En studie av V940/Placebo + Pembrolizumab og kjemoterapi ved metastatisk skivepitelkreft i lungecancer (V940-013) (INTerpath-13)
En fase 2, randomisert, dobbeltblind, placebokontrollert studie av V940 i kombinasjon med pembrolizumab og kjemoterapi som første-linje behandling for deltakere med metastatisk skivepitelcelle NSCLC (INTerpath-013)
Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer.
The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Rekruttering
- Instituto Alexander Fleming ( Site 0201)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +541132218956
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Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina, C1199ABB
- Rekruttering
- Hospital Italiano de Buenos Aires ( Site 0200)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +541149590497
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Rekruttering
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5492235937663
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Buenos Aires F.D.
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Caba., Buenos Aires F.D., Argentina, C1430EGF
- Rekruttering
- Clinica Adventista Belgrano ( Site 0206)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5491140141500
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Rekruttering
- Fundacion Estudios Clinicos ( Site 0207)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5493413168137
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Rekruttering
- Sanatorio Parque ( Site 0203)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +543874044942
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Rekruttering
- Westmead Hospital ( Site 0400)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +61298455555
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Rekruttering
- Princess Alexandra Hospital ( Site 0403)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +61731762111
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Rekruttering
- One Clinical Research ( Site 0402)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6186279 9466
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Antofagasta, Chile, 1263521
- Rekruttering
- Bradford Hill Norte ( Site 0308)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56442023631
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500653
- Rekruttering
- Centro de Estudios Clínicos SAGA ( Site 0307)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56991612199
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Santiago, Region M. de Santiago, Chile, 8420383
- Rekruttering
- Bradfordhill ( Site 0301)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56 2 29490970
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Santiago, Region M. de Santiago, Chile, 7500921
- Rekruttering
- Fundación Arturo López Pérez ( Site 0300)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56224205098
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Florida
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffitt Cancer Center ( Site 0021)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 813-745-7363
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Michigan
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Ann Arbor, Michigan, Forente stater, 48105
- Rekruttering
- VA Ann Arbor Healthcare System ( Site 0019)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 734-769-7100
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University School of Medicine ( Site 0024)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 314-362-5000
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New Jersey
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Paramus, New Jersey, Forente stater, 07652
- Rekruttering
- Valley Health Systems - Ridgewood Campus ( Site 0010)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 201-634-5578
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New York
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Albany, New York, Forente stater, 12206
- Rekruttering
- New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 518-489-0044
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic - Ohio ( Site 0016)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-445-7855
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Oregon
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Corvallis, Oregon, Forente stater, 97330
- Rekruttering
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 541-768-4950
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 615-961-9469
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Texas
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Austin, Texas, Forente stater, 78745
- Rekruttering
- Texas Oncology - Central/South Texas ( Site 8002)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 512-427-9400
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists ( Site 0003)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 730-280-5390
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- Swedish Medical Center-Swedish Cancer Institute ( Site 0023)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 855-922-6237
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Cote-d Or
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Dijon, Cote-d Or, Frankrike, 21000
- Rekruttering
- Centre Georges François Leclerc ( Site 0805)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33345348051
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Pays de la Loire Region
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Angers, Pays de la Loire Region, Frankrike, 49055
- Rekruttering
- Institut de Cancérologie de l'Ouest ( Site 0801)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33 (0)2.44 85 35 54
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Puy-de-Dome
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Clermont-Ferrand, Puy-de-Dome, Frankrike, 63001
- Rekruttering
- CHU GABRIEL MONTPIED ( Site 0802)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33473754440
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Milan, Italia, 20132
- Rekruttering
- Ospedale San Raffaele-Oncologia Medica ( Site 1002)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390226436633
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Milan, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390223903829
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Perugia, Italia, 06132
- Rekruttering
- AO Santa Maria della Misericordia-Oncology Department ( Site 1005)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390755782661
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00390630154277
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Emilia-Romagna
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Ravenna, Emilia-Romagna, Italia, 48121
- Rekruttering
- Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390544285247
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-569
- Rekruttering
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48616654242
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48225463066
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Podkarpackie Voivodeship
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Przemyśl, Podkarpackie Voivodeship, Polen, 37-700
- Rekruttering
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48166775000
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Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d''Hebron ( Site 1310)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 93 254 3450
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Madrid, Spania, 28034
- Rekruttering
- Hospital Ramon y Cajal ( Site 1314)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 91 336 82 63
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Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos... ( Site 1313)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 913303000
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Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 671560092
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Barcelona
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Hospitalet, Barcelona, Spania, 08907
- Rekruttering
- ICO L Hospitalet ( Site 1311)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 93 260 77 44
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Cadiz
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Jerez de la Frontera, Cadiz, Spania, 11407
- Rekruttering
- Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 956 03 22 44
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center ( Site 0503)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82230103215
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center ( Site 0502)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82234101132
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Kyonggi-do
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Goyang-si, Kyonggi-do, Sør -Korea, 10408
- Rekruttering
- National Cancer Center ( Site 0504)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82319200114
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Seongnam-si, Kyonggi-do, Sør -Korea, 13620
- Rekruttering
- Seoul National University Bundang Hospital ( Site 0500)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82317877071
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North Chungcheong
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Cheongju-si, North Chungcheong, Sør -Korea, 28644
- Rekruttering
- Chungbuk National University Hospital-Internal medicine ( Site 0501)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 043-269-6015
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Taichung, Taiwan, 404
- Rekruttering
- China Medical University Hospital ( Site 0606)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886422052121
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Tainan, Taiwan, 70403
- Rekruttering
- National Cheng Kung University Hospital ( Site 0601)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88662353535
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Taipei, Taiwan, 104
- Rekruttering
- Mackay Memorial Hospital ( Site 0604)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886225433535
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Taipei, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital ( Site 0602)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88628712121
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Taipei, Taiwan, 106
- Rekruttering
- National Taiwan University Cancer Center (NTUCC) ( Site 0600)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886223220322
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Taoyuan, Taiwan, 33305
- Rekruttering
- Chang Gung Medical Foundation-Linkou Branch ( Site 0605)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88633281200
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Ankara, Tyrkia (Türkiye), 06230
- Rekruttering
- Hacettepe Universitesi Tıp Fakultesi ( Site 1400)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +905436067759
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Ankara, Tyrkia (Türkiye), 06800
- Rekruttering
- Ankara Bilkent Şehir Hastanesi ( Site 1402)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +905384724282
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Ankara, Tyrkia (Türkiye), 06520
- Rekruttering
- Memorial Ankara Hastanesi ( Site 1401)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +9005321332009
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Istanbul, Tyrkia (Türkiye), 34010
- Rekruttering
- Koç Üniversitesi Hastanesi ( Site 1403)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +905369410661
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
- Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
- Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
- Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
- Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has a life expectancy of at least 3 months
- Has adequate organ function
Exclusion Criteria:
Exclusion Criteria include, but are not limited to:
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
- Has received prior systemic anticancer therapy for their metastatic NSCLC
- Has received prior therapy with an anti-programmed cell death 1 protein (anti-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 coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
- 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 an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intismeran Autogene + Pembrolizumab + Chemo
Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Intismeran Autogene 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance. |
1 mg Intramuscular (IM) Injection
Andre navn:
200 mg IV Infusion
Andre navn:
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion 200 or 175 mg/m^2 IV Infusion 100 mg/m^2 IV Infusion |
|
Eksperimentell: Placebo + Pembrolizumab + Chemo
Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance. |
200 mg IV Infusion
Andre navn:
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion 200 or 175 mg/m^2 IV Infusion 100 mg/m^2 IV Infusion Placebo matched to Intismeran Autogene IM injection |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: Up to ~32 months
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. |
Up to ~32 months
|
|
Overall Survival (OS)
Tidsramme: Up to ~42 months
|
OS, defined as the time from randomization to death due to any cause. OS will be presented. |
Up to ~42 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Response Rate (ORR)
Tidsramme: Up to ~26 months
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
Up to ~26 months
|
|
Duration of Response (DOR)
Tidsramme: Up to ~42 months
|
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to ~42 months
|
|
Number of Participants who Experience an Adverse Event (AE)
Tidsramme: Up to ~42 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. |
Up to ~42 months
|
|
Number of Participants who Discontinue Study Intervention Due to an AE
Tidsramme: Up to ~24 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be presented. |
Up to ~24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- V940-013
- V940-013 (Annen identifikator: MSD)
- U1111-1318-2495 (Registeridentifikator: UTN)
- 2025-520902-37-00 (Registeridentifikator: EU CT)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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