South West, 119074, Singapore

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

    Vancouver, Washington, 98684, United States

  • Oncology Hematology Care ( Site 8005)

    Cincinnati, Ohio, 45242, United States

  • Prince of Wales Hospital ( Site 1801)

    Hong Kong, 000, Hong Kong

  • Princess Margaret Cancer Centre ( Site 0309)

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Mary Hospital ( Site 1800)

    Hong Kong, Hong Kong

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

    Ufa, Baskortostan, Respublika, 450054, Russia

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

    Kazan', Tatarstan, Respublika, 420029, Russia

  • SBHI Leningrad Regional Clinical Hospital ( Site 1001)

    Saint Petersburg, Sankt-Peterburg, 194291, Russia

  • Samsung Medical Center ( Site 0805)

    Seoul, 06351, South Korea

  • Sandton Oncology Medical Group PTY LTD ( Site 2316)

    Sandton, Gauteng, 2196, South Africa

  • Seconda Universita degli Studi di Napoli ( Site 0704)

    Naples, 80131, Italy

  • Seoul National University Bundang Hospital ( Site 0803)

    Seongnam-si, Kyonggi-do, 13620, South Korea

  • Seoul National University Hospital ( Site 0800)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 0802)

    Seoul, 03722, South Korea

  • St James Hospital ( Site 2200)

    Dublin, D08 K0Y5, Ireland

  • St Petersburg City Clinical Oncology Dispensary ( Site 1002)

    Saint Petersburg, Sankt-Peterburg, 198255, Russia

  • Sunnybrook Health Science Centre ( Site 0304)

    Toronto, Ontario, M4N 3M5, Canada

  • Taipei Veterans General Hospital ( Site 1204)

    Taipei, 11217, Taiwan

  • Texas Oncology-Memorial City ( Site 8006)

    Houston, Texas, 77024, United States

  • Texas Oncology-Tyler ( Site 8003)

    Tyler, Texas, 75702, United States

  • The Cancer Institute Hospital of JFCR ( Site 2000)

    Tokyo, 135-8550, Japan

  • The Loginov Moscow Clinical Scientific Center ( Site 1008)

    Moscow, Moscow, 111123, Russia

  • The Ottawa Hospital ( Site 0306)

    Ottawa, Ontario, K1H 8L6, Canada

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

    Santa Monica, California, 90404, United States

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

    Pittsburgh, Pennsylvania, 15232, United States

  • Umhlanga Oncolgy Center ( Site 2311)

    Umhlanga, KwaZulu-Natal, 4320, South Africa

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

    Pretoria, Gauteng, 0002, South Africa

  • Universitaetsspital Basel ( Site 2104)

    Basel, Canton of Basel-City, 4031, Switzerland

  • Universitaetsspital Zuerich ( Site 2100)

    Zurich, Canton of Zurich, 8091, Switzerland

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

    London, London, City of, NW1 2PG, United Kingdom

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

    Sacramento, California, 95817, United States

  • University of California San Francisco ( Site 0111)

    San Francisco, California, 94143, United States

  • University of Maryland ( Site 0136)

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania ( Site 0132)

    Philadelphia, Pennsylvania, 19104, United States

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

    Madison, Wisconsin, 53792, United States

  • Vaal Triangle Oncology Centre ( Site 2314)

    Vereeniging, Gauteng, 1939, South Africa

  • Weill Cornell Medical College ( Site 0138)

    New York, New York, 10065, United States

  • Wits Clinical Research ( Site 2313)

    Parktown-Johannesburg, Gauteng, 2193, South Africa

  • Yale University School of Medicine ( Site 0100)

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.