A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
Inclusion Criteria:
Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
Participant has no contraindications to mFOLFOX6 chemotherapy
Adequate organ and bone marrow function:
Exclusion Criteria:
Brooklyn, New York 11220, United States
CABA, Buenos Aires C1426ANZ, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1093AAS, Argentina
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Florianópolis, Santa Catarina 88020-210, Brazil
Branipole Village, 4109, Bulgaria
Sofia, 1407, Bulgaria
Wuhan, Hebei 430030, China
Luoyang, Henan 471000, China
Wuhan, Hubei 430000, China
Shanghai, Shanghai Municipality 201800, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Rionegro, Antioquia 054040, Colombia
Clermont-Ferrand, 63003, France
Saint-Priest-en-Jarez, 42270, France
Heraklion - Crete, 71500, Greece
Nyíregyháza, 4400, Hungary
Catania, 95122, Italy
Lecce, 73100, Italy
Monserrato CA, 09042, Italy
Rozzano MI, 20089, Italy
Udine, 33100, Italy
Verona, 37126, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Akashi-shi, Hyōgo 673-8558, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Hirakata-shi, Osaka 573-1191, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Suita-shi, Osaka 565-0871, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Koto-ku, Tokyo 135-8550, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Kaunas, 50161, Lithuania
Radom, 26-600, Poland
Santa Maria da Feira, 4520-211, Portugal
Gauteng, 2021, South Africa
Goyang-si Gyeonggi-do, 10408, South Korea
Seongnam-si, Gyeonggi-do, 13620, South Korea
Adana, 01250, Turkey (Türkiye)
Ankara, 06100, Turkey (Türkiye)