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Active (not recruiting) Phase 3 NCT04303780

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Phase 3 – large-scale trial before approval
Conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Sponsor: Amgen

trial.available_in: БГ
Overview
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Who can participate
Inclusion Criteria: * Men or women greater than or equal to 18 years old. * ECOG ≤ 1 * Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment Exclusion Criteria: * Active brain metastases * Myocardial infarction within 6 months of study day 1 * Gastrointestinal (GI) tract disease causing the inability to take oral medication
Locations 20
Australia (1)
Blacktown Hospital
Blacktown , New South Wales
Belgium (1)
Institute Jules Bordet
Brussels
Brazil (1)
Hospital de Caridade de Ijui
Ijuí , Rio Grande do Sul
Canada (1)
Tom Baker Cancer Centre
Calgary , Alberta
Denmark (1)
Herlev og Gentofte Hospital
Herlev
Finland (1)
Docrates Syopasairaala
Helsinki
France (1)
Centre Hospitalier Regional Universitaire - Hopital Morvan
Brest
Greece (1)
Agios Savvas Anticancer Hospital
Athens
Hungary (1)
Semmelweis Egyetem
Budapest
Italy (1)
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati
Avellino
Japan (1)
Aichi Cancer Center Hospital
Nagoya , Aichi-ken
Netherlands (1)
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Russia (1)
Clinical hospital 2, Group of companies medsi
Moscow
South Korea (1)
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do
Spain (1)
Hospital Regional Universitario de Malaga
Málaga , AndalucÃ-a
Sweden (1)
Gavle Sjukhus
Gävle
Taiwan (1)
China Medical University Hospital
Taichung
United Kingdom (1)
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge
United States (1)
Pacific Cancer Medical Center Inc
Anaheim , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
04.06.2020
Completion date
29.05.2026
Registry ID
NCT04303780
Source
anzctr
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