AzTrials
AzTrials

Lung NeoplasmsPhase 3NCT04380636

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

A Phase 3 study testing Pembrolizumab, Olaparib and Etoposide in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 205 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Olaparib and Etoposide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
870 participants
Where
205 sitesin 26 countries
Study dates
6 Jul 2020to 6 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 pathologically (histologically or cytologically) confirmed diagnosis of NSCLC
  • Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
  • Is unable to undergo surgery with curative intent for Stage III NSCLC
  • Has no evidence of metastatic disease indicating Stage IV NSCLC
  • Has measurable disease as defined by RECIST 1.1
  • Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible
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  • Has provided a tumor tissue sample (tissue biopsy [core, incisional, or excisional])
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
  • Has a life expectancy of at least 6 months
  • A male participant must agree to use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention unless confirmed to be azoospermic (vasectomized or secondary to medical cause). The length of time required to continue contraception for each study intervention is as follows: Olaparib, platinum doublet, and radiotherapy: 90 days
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees to abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Pembrolizumab: 120 days; Olaparib, platinum doublet, and radiotherapy: 180 days
  • Has a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Has adequate pulmonary function tests
  • Has adequate organ function
  • Has provided written informed consent

Who cannot join

  • Has small cell lung cancer or a mixed tumor with presence of small cell elements
  • Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
  • Has had documented weight loss >10% (from baseline) in the preceding 3 months
  • Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
  • Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  • Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
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  • Has had major surgery <4 weeks prior to the first dose of study treatment (except for placement of vascular access)
  • Is expected to require any other form of antineoplastic therapy, while on study
  • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
  • Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [GCSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
  • Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
  • Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days before, during, and for at least 2 days after administration of pemetrexed
  • Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study treatment
  • The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (excluding carcinoma-in situ-of the bladder) that have undergone potentially curative therapy
  • Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has 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 or known active Hepatitis C virus infection
  • Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
  • Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
  • 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 unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
  • Has had an allogenic tissue/solid organ transplant

Trial locations and contacts

205 sites in 26 countries.

205 sites in 26 countries

United States33 sites

  • Massachusetts General Hospital ( Site 0038)

    Boston, Massachusetts, 02114

  • Novant Health Presbyterian ( Site 0081)

    Charlotte, North Carolina, 28204

  • The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)

    Cincinnati, Ohio, 45219

  • Henry Ford Hospital ( Site 0045)

    Detroit, Michigan, 48202

  • Duke University Medical Center ( Site 0050)

    Durham, North Carolina, 27710

  • Fort Wayne Medical Oncology and Hematology ( Site 0094)

    Fort Wayne, Indiana, 46804

  • Parkview Research Center ( Site 0032)

    Fort Wayne, Indiana, 46845

  • St Joseph Heritage Healthcare-Oncology ( Site 0088)

    Fullerton, California, 92835

  • CHI Health St. Francis ( Site 0053)

    Grand Island, Nebraska, 68803

  • Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)

    Hollywood, Florida, 33021

  • St. Bernards Medical Center ( Site 0089)

    Jonesboro, Arkansas, 72401

  • Franciscan Health Lafayette East ( Site 0031)

    Lafayette, Indiana, 47905

  • University of Kentucky ( Site 0096)

    Lexington, Kentucky, 40536

  • Long Beach Memorial Medical Center ( Site 0006)

    Long Beach, California, 90806

  • UCLA Hematology/Oncology - Santa Monica ( Site 0013)

    Los Angeles, California, 90404

  • Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)

    Louisville, Kentucky, 40241

  • Miami VA Healthcare System ( Site 0024)

    Miami, Florida, 33125

  • University of South Alabama, Mitchell Cancer Institute ( Site 0003)

    Mobile, Alabama, 36604

  • Rutgers Cancer Institute of New Jersey ( Site 0054)

    New Brunswick, New Jersey, 08901

  • Mid Florida Hematology and Oncology Center ( Site 0022)

    Orange City, Florida, 32763

  • Orlando Health, UF Health Cancer Center Inc ( Site 0092)

    Orlando, Florida, 32806

  • Valley Health Systems - Ridgewood Campus ( Site 0056)

    Paramus, New Jersey, 07652

  • Fox Chase Cancer Center ( Site 0063)

    Philadelphia, Pennsylvania, 19111

  • Pikeville Medical Center ( Site 0036)

    Pikeville, Kentucky, 41501

  • St. Joseph Heritage Healthcare Local Lab ( Site 0011)

    Santa Rosa, California, 95403

  • Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)

    Seattle, Washington, 98108

  • Sanford Cancer Center Oncology Clinic ( Site 0066)

    Sioux Falls, South Dakota, 57104

  • Cancer Care Northwest ( Site 0074)

    Spokane Valley, Washington, 99216

  • VA St. Louis Health Care System ( Site 0047)

    St Louis, Missouri, 63106

  • Washington University Siteman Cancer Center ( Site 0046)

    St Louis, Missouri, 63110

  • Montefiore Einstein Center ( Site 0083)

    The Bronx, New York, 10467

  • Torrance Memorial Physician Network / Cancer Center ( Site 0093)

    Torrance, California, 90505

  • Piedmont Hematology-Oncology Associates ( Site 0080)

    Winston-Salem, North Carolina, 27103

Other trials in United States

China25 sites

  • Peking Union Medical College Hospital ( Site 3201)

    Beijing, Beijing Municipality, 100006

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital ( Site 3212)

    Beijing, Beijing Municipality, 100089

  • Beijing Cancer Hospital ( Site 3224)

    Beijing, Beijing Municipality, 130021

  • Jilin Cancer Hospital ( Site 3230)

    Changchun, Jilin, 130012

  • Xiangya Hospital of Central South University ( Site 3637)

    Changsha, Hunan, 410008

  • Second Xiangya Hospital of Central-South University ( Site 3227)

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital ( Site 3225)

    Changsha, Hunan, 410013

  • Hunan Cancer Hospital ( Site 3238)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University ( Site 3202)

    Chengdu, Sichuan, 510115

  • Daping Hospital,Third Military Medical University ( Site 3235)

    Chongqing, Chongqing Municipality, 400042

  • Fujian Provincial Cancer Hospital ( Site 3226)

    Fuzhou, Fujian, 350014

  • The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Nanchang University ( Site 3206)

    Nanchang, Jiangxi, 330006

  • Jiangsu Cancer Hospital ( Site 3234)

    Nanjing, Jiangsu, 210000

  • Shanghai Chest Hospital ( Site 3207)

    Shanghai, Shanghai Municipality, 200030

  • Zhongshan Hospital Fudan University ( Site 3220)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Pulmonary Hospital ( Site 3203)

    Shanghai, Shanghai Municipality, 200443

  • Peking University Shenzhen Hospital ( Site 3216)

    Shenzhen, Guangdong, 518036

  • Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)

    Shenzhen, Guangdong, 518116

  • Tianjin Medical University Cancer Institute & Hospital ( Site 3204)

    Tianjin, Tianjin Municipality, 300060

  • Wuhan Union Hospital Cancer Center ( Site 3222)

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital ( Site 3218)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University ( Site 3219)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital ( Site 3205)

    Zhengzhou, Henan, 450008

Other trials in China

Japan12 sites

  • National Hospital Organization Kyushu Cancer Center ( Site 3104)

    Fukuoka, 811-1395

  • Kansai Medical University Hospital ( Site 3103)

    Hirakata, Osaka, 573-1191

  • Kobe Minimally Invasive Cancer Center ( Site 3100)

    Kobe, Hyōgo, 650-0046

  • Kurume University Hospital ( Site 3112)

    Kurume, Fukuoka, 830-0011

  • Niigata Cancer Center Hospital ( Site 3109)

    Niigata, 951-8566

  • Osaka International Cancer Institute ( Site 3106)

    Osaka, 541-8567

  • Osaka Medical and Pharmaceutical University Hospital ( Site 3110)

    Takatsuki, Osaka, 569-8686

  • Juntendo University Hospital ( Site 3111)

    Tokyo, 113-0033

  • Tokyo Metropolitan Komagome Hospital ( Site 3108)

    Tokyo, 113-8677

  • Cancer Institute Hospital of JFCR ( Site 3107)

    Tokyo, 135-8550

  • Showa Medical University Hospital ( Site 3105)

    Tokyo, 142-8666

  • Kanagawa Cancer Center ( Site 3101)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Romania11 sites

  • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2500)

    Bucharest, Bucharest, 013823

  • Gral Medical SRL-Medical Oncology ( Site 2511)

    Bucharest, Bucharest, 031422

  • Spitalul Universitar de Urgenta Bucuresti ( Site 2508)

    Bucharest, Bucharest, 050098

  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)

    Cluj-Napoca, Cluj, 400015

  • S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)

    Comuna Floresti, Cluj, 407280

  • Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

    Constanța, 900591

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2510)

    Craiova, Dolj, 200746

  • Institutul Regional de Oncologie Iasi ( Site 2505)

    Iași, 700483

  • Radiology Therapeutic Center-Oncology ( Site 2502)

    Otopeni, Ilfov, 075100

  • S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)

    Timișoara, Timiș County, 300166

  • Policlinica Oncomed SRL ( Site 2504)

    Timișoara, Timiș County, 300239

Other trials in Romania

Germany9 sites

  • Zentralklinik Bad Berka GmbH ( Site 0905)

    Bad Berka, Thuringia, 99437

  • Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)

    Berlin, 13353

  • Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)

    Göttingen, Lower Saxony, 37075

  • LungenClinic Grosshansdorf GmbH ( Site 0901)

    Großhansdorf, Schleswig-Holstein, 22927

  • Katholisches Marienkrankenhaus gGmbH ( Site 0902)

    Hamburg, 22087

  • Universitaetsklinikum Jena ( Site 0911)

    Jena, Thuringia, 07747

  • Johannes Wesling Klinikum Minden ( Site 0908)

    Minden, North Rhine-Westphalia, 32429

  • GEHO Muenster ( Site 0910)

    Münster, North Rhine-Westphalia, 48153

  • Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)

    Neuss, North Rhine-Westphalia, 41462

Other trials in Germany

South Korea9 sites

  • Chungbuk National University Hospital ( Site 2802)

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 2807)

    Daegu, Taegu-Kwangyokshi, 42601

  • National Cancer Center ( Site 2800)

    Goyang-si, Kyonggi-do, 10408

  • Gyeongsang National University Hospital ( Site 2804)

    Jinju, Kyongsangnam-do, 52727

  • Seoul National University Bundang Hospital ( Site 2801)

    Seongnam-si, Kyonggi-do, 13620

  • Kangbuk Samsung Hospital ( Site 2806)

    Seoul, 03181

  • Severance Hospital Yonsei University Health System ( Site 2808)

    Seoul, 03722

  • The Catholic University of Korea St. Vincent s Hospital ( Site 2805)

    Suwon, Kyonggi-do, 16247

  • Ajou University Hospital ( Site 2803)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Czechia8 sites

  • Masarykuv onkologicky ustav ( Site 2206)

    Brno, Brno-mesto, 656 53

  • Krajska nemocnice Liberec, a.s. ( Site 2209)

    Liberec, 468 63

  • Nemocnice Na Plesi s.r.o. ( Site 2202)

    Nová Ves pod Pleší, Pribram, 262 04

  • Fakultni nemocnice Ostrava ( Site 2201)

    Ostrava, Ostrava Mesto, 708 52

  • Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)

    Prague, Praha 10, 100 34

  • Fakultni nemocnice v Motole ( Site 2210)

    Prague, Praha 5, 150 006

  • Vseobecna fakultni nemocnice v Praze ( Site 2208)

    Prague, 128 08

  • Nemocnice Na Bulovce ( Site 2205)

    Prague, 180 81

Other trials in Czechia

France8 sites

  • Clinique de l'Europe-Service de pneumologie ( Site 0816)

    Amiens, Somme, 80000

  • Hopital Avicenne ( Site 0803)

    Bobigny, Seine-Saint-Denis, 93000

  • C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 0806)

    Brest, Brittany Region, 29200

  • Centre Hospitalier Annecy Genevois ( Site 0811)

    Epagny Metz Tessy, Haute-Savoie, 74730

  • CHD Vendee ( Site 0807)

    La Roche-sur-Yon, Vendee, 85925

  • Clinique Clairval ( Site 0802)

    Marseille, Bouches-du-Rhone, 13009

  • H.I.A. Sainte-Anne ( Site 0815)

    Toulon, Var, 83800

  • Clinique Teissier Groupe ( Site 0808)

    Valenciennes, Nord, 59304

Other trials in France

Italy8 sites

  • Azienda Ospedaliero Universitaria Careggi ( Site 1001)

    Florence, 50134

  • Azienda Ospedaliera Vito Fazzi ( Site 1003)

    Lecce, 73100

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)

    Milan, 20133

  • Policlinico di Modena ( Site 1007)

    Modena, 41124

  • Policlinico Agostino Gemelli ( Site 1002)

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas Research Hospital ( Site 1000)

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera Umberto I- Torrette ( Site 1009)

    Torrette, Ancona, 60126

  • A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)

    Udine, 33100

Other trials in Italy

Russia8 sites

  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1911)

    Kazan', Tatarstan, Respublika, 420029

  • MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)

    Moscow, Moscow, 125284

  • Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Medical institute named after Berezin Sergey ( Site 1906)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)

    Yaroslavl, Yaroslavl Oblast, 150054

  • Sverdlovsk Regional Oncology Hospital ( Site 1909)

    Yekaterinburg, Sverdlovsk Oblast, 620036

Other trials in Russia

Ukraine8 sites

  • Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 2109)

    Antonivka Village, Kherson Oblast, 73000

  • Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

    Dnipro, Dnipropetrovsk Oblast, 49055

  • Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

    Kapitanivka Village, Kyivska Oblast, 08111

  • SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology ( Site 2110)

    Kharkiv, Kharkiv Oblast, 61024

  • LLC Ukrainian Center of Tomotherapy ( Site 2105)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

  • SNPE National Cancer Institute ( Site 2101)

    Kyiv, Kyivska Oblast, 03022

  • Medical Center Verum ( Site 2106)

    Kyiv, Kyivska Oblast, 03039

  • Kyiv City Clinical Oncology Center ( Site 2100)

    Kyiv, 03115

Other trials in Ukraine

Spain7 sites

  • H.U. Vall de Hebron ( Site 1201)

    Barcelona, 08035

  • Hospital Clinic de Barcelona ( Site 1204)

    Barcelona, 08036

  • Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)

    Majadahonda, Madrid, 28222

  • H.R.U Malaga - Hospital General ( Site 1206)

    Málaga, Malaga, 29011

  • Hospital Universitario Quiron Madrid ( Site 1200)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen Macarena ( Site 1205)

    Seville, 41009

  • Hospital Universitario La Fe ( Site 1203)

    Valencia, 46026

Other trials in Spain

United Kingdom7 sites

  • Leeds Teaching Hospitals NHS Trust ( Site 1401)

    Leeds, LS9 7TF

  • Guys and St Thomas NHS Foundation Trust ( Site 1410)

    London, London, City of, SE1 9RT

  • Royal Marsden Hospital (Sutton) ( Site 1407)

    London, Surrey, SM3 5PT

  • University College Hospital NHS Foundation Trust ( Site 1403)

    London-Camden, London, City of, NW1 2PG

  • Christie NHS Foundation Trust ( Site 1409)

    Manchester, M20 4BX

  • Weston Park Hospital ( Site 1406)

    Sheffield, Derbyshire, S10 2SJ

  • Southampton General Hospital ( Site 1400)

    Southampton, Worcestershire, SO16 6YD

Other trials in United Kingdom

Peru6 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)

    Arequipa, Ariqipa, 04001

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)

    Lima, 15036

  • Oncosalud ( Site 0605)

    Lima, 15036

  • Clinica San Gabriel ( Site 0601)

    Lima, 15088

  • Hospital Nacional Cayetano Heredia ( Site 0602)

    Lima, 15102

  • Detecta Clínica ( Site 0607)

    Surquillo, Muni Metro de Lima, 15038

Other trials in Peru

Turkey (Türkiye)6 sites

  • Ankara Bilkent Sehir Hastanesi ( Site 2002)

    Ankara, Adana, 06800

  • Memorial Ankara Hastanesi ( Site 2006)

    Ankara, 06520

  • Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)

    Istanbul, 34098

  • Medipol Universite Hastanesi ( Site 2003)

    Istanbul, 34214

  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)

    Istanbul, 34722

  • Ege University Medical Faculty ( Site 2005)

    Izmir, 35100

Other trials in Turkey (Türkiye)

Canada5 sites

  • Queen Elizabeth II Health Sciences Centre ( Site 0100)

    Halifax, Nova Scotia, B3H 1V7

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)

    Montreal, Quebec, H2X 0A9

  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)

    Montreal, Quebec, H3T 1M5

  • McGill University Health Center - Research Institute ( Site 0114)

    Montreal, Quebec, H4A 3J1

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0110)

    Québec, Quebec, G1J 1Z4

Other trials in Canada

Chile5 sites

  • Bradford Hill Norte ( Site 0204)

    Antofagasta, 1240000

  • OrlandiOncologia ( Site 0201)

    Providencia, Region M. de Santiago, 7500713

  • Bradfordhill ( Site 0200)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigación del Cáncer James Lind ( Site 0202)

    Temuco, Araucania, 4800827

  • Oncocentro ( Site 0203)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Hungary5 sites

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)

    Budapest, 1121

  • Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)

    Budapest, 1121

  • Petz Aladar Megyei Oktato Korhaz ( Site 2306)

    Győr, Győr-Moson-Sopron, 9024

  • Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)

    Gyula, Bekes County, 5700

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)

    Kecskemét, Bács-Kiskun county, 6000

Other trials in Hungary

Norway5 sites

  • Vestre Viken HF Drammen Sykehus ( Site 1101)

    Drammen, Buskerud, 3004

  • Sykehuset Oestfold ( Site 1107)

    Grålum, Østfold fylke, 1714

  • Akershus Universitetssykehus HF ( Site 1106)

    Lorenskog, Akershus, 1478

  • Oslo Universitetssykehus HF. Ulleval ( Site 1100)

    Oslo, 0450

  • Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)

    Stavanger, Rogaland, 4011

Other trials in Norway

Mexico4 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)

    Guadalajara, Jalisco, 44280

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)

    Monterrey, Nuevo León, 64460

  • CLIMERS Clinical Medical Research ( Site 0506)

    Orizaba, Veracruz, 94300

  • Instituto Nacional de Cancerologia ( Site 0502)

    Tlalpan, 14080

Other trials in Mexico

Poland4 sites

  • Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)

    Gdynia, Pomeranian Voivodeship, 81-519

  • SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)

    Siedlce, Masovian Voivodeship, 08-110

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2402)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Thailand4 sites

  • Chulalongkorn University ( Site 3003)

    Bangkok, Bangkok, 10330

  • Ramathibodi Hospital. ( Site 3000)

    Bangkok, Bangkok, 10400

  • Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)

    Chiang Mai, 50200

  • Srinagarind Hospital. Khon Kaen University ( Site 3002)

    Khon Kaen, 40002

Other trials in Thailand

Argentina2 sites

  • Clinica Adventista Belgrano-Oncology ( Site 4002)

    Caba., Buenos Aires, C1430EGF

  • Instituto Médico Río Cuarto ( Site 4003)

    Río Cuarto, Córdoba Province, X5800AEV

Other trials in Argentina

Estonia2 sites

  • North Estonia Medical Centre Foundation ( Site 1601)

    Tallinn, Harju, 13419

  • Tartu University Hospital ( Site 1600)

    Tartu, Tartu, 50406

Other trials in Estonia

Latvia2 sites

  • Pauls Stradins Clinical University Hospital ( Site 1501)

    Riga, 1002

  • Riga East Clinical University Hospital ( Site 1500)

    Riga, 1079

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)

    Kaunas, Kaunas County, 50161

  • National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)

    Vilnius, Vilniaus Miestas, 08660

Other trials in Lithuania

About this study

Official title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

  1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
  2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS
Being tested
Pembrolizumab, Olaparib, Placebo for olaparib, Etoposide, Carboplatin
Keywords
Programmed Cell Death Receptor 1 (PD-1, PD1), Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1), Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2), polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, 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 KEYTRUDA®, MK-3475

    intravenous (IV) infusion

  • OlaparibDrug

    Also called LYNPARZA®, MK-7339, AZD2281, KU-0059436

    oral tablets

  • Placebo for olaparibDrug

    oral tablets

  • EtoposideDrug

    Also called VEPESID®

    IV infusion

  • CarboplatinDrug

    Also called PARAPLATIN®

    IV infusion

  • CisplatinDrug

    Also called PLATINOL®

    IV infusion

  • PaclitaxelDrug

    Also called TAXOL®

    IV infusion

  • PemetrexedDrug

    Also called ALIMTA®

    IV infusion

  • Thoracic RadiotherapyRadiation

    external beam radiation

  • DurvalumabDrug

    Also called IMFINZI®

    IV infusion

Study groups in NCT04380636
Study groupRoleWhat they receive
pembrolizumab+chemoradiation→pembrolizumab+olaparib placeboExperimentalParticipants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.
Receives: Biological: Pembrolizumab; Drug: Placebo for olaparib; Drug: Etoposide; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed; Radiation: Thoracic Radiotherapy
pembrolizumab+chemoradiation→pembrolizumab+olaparibExperimentalParticipants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.
Receives: Biological: Pembrolizumab; Drug: Olaparib; Drug: Etoposide; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed; Radiation: Thoracic Radiotherapy
chemoradiation→durvalumabActive comparatorParticipants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.
Receives: Drug: Etoposide; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed; Radiation: Thoracic Radiotherapy; Drug: Durvalumab

What is being measured

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

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 48 months

  2. Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: Up to approximately 72 months

Secondary outcomes (16)

  1. Incidence of Adverse Events (AE)

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 72 months

  2. Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)

    An AE is defined as as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 72 months

  3. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of participants who have achieved a Complete Response (CR) or a Partial Response (PR).

    Measured: Up to approximately 72 months

  4. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    DOR is defined as the time from first documented evidence of Complete Response (CR) or a Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 72 months

  5. Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scale scores will be presented.

    Measured: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)

  6. Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score

    The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough scale score will be presented.

    Measured: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)

  7. Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score

    The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain scale score will be presented.

    Measured: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)

  8. Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). Participant responses to the question "Were you short of breath? are scored on a 4-point scale (1=not at all to 4=very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea scale score will be presented.

    Measured: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)

  9. Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning 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]. Participant responses are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life. The change from baseline in the EORTC QLQ-C30 physical functioning scale score will be presented.

    Measured: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)

  10. Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life. The change from baseline in the EORTC QLQ-C30 role functioning scale score will be presented.

    Measured: Baseline (at randomization) and at the end of study (approximately 72 months post randomization)

  11. Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score

    TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 29 and 30 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

    Measured: Up to approximately 72 months post randomization

  12. TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score

    TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 1 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.

    Measured: Up to approximately 72 months post randomization

  13. TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score

    TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 10 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.

    Measured: Up to approximately 72 months post randomization

  14. TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score

    TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Item 8 scale score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). Participant responses to the question "Were you short of breath? are scored on a 4-point scale (1=not at all to 4=very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.

    Measured: Up to approximately 72 months post randomization

  15. TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

    TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 1-5 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning 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]. Participant responses are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.

    Measured: Up to approximately 72 months post randomization

  16. TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score

    TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 6-7 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.

    Measured: Up to approximately 72 months post randomization

Timeline

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

  1. First posted8 May 2020
  2. Study start6 Jul 2020
  3. Primary completion5 May 2027 (estimated)
  4. Study completion6 Jul 2029 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
870 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04380636
Sponsor's protocol ID
7339-012
Other IDs
MK-7339-012, KEYLYNK-012, 205352, 2023-503591-25-00, U1111-1287-5477, 2019-003237-41, 2019, 2023
Status last verified
May 2026
First submitted
5 May 2020
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Jabbour SK, Cho BC, Bria E, Kato T, Bhosle J, Gainor JF, Reguart N, Wang L, Morgensztern D, Shentu Y, Kim SJ, Souza F, Reck M. Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Sep;23(6):e342-e346. doi: 10.1016/j.cllc.2022.04.003. Epub 2022 Apr 29.

    PubMed 35618629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Olaparib and Etoposide in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 205 sites in 26 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 16 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, China, Japan, Romania, Germany and 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 48 months). The study lists 2 primary outcomes in all. 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 NCT04380636, 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 15 May 2026.

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