Tutkimus atetsolitsumabista ja tiragolumabista verrattuna durvalumabiin potilailla, joilla on paikallisesti edennyt, ei-leikkausvaiheen III ei-pienisoluinen keuhkosyöpä (NSCLC) (SKYSCRAPER-03)
torstai 7. toukokuuta 2026 päivittänyt: Hoffmann-La Roche
Vaiheen III, avoin, satunnaistettu tutkimus atetsolitsumabista ja tiragolumabista verrattuna durvalumabiin potilailla, joilla on paikallisesti edennyt, ei-leikkausvaiheen III ei-pienisoluinen keuhkosyöpä, jotka eivät ole edenneet samanaikaisen platinapohjaisen kemosäteilyhoidon jälkeen
Tämän tutkimuksen tarkoituksena on arvioida atetsolitsumabin tehoa ja turvallisuutta yhdessä tiragolumabin kanssa verrattuna durvalumabiin osallistujilla, joilla on paikallisesti edennyt ei-leikkausvaiheen III ei-pienisoluinen keuhkosyöpä (NSCLC), jotka ovat saaneet vähintään kaksi sykliä samanaikaisesti platinahoitoa. kemoradioterapiaa (CRT) ja heillä ei ole ollut radiologista sairauden etenemistä.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
829
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
-
Amersfoort, Alankomaat, 3813 TZ
- Meander Medisch Centrum
-
Breda, Alankomaat, 4819 EV
- Amphia Ziekenhuis
-
Leidschendam, Alankomaat, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
-
Sittard-Geleen, Alankomaat, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
-
-
-
-
-
Buenos Aires, Argentiina, C1431FWO
- CEMIC
-
Ciudad Autonoma Buenos Aires, Argentiina, C1284AEB
- Hospital Británico de Buenos Aires
-
Córdoba, Argentiina, X5004FHP
- Clínica Universitaria Reina Fabiola
-
Rosario, Argentiina, S2000QGB
- Sanatorio Parque S.A.
-
-
-
-
New South Wales
-
Blacktown, New South Wales, Australia, 2148
- Blacktown Hospital
-
Campbelltown, New South Wales, Australia, 2560
- Macarthur Cancer Therapy Centre
-
Kogarah, New South Wales, Australia, 2217
- St George Hospital
-
-
South Australia
-
Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
-
-
Victoria
-
Victoria, Victoria, Australia, 3168
- Monash Health Translational Precinct
-
-
Western Australia
-
Bull Creek, Western Australia, Australia, 6149
- Fiona Stanley Hospital
-
-
-
-
-
Charleroi, Belgia, 6000
- GHdC Site Les Viviers
-
Ghent, Belgia, 9000
- AZ Maria Middelares
-
Hasselt, Belgia, 3500
- Jessa Zkh (Campus Virga Jesse)
-
-
-
-
Ceará
-
Fortaleza, Ceará, Brasilia, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
-
-
Paraná
-
Curitiba, Paraná, Brasilia, 80810-050
- Centro Integrado de Oncologia de Curitiba
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, Brasilia, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
-
Porto Alegre, Rio Grande do Sul, Brasilia, 90610-000
- Hospital Sao Lucas - PUCRS
-
-
São Paulo
-
Barretos, São Paulo, Brasilia, 14784-400
- Hospital de Cancer de Barretos
-
São José do Rio Preto, São Paulo, Brasilia, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
-
São Paulo, São Paulo, Brasilia, 01246-000
- Instituto do Câncer do Estado de São Paulo - ICESP
-
-
-
-
-
A Coruña, Espanja, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
-
Barcelona, Espanja, 08035
- Hospital Universitari Vall d'Hebron
-
Madrid, Espanja, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Espanja, 28046
- Hospital Universitario La Paz
-
Madrid, Espanja, 28009
- Hospital General Universitario Gregorio Marañón
-
Málaga, Espanja, 29010
- Hospital Regional Universitario Carlos Haya
-
Seville, Espanja, 41013
- Hospital Universitario Virgen del Rocío
-
Seville, Espanja, 41014
- Hospital Univ. Nuestra Señora de Valme
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Espanja, 07198
- Hospital Son Llatzer
-
-
Barcelona
-
Badalona, Barcelona, Espanja, 08916
- Hospital Universitari Germans Trias i Pujol
-
-
Castellon
-
Castellon, Castellon, Espanja, 12002
- Hospital Provincial de Castellon
-
-
-
-
-
Cheongju-si, Etelä -Korea, 28644
- Chungbuk National University Hospital
-
Daegu, Etelä -Korea, 41404
- Kyungpook National University Chilgok Hospital
-
Gyeonggi-do, Etelä -Korea, 13620
- Seoul National University Bundang Hospital
-
Gyeonggi-do, Etelä -Korea, 16247
- St. Vincent's Hospital
-
Gyeonggi-do, Etelä -Korea, 10408
- National Cancer Center
-
Gyeonggi-do, Etelä -Korea, 16499
- Ajou University Medical Center
-
Gyeongsangnam-do, Etelä -Korea, 50612
- Pusan National University Yangsan Hospital
-
Incheon, Etelä -Korea, 21565
- Gachon University Gil Medical Center
-
Jeollanam-do, Etelä -Korea, 58128
- Chonnam National University Hwasun Hospital
-
Seoul, Etelä -Korea, 03080
- Seoul National University Hospital
-
Seoul, Etelä -Korea, 05505
- Asan Medical Center
-
Seoul, Etelä -Korea, 06351
- Samsung Medical Center
-
Seoul, Etelä -Korea, 08308
- Korea University Guro Hospital
-
Seoul, Etelä -Korea, 06591
- Seoul St Mary's Hospital
-
Ulsan, Etelä -Korea, 44033
- Ulsan University Hosiptal
-
-
-
-
-
Hong Kong, Hong Kong
- Tuen Mun Hospital
-
Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
-
Hong Kong, Hong Kong, DUMMY_VALUE
- Queen Elizabeth Hospital
-
Hong Kong, Hong Kong, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
-
Pokfulam, Hong Kong, DUMMY_VALUE
- Queen Mary Hospital
-
-
-
-
-
Beersheba, Israel, 8410100
- Soroka Medical Center
-
Haifa, Israel, 3109601
- Rambam Medical Center
-
Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
-
Petah Tikva, Israel, 4941492
- Rabin Medical Center
-
-
-
-
Campania
-
Naples, Campania, Italia, 80131
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
-
-
Emilia-Romagna
-
Meldola, Emilia-Romagna, Italia, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
-
Parma, Emilia-Romagna, Italia, 43100
- Azienda Ospedaliero Universitaria di Parma
-
-
Lazio
-
Rome, Lazio, Italia, 00128
- Policlinico Universitario Campus Biomedico
-
Rome, Lazio, Italia, 00144
- IRCCS Istituto Regina Elena (IFO)
-
-
Liguria
-
Genoa, Liguria, Italia, 16132
- IRCCS AOU San Martino - IST
-
-
Lombardy
-
Brescia, Lombardy, Italia, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
-
Milan, Lombardy, Italia, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
-
Pavia, Lombardy, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo
-
-
Tuscany
-
Pisa, Tuscany, Italia, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
-
-
Veneto
-
Vicenza, Veneto, Italia, 36100
- Azienda ULSS 8 Berica
-
-
-
-
-
Innsbruck, Itävalta, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
-
Linz, Itävalta, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
-
Vienna, Itävalta, 1140
- Klinik Penzing
-
-
-
-
-
Aichi, Japani, 464-8681
- Aichi Cancer Center
-
Chiba, Japani, 277-8577
- National Cancer Center East
-
Hyōgo, Japani, 670-8520
- National Hospital Organization Himeji Medical Center
-
Kanagawa, Japani, 252-0375
- Kitasato University Hospital
-
Kyoto, Japani, 606-8507
- Kyoto University Hospital
-
Miyagi, Japani, 981-0914
- Sendai Kousei Hospital
-
Niigata, Japani, 951-8566
- Niigata Cancer Center Hospital
-
Osaka, Japani, 589-8511
- Kindai University Hospital
-
Saitama, Japani, 362-0806
- Saitama Cancer Center
-
Shizuoka, Japani, 411-8777
- Shizuoka Cancer Center
-
Tokyo, Japani, 104-0045
- National Cancer Center Hospital
-
Tokyo, Japani, 135-8550
- The Cancer Institute Hospital of JFCR
-
Wakayama, Japani, 641-8510
- Wakayama Medical University Hospital
-
-
-
-
British Columbia
-
Abbotsford British Columbia, British Columbia, Kanada, V2S 0C2
- BC Cancer ? Abbotsford
-
Victoria, British Columbia, Kanada, V8R 6V5
- BC Cancer - Victoria
-
-
Ontario
-
Barrie, Ontario, Kanada, L4M 6M2
- Royal Victoria Regional Health Centre
-
Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health System Brampton Civic Hospital
-
Ottawa, Ontario, Kanada, K1H 8L6
- Ottawa Hospital Research Institute
-
-
-
-
-
Beijing, Kiina, 101149
- Beijing Chest Hospital
-
Beijing, Kiina, 100142
- Beijing Cancer Center
-
Changchun, Kiina, 132013
- Jilin cancer hospital
-
Changsha, Kiina, 410008
- Xiangya Hospital Central South University
-
Chengdu, Kiina, 610041
- Sichuan Provincial Cancer Hospital
-
Chongqing, Kiina, 400030
- Chongqing Cancer Hospital
-
Fujian, Kiina, 350001
- Fujian Medical University Union Hospital
-
Fuzhou, Kiina, 350014
- Fujian Provincial Cancer Hospital
-
Guangzhou, Kiina, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
-
Hangzhou, Kiina, 310002
- Hangzhou Cancer Hospital
-
Jinan, Kiina, 250117
- Shandong Cancer Hospital
-
Nanjing, Kiina, 210009
- Zhongda Hospital Affiliated to Southeast University
-
Qingdao, Kiina, 266042
- The Affiliated Hospital of Qingdao University
-
Shanghai, Kiina, 200000
- Shanghai Chest Hospital
-
Shantou, Kiina, 515041
- Cancer Hospital of Shantou University Medical College
-
Taiyuan, Kiina, 030013
- Shanxi Provincial Cancer Hospital
-
Tianjin, Kiina, 300060
- Tianjin Cancer Hospital
-
Wenzhou, Kiina, 325000
- The 2nd School of Medicine, WMU
-
Xiamen, Kiina, 361003
- The First Affiliated Hospital of Xiamen University
-
Xuzhou, Kiina, 221000
- The Affiliated Hospital of Xuzhou Medical College
-
Zhengzhou, Kiina, 450008
- Henan Cancer Hospital
-
-
-
-
-
Asvestochóri, Kreikka, 570 10
- General Hospital "G.Papanikolaou"
-
Athens, Kreikka, 11527
- Sotiria Hospital
-
Kifissia, Kreikka, 145 64
- Agioi Anargyroi Cancer Hospital
-
-
-
-
-
Coimbra, Portugali, 3000-075
- IPO de Coimbra
-
Lisbon, Portugali, 1500-650
- Hospital da Luz
-
Porto, Portugali, 4100-180
- Hospital CUF Porto
-
Porto, Portugali, 4200-072
- IPO do Porto
-
-
-
-
-
Gda?sk, Puola, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Olsztyn, Puola, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
-
Otwock, Puola, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
-
Warsaw, Puola, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
-
Wroc?aw, Puola, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
-
-
-
Angers, Ranska, 49933
- CHU Angers
-
Caen, Ranska, 14000
- Centre François Baclesse
-
Marseille, Ranska, 13015
- Hopital Nord AP-HM
-
Montpellier, Ranska, 34070
- Clinique Clementville
-
Vantoux, Ranska, 57070
- Hôpital Robert Schuman
-
Villejuif, Ranska, 94805
- Institut Gustave Roussy
-
-
-
-
-
Braunschweig, Saksa, 38114
- Klinikum Braunschweig
-
Cologne, Saksa, 51109
- Klinikum Koeln-Merheim
-
Göttingen, Saksa, 37075
- Universitaetsmedizin Goettingen
-
Heidelberg, Saksa, 69126
- Thoraxklinik Heidelberg gGmbH
-
München, Saksa, 81925
- Klinikum Bogenhausen
-
Regensburg, Saksa, 93053
- Universitätsklinikum Regensburg
-
-
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 112
- Taipei Veterans General Hospital
-
-
-
-
-
Bangkok, Thaimaa, 10400
- Rajavithi Hospital
-
Bangkok, Thaimaa, 10300
- Vajira Hospital
-
Bangkok, Thaimaa, 10400
- Ramathibodi Hospital;Medicine/Oncology
-
Songkhla, Thaimaa, 90110
- Songklanagarind Hospital
-
-
-
-
-
Adana, Turkki (Türkiye), 01220
- Adana Baskent University Medical Faculty
-
Ankara, Turkki (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
-
Ankara, Turkki (Türkiye), 06100
- Ankara University Medical Faculty
-
Ankara, Turkki (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
-
Bornova, ?zm?r, Turkki (Türkiye), 35100
- Ege University Medical Faculty
-
Diyarbakır, Turkki (Türkiye), 21280
- Dicle University Faculty of Medicine
-
Edirne, Turkki (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
-
Istanbul, Turkki (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
-
Istanbul, Turkki (Türkiye), 34214
- Medipol University Medical Faculty
-
Malatya, Turkki (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
-
-
-
-
-
Pécs, Unkari, 7623
- Pecsi Tudomanyegyetem
-
Tatabánya, Unkari, 2800
- Szent Borbala Korhaz
-
Törökbálint, Unkari, 2045
- Tudogyogyintezet Torokbalint
-
-
-
-
-
Auckland, Uusi Seelanti, 1023
- Auckland City Hospital, Cancer and Blood Research
-
-
-
-
-
Birmingham, Yhdistynyt kuningaskunta, B9 5SS
- Birmingham Heartlands Hospital
-
Cambridge, Yhdistynyt kuningaskunta, CB2 0QQ
- Addenbrooke's NHS Trust
-
Glasgow, Yhdistynyt kuningaskunta, G12 0YN
- Beatson West of Scotland Cancer Centre
-
Huddersfield, Yhdistynyt kuningaskunta, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
-
Leicester, Yhdistynyt kuningaskunta, LE1 5WW
- Leicester Royal Infirmary
-
Maidstone, Yhdistynyt kuningaskunta, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
-
Manchester, Yhdistynyt kuningaskunta, M20 4BX
- Christie Foundation Trust
-
Sheffield, Yhdistynyt kuningaskunta, S10 2SJ
- Weston Park Hospital
-
-
-
-
California
-
Palo Alto, California, Yhdysvallat, 94305
- Stanford University
-
-
Colorado
-
Greeley, Colorado, Yhdysvallat, 80631
- Banner MD Anderson Cancer Center
-
-
Florida
-
Fort Myers, Florida, Yhdysvallat, 33901-8101
- Florida Cancer Specialists
-
Palm Bay, Florida, Yhdysvallat, 32901
- Cancer Care Centers of Brevard
-
Pensacola, Florida, Yhdysvallat, 32503
- Woodlands Medical Specialists, P.A.
-
St. Petersburg, Florida, Yhdysvallat, 33705
- Florida Cancer Specialist, North Region
-
-
Georgia
-
Marietta, Georgia, Yhdysvallat, 30060
- Northwest Georgia Oncology Centers PC - Marietta
-
-
Illinois
-
Peoria, Illinois, Yhdysvallat, 61615
- Illinois Cancer Care
-
-
Maine
-
Brunswick, Maine, Yhdysvallat, 04011
- New England Cancer Specialists
-
-
Massachusetts
-
Fairhaven, Massachusetts, Yhdysvallat, 02719
- Southcoast Health System
-
-
Minnesota
-
Minneapolis, Minnesota, Yhdysvallat, 55404
- Minnesota Oncology Hematology
-
-
Missouri
-
Kansas City, Missouri, Yhdysvallat, 64132
- HCA Midwest Health
-
Springfield, Missouri, Yhdysvallat, 65807
- Cox Health Systems
-
-
Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89106
- Optum Health Care
-
-
New Jersey
-
East Brunswick, New Jersey, Yhdysvallat, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
-
-
New Mexico
-
Farmington, New Mexico, Yhdysvallat, 87401
- San Juan Oncology Associates
-
-
New York
-
Albany, New York, Yhdysvallat, 12208
- New York Oncology Hematology,P.C.-Albany
-
New York, New York, Yhdysvallat, 10029
- Mount Sinai Medical Center
-
The Bronx, New York, Yhdysvallat, 10461
- Montefiore Medical Center
-
-
South Carolina
-
Greenville, South Carolina, Yhdysvallat, 29615
- Prisma Health ? Upstate
-
-
Tennessee
-
Chattanooga, Tennessee, Yhdysvallat, 37403
- Tennessee Oncology Chattanooga
-
Nashville, Tennessee, Yhdysvallat, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
-
-
Virginia
-
Fairfax, Virginia, Yhdysvallat, 22031
- Virginia Cancer Specialists
-
Norfolk, Virginia, Yhdysvallat, 23502
- Virginia Oncology Associates
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- Eastern Cooperative Oncology Groupin (ECOG) suorituskyvyn tila 0 tai 1
- Histologisesti tai sytologisesti dokumentoitu NSCLC, jossa on paikallisesti pitkälle edennyt, leikkaukseen kelpaamaton vaiheen III NSCLC, joka on joko levyepiteelistä tai ei-squamous histologiaa
- Koko kehon positroniemissiotomografia-tietokonetomografia (PET-CT), tehty ennen ensimmäistä samanaikaista kemoradioterapiaa (cCRT) ja 42 päivän sisällä sen jälkeen
- Vähintään kaksi aikaisempaa platinapohjaista kemoterapiasykliä, jotka on annettu samanaikaisesti sädehoidon (RT) kanssa, jotka on saatava päätökseen 1–42 päivän kuluessa ennen satunnaistamista tutkimuksessa (yksi cCRT-sykli määritellään 21 tai 28 päiväksi)
- cCRT:n sädehoitokomponentin (RT) kokonaissäteilyannoksen on täytynyt olla 60 (±10 prosenttia [%)) harmaata (Gy) (54 Gy - 66 Gy) intensiteettimoduloidulla RT:llä (suositeltava) tai 3D- mukautuvaa tekniikkaa
- Ei etenemistä samanaikaisen platinapohjaisen CRT:n aikana tai sen jälkeen
- Tunnettu PD-L1 tulos
- Elinajanodote >/= 12 viikkoa
- Riittävä hematologinen ja pääteelinten toiminta
- Naispuolisten osallistujien on oltava valmiita välttämään raskautta 90 päivän ajan viimeisen tiragolumabiannoksen jälkeen ja 5 kuukauden ajan viimeisen atetsolitsumabiannoksen jälkeen tai 3 kuukauden ajan viimeisen durvalumabiannoksen jälkeen.
- Miesosallistujien on pysyttävä pidättyväisinä tai käytettävä kondomia hoidon aikana ja 90 päivän ajan viimeisen tiragolumabiannoksen jälkeen
- Miesosallistujat eivät saa luovuttaa siittiöitä hoitojakson aikana ja 90 päivään viimeisen tiragolumabiannoksen jälkeen
Poissulkemiskriteerit:
- Mikä tahansa aikaisempi NSCLC ja/tai aiempi NSCLC-hoito (osallistujilla on äskettäin diagnosoitu ei-leikkausvaiheen III sairaus)
- NSCLC:llä tiedetään olevan mutaatio epidermaalisen kasvutekijäreseptorin (EGFR) geenissä tai anaplastisen lymfoomakinaasin (ALK) fuusioonkogeenissä
- Kaikki todisteet vaiheen IV taudista
- Hoito peräkkäisellä CRT:llä paikallisesti edenneen NSCLC:n hoidossa
- Osallistujat, joilla on paikallisesti edennyt NSCLC ja jotka ovat edenneet lopullisen cCRT:n aikana tai sen jälkeen ennen satunnaistamista
- Mikä tahansa asteen > 2 ratkaisematon toksisuus edellisestä CRT:stä
- Asteen >= 2 pneumoniitti aikaisemmasta CRT:stä
- Aktiivinen tai aiempi autoimmuunisairaus tai immuunipuutos
- Aiempi idiopaattinen keuhkofibroosi, organisoiva keuhkokuume, lääkkeiden aiheuttama keuhkotulehdus tai idiopaattinen keuhkotulehdus tai näyttöä aktiivisesta keuhkotulehduksesta
- Anamneesissa muu pahanlaatuinen kasvain kuin NSCLC 5 vuoden aikana ennen seulontaa, lukuun ottamatta pahanlaatuisia kasvaimia, joiden etäpesäkkeiden tai kuoleman riski on vähäinen
- Aiempi allogeeninen kantasolu- tai kiinteä elinsiirto
- Aktiivinen Epstein-Barr-virus (EBV) -infektio tai tunnettu tai epäilty krooninen aktiivinen EBV-infektio seulonnassa
- Hoito tutkimushoidolla 28 päivän sisällä ennen tutkimushoidon aloittamista
- Aiempi hoito CD137-agonisteilla tai immuunitarkistuspisteen salpaushoidot, mukaan lukien anti-sytotoksinen T-lymfosyyteihin liittyvä proteiini 4, anti-T-soluimmunoreseptori, jossa on Ig- ja ITIM-domeeneja (anti-TIGIT), anti-PD-1 ja anti-PD-L1
- Mikä tahansa aikaisempi asteen >/= 3 immuunivälitteinen haittatapahtuma tai mikä tahansa ratkaisematon asteen > 1 immuunivälitteinen haittatapahtuma saattaessa mitä tahansa muuta immunoterapia-ainetta kuin immuunitarkastuspisteen salpaajia
- Hoito systeemisillä immunosuppressiivisilla lääkkeillä
- Naiset, jotka ovat raskaana tai imettävät
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Atetsolitsumabi + Tiragolumabi
Osallistujat saavat atetsolitsumabia suonensisäisenä (IV) jokaisena 28 päivän syklin päivänä 1, minkä jälkeen tiragolumabia IV kunkin 28 päivän syklin päivänä 1 enintään 13 syklin ajan.
|
Atetsolitsumabia 1680 mg joka 4. viikko (Q4W) annetaan laskimonsisäisesti jokaisen 28 päivän syklin ensimmäisenä päivänä.
Muut nimet:
Tiragolumabi 840 mg Q4W annetaan laskimonsisäisesti jokaisen 28 päivän syklin ensimmäisenä päivänä.
Muut nimet:
|
|
Active Comparator: Durvalumabi
Osallistujat saavat durvalumabia suonensisäisenä jokaisen 28 päivän syklin aikana enintään 13 syklin ajan.
|
Durvalumabia annetaan painon perusteella annoksella 10 mg/kg IV joka 2. viikko (Q2W) jokaisen 28 päivän syklin päivinä 1 ja 15, tai se annetaan kiinteänä annoksena 1500 mg IV joka 4. viikko (Q4W) ( osallistujille, joiden paino on >/= 30 kg) jokaisen 28 päivän syklin ensimmäisenä päivänä.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Aikaikkuna: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions.
Kaplan-Meier (K-M) method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
PFS, as Assessed by an IRF in FAS
Aikaikkuna: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Survival (OS) in PPAS
Aikaikkuna: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in PPAS
Aikaikkuna: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
Aikaikkuna: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in PPAS
Aikaikkuna: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Duration of Response (DOR), as Assessed by an IRF in PPAS
Aikaikkuna: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in PPAS
Aikaikkuna: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better health-related quality-of-life (HRQoL).
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
OS in FAS
Aikaikkuna: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in FAS
Aikaikkuna: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed ORR, as Assessed by an IRF in FAS
Aikaikkuna: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in FAS
Aikaikkuna: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
DOR, as Assessed by an IRF in FAS
Aikaikkuna: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in FAS
Aikaikkuna: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better HRQoL.
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
Aikaikkuna: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
Aikaikkuna: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
Aikaikkuna: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in PPAS
Aikaikkuna: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
Aikaikkuna: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
Aikaikkuna: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS
Aikaikkuna: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in FAS
Aikaikkuna: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
TTDM, as Assessed by the Investigator in FAS
Aikaikkuna: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
Number of Participants With Adverse Events (AEs)
Aikaikkuna: Up to approximately 24.7 months
|
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
|
Up to approximately 24.7 months
|
|
Number of Participants With Cytokine Release Syndrome (CRS)
Aikaikkuna: Up to approximately 24.7 months
|
CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells.
Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction.
|
Up to approximately 24.7 months
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Clinical Trials, Hoffmann-La Roche
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 24. elokuuta 2020
Ensisijainen valmistuminen (Todellinen)
Tiistai 27. toukokuuta 2025
Opintojen valmistuminen (Todellinen)
Torstai 31. heinäkuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 13. elokuuta 2020
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 13. elokuuta 2020
Ensimmäinen Lähetetty (Todellinen)
Perjantai 14. elokuuta 2020
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 3. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 7. toukokuuta 2026
Viimeksi vahvistettu
Perjantai 1. toukokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Hengityselinten sairaudet
- Keuhkosairaudet
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Keuhkojen kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Karsinooma, ei-pienisoluinen keuhko
- Antineoplastiset aineet, immunologiset
- Immuunijärjestelmän tarkistuspisteen estäjät
- Antineoplastiset aineet
- Farmakologisen vaikutuksen molekyylimekanismit
- durvalumabi
- söpö
- Tiragolumabi
Muut tutkimustunnusnumerot
- GO41854
- 2019-004773-29 (EudraCT-numero)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Pätevät tutkijat voivat pyytää pääsyä yksittäisen potilastason tietoihin kliinisen tutkimuksen tietojen pyyntöalustan (www.vivli.org) kautta.
Lisätietoja Rochen tukikelpoisten opintojen kriteereistä on saatavilla täältä (https://vivli.org/members/ourmembers/). Lisätietoja Rochen kliinisten tietojen jakamista koskevasta maailmanlaajuisesta käytännöstä ja siihen liittyvien kliinisten tutkimusten asiakirjojen pyytämisestä on täällä (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .