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Identifier: NCT03504397. Park: Full/Part-time employment: Astellas Pharma. CancerLinQ A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer - NCT03504397 Zolbetuximab (zolbe), a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Enter words / phrases / DOI / ISBN / authors / keywords / etc. ASCO Daily News Patients will receive zolbe 800 mg/m2 IV on Cycle 1 Day 1 (loading dose), then 600 mg/m2 IV every 3 weeks; mFOLFOX6 will be administered on Days 1, 15, and 29 of each 42-day cycle (4 cycles). Randomization will be stratified by region (Asia vs non-Asia), number of metastatic sites (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). The website cannot function properly without these cookies, and can only be disabled by changing your browser preferences. Subscribers P.C. Contact Us Phase of Trial Phase 3 Trial summary A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. In healthy tissue, CLDN18.2, a tight junction protein, is confined to gastric mucosa (ie, cells in the pit and base regions of gastric glands). A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. This global, phase III, double-blind, placebo-controlled study (NCT03653507) will enroll ∼500 adult pts with CLDN18.2+/HER2– locally advanced unresectable or metastatic GC or GEJ not previously treated with chemotherapy for advanced/metastatic disease. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. This study was funded by Astellas Pharma, Inc. K. Shitara: Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Ono Pharmaceutical; Research grant/Funding (institution): Dainippon Sumitomo Pharma; Advisory/Consultancy, Research grant/Funding (institution): MSD; Research grant/Funding (institution): Daiichi Sankyo; Advisory/Consultancy, Research grant/Funding (institution): Taiho Pharmaceutical; Research grant/Funding (institution): Chugai Pharm; Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma; Research grant/Funding (institution): Medi Science; Honoraria (institution), Advisory/Consultancy: Novartis; Honoraria (institution), Advisory/Consultancy: AbbVie; Honoraria (institution): Yakult; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Takeda; Advisory/Consultancy: Pfizer; Advisory/Consultancy: GlaxoSmithKline. Norikazu Masuda, Session: Enzinger: Advisory/Consultancy: Merck; Advisory/Consultancy: Astellas; Advisory/Consultancy: Celgene; Advisory/Consultancy: Lilly; Advisory/Consultancy: Loxo; Advisory/Consultancy: Taiho; Advisory/Consultancy: Zymeworks. Rui-Hua Xu, Presenter: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared with Placebo Plus CAPOX as First-line Treatment of Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Results of a phase 2 study (NCT01630083) showed prolonged survival of patients with CLDN18.2-positive (CLDN18.2+) advanced G/GEJ adenocarcinoma treated with zolbetuximab + epirubicin, oxaliplatin, and capecitabine (EOX) vs EOX alone. Why is this study being done? E. van Cutsem: Advisory/Consultancy: Astellas; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy: Incyte; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme; Advisory/Consultancy, Research grant/Funding (institution): Merck KGaA; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): Servier; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Ipsen. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study Ann Oncol. Phase II (NCT01630083) results showed prolonged survival of patients (pts) with CLDN18.2+ advanced G/GEJ treated with zolbe + epirubicin, oxaliplatin, and capecitabine (EOX) vs EOX alone. 15_suppl, Newest Articles The primary objective is to compare progression-free survival between treatment arms. Between 3 September 2010, and 24 September 2012, 268 patients were screened. Conquer Cancer Foundation Zolbetuximab will be administered at a loading dose of 800 mg/m 2 IV on Cycle 1 Day 1 followed by 600 mg/m 2 IV every 3 weeks. Secondary endpoints are overall survival; objective response rate; duration of response; and the safety/tolerability, pharmacokinetics, and immunogenicity of zolbetuximab. Eligible pts should have locally advanced unresectable or metastatic G/GEJ that is CLDN18.2+/human epidermal growth factor receptor 2-negative (HER2–) and radiologically evaluable lesions per RECIST v1.1. Of the trials investigating zolbetuximab, 2 are phase 2 (2 open) and 2 are phase 3 (2 open). Phase III. DOI: 10.1200/JCO.2020.38.15_suppl.TPS4648 Journal of Clinical Oncology A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight) Sponsor: Astellas Pharma Global Development, Inc. Central testing of tumor tissue will determine CLDN18.2 and HER2 status (if unknown); patients will be considered CLDN18.2+ if ≥75% of tumor cells demonstrate moderate-to-strong membranous immunohistochemical staining. Patients will be randomized 1:1 to receive zolbetuximab + CAPOX or placebo + CAPOX. Upon malignant transformation, structural loss in G/GEJ cells may allow antibodies more access to previously unavailable CLDN18.2. Receive our scientific and educational products, events, membership and educational initiatives. *2 Pennathur A, et al., 2013; Sahin et al., 2008 *3 Ilic M, et al., 2016. Via Ginevra 4, 6900 Lugano - CH© Copyright 2021 European Society for Medical Oncology All rights reserved worldwide. Cookies. A total of 26 patients (cohort 1, n = 1; cohorts 2 and 3, n = 25) discontinued treatment before completing five infusions. STORM was a multicenter, open-label, single arm trial evaluating selinexor … Multiple cancers. Editorial Roster Close published online before print Domenica Lorusso. Key secondary endpoint: overall survival. Claudin (CLDN)18.2, a tight junction protein and new molecular target, is confined to gastric mucosa (ie, cells in the pit and base regions of the gastric glands) in healthy tissue. Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. MINIMAL Requirements: Google Chrome 24+, Mozilla Firefox 20+, Internet Explorer 11, Opera 15–18, Apple Safari 7, SeaMonkey 2.15-2.23. JCO Oncology Practice *3 *1 World Health Organization Cancer Fact Sheet 2018. Tumor t… Annals of Oncology (2020) 31 (suppl_6): S1287-S1318. A Phase 3, Double-Blind, Randomized, Efficacy Study of Zolbetuximab Plus CAPOX Compared with Placebo Plus CAPOX of Subjects with Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma DOI: 10.1200/JCO.2020.38.15_suppl.TPS4648 Journal of Clinical Oncology - Prior chemotherapy for advanced/metastatic G/GEJ is not permitted. Zolbetuximab is currently under development also in pancreatic adenocarcinoma. To sign up for ESMO newsletters, simply create a myESMO account here and select the newsletters you’d like to receive. ClinicalTrials.gov. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma. Reviewers Details J.W. Of these, 54 patients were eligible and four received 300 mg/m 2 zolbetuximab in cohort 1, and 50 received 600 mg/m 2 zolbetuximab in cohorts 2 and 3. Overall, the development of targeted treatments for GC has failed, except for that of HER2- and VEGFR2-targeted drugs. Patients will be randomly assigned 1:1 to receive either zolbetuximab plus CAPOX or placebo plus CAPOX. Presenter: D.H. Ilson: Advisory/Consultancy: Astellas Pharma. Methods: This phase 3, double-blind, ... (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). ASP1948/PTZ-329 Anti-NRP1 antibody. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Eligibility ASCO Author Services ASCO Meetings Bang: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): Merck Serano; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution): Taiho; Advisory/Consultancy, Research grant/Funding (institution): Daiichi Sankyo; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): BeiGene; Advisory/Consultancy, Research grant/Funding (institution): GreenCross; Advisory/Consultancy: Samyang Biopharm; Advisory/Consultancy: Hanmi; Advisory/Consultancy, Research grant/Funding (institution): Genexine; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Boeringer Ingelheim; Research grant/Funding (institution): MacroGenics. Zolbetuximab 800/600 mg/m 2 is being evaluated in phase III studies based on clinical benefit observed in the overall population and in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells. The ASCO Post A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Shukui Qin, Presenter: e-Poster Display Session, Presenter: SPOTLIGHT (NCT03504397) is enrolling ∼550 pts from global sites including China, Japan, Korea, and Taiwan. A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. R-H. Xu: Honoraria (institution): Merck; Honoraria (institution): Roche. Hiroki Yukami, Presenter: Permissions, Authors Pancreatic cancer is the seventh leading cause of cancer death worldwide, *1 and shows low overall five-year survival rate as 4%. Gastric and gastroesophageal junction adenocarcinoma. JCO Global Oncology TAPUR Study, Terms of Use | Privacy Policy | Clinical trial information: NCT03653507. ESMO is a Swiss-registered not-for-profit organisation. JCO Clinical Cancer Informatics Upon malignant transformation, structural loss in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma cells may allow antibodies more access to previously unavailable CLDN18.2. JCO OP DAiS, ASCO eLearning Patients are not permitted to have received prior treatment with chemotherapy for advanced or metastatic G or GEJ adenocarcinoma. A. Arozullah: Full/Part-time employment: Astellas Pharma. Weill Cornell Medical College, New York, NY; The University of Texas - MD Anderson Cancer Center, Houston, TX; Institut für Klinisch-Onkologische Forschung, Frankfurt, Germany; Seoul National University College of Medicine, Seoul, South Korea; Gastrointestinal Oncology Program, The University of Chicago, Chicago, IL; Dana-Farber Cancer Institute, Boston, MA; Memorial Sloan Kettering Cancer Center, New York, NY; University of Colorado Comprehensive Cancer Center, Aurora, CO; University Cancer Center Leipzig, Leipzig, Germany; National Cancer Center Hospital East, Kashiwa, Japan; University Hospitals Gasthuisberg Leuven, KU Leuven, Leuven, Belgium; Astellas Pharma Global Development, Inc., Northbrook, IL; Sun Yat-sen University Cancer Centre, Guangzhou, China, Professional English and Academic Editing Support, https://doi.org/10.1200/JCO.2020.38.15_suppl.TPS4648, Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline, Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update, Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE), Prognostic Index for Acute- and Lymphoma-Type Adult T-Cell Leukemia/Lymphoma, Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer, Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update, Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline, Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received, American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options, Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial, 2318 Mill Road, Suite 800, Alexandria, VA 22314, © 2021 American Society of Clinical Oncology. A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Background: Gastric cancer is the fourth leading cause of cancer death worldwide. All other authors have declared no conflicts of interest. Currently, two phase III trials are ongoing to test the 1L use of zolbetuximab in combination with mFOLFOX6 (SPOTLIGHT: NCT03504397) or CAPOX (GLOW: NCT03653507). Primary endpoint: progression-free survival per independent review committee. Other secondary endpoints: objective response rate; duration of response; safety/tolerability, pharmacokinetics, and immunogenicity of zolbe. Pancreatic adenocarcinoma. Necessary cookies enable core functionality. Patients are required to have CLDN18.2+/HER2− locally advanced unresectable or metastatic G or GEJ adenocarcinoma that is radiographically evaluable per RECIST v1.1. Details Meeting Abstracts, About D. Catenacci: Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Merck; Advisory/Consultancy: BMS; Advisory/Consultancy: Lilly; Advisory/Consultancy: Gritstone; Advisory/Consultancy: Taiho; Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Daichii Sankyo. Study design and conduct. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199. SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic … Y-J. J.A. This site uses cookies. Zolbetuximab is a chimeric IgG1 monoclonal antibody that specifically binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Zolbetuximab + EOX was generally tolerated and AEs were manageable. Daniel Petrylak, Presenter: Institutions Full Title A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Positive, HER2- Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (WIRB) Purpose The chemotherapy … Central tumor tissue testing will determine CLDN18.2/HER2 status (if unknown); pts are considered CLDN18.2+ if ≥75% of tumor cells show moderate-to-strong immunohistochemical staining. This multicenter, first-in-human, phase I, single dose–escalation study was conducted at six centres in Germany and Latvia from July 2009 to May 2010. Brief Title: A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer Official Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo … Patients were randomized to ZOL/EOX or EOX alone. Capecitabine + oxaliplatin (CAPOX) is a standard first-line treatment for advanced gastric cancer. Fluorouracil, folinic acid, and oxaliplatin (mFOLFOX6) is accepted first-line therapy for advanced/metastatic G/GEJ. Phase 2 (NCT01630083) results showed prolonged survival with zolbetuximab + epirubicin, oxaliplatin, and capecitabine (EOX) vs EOX alone in G/GEJ. 2.2. Zolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. For more detailed information on the cookies we use, please check our Privacy Policy. ASCO Connection As of January 31, 2020, 127 sites were active and open to enrollment. Methods: This phase 3, double-blind, placebo-controlled study (NCT03653507) will enroll ~500 adult patients from global sites. Zolbetuximab will be administered by IV infusion as an 800 mg/m2 loading dose (Cycle 1, Day 1) followed by 600 mg/m2 Q3W in combination with CAPOX. Metastatic urothelial cancer, previously untreated (first line) ... Zolbetuximab IMAB362 Anti-Claudin 18.2 monoclonal antibody. Archive All funding for this site is provided directly by ESMO. Cancer.Net, ASCO.org Claudin (CLDN)18.2 has emerged as a promising targetable biomarker. Shigehira Saji, Presenter: Advertisers, Journal of Clinical Oncology Phase III. Ajani: Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma. Patients will be randomized 1:1 to zolbe + mFOLFOX6 or placebo + mFOLFOX6. Zolbetuximab will be administered at a loading dose of 800 mg/m2 IV on Cycle 1 Day 1 followed by 600 mg/m2 IV every 3 weeks. ASCO Career Center A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2 Positive, HER2-Negative, Metastatic … A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma 38, no. Patients with ongoing anticancer therapies, an allergy to mAbs, or those who had had <3 weeks since a prior antitumour treatment were excluded. JCO Precision Oncology, ASCO Educational Book 10.1016/annonc/annonc356, SPOTLIGHT: Phase III study of zolbetuximab + mFOLFOX6 versus placebo + mFOLFOX6 in first-line Claudin18.2⁺/HER2⁻ advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ), HER2CLIMB-02: A randomized, double-blind, phase III study of tucatinib or placebo with T-DM1 for unresectable locally-advanced or metastatic HER2+ breast cancer, KEYLYNK-009: A phase II/III, open-label, randomized study of pembrolizumab (pembro) + olaparib (ola) vs pembro + chemotherapy after induction with first-line (1L) pembro + chemo in patients (pts) with locally recurrent inoperable or metastatic TNBC, MADELINE Asia: A mobile app-based prospective observational study of patient reported outcomes in advanced breast cancer in Asia, Prospective observational study monitoring circulating tumour DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan, GLOW: Phase III study of first-line zolbetuximab + CAPOX versus placebo + CAPOX in Claudin18.2⁺/HER2⁻ advanced/metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ), Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, A randomized, double-blind, phase III study of pembrolizumab plus chemotherapy as first-line therapy in patients with HER2-negative, advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: KEYNOTE-859, Pembrolizumab (pembro) or placebo added to docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) previously treated with next-generation hormonal agents (NHAs): KEYNOTE-921 phase III study, ENGOT-cx11/KEYNOTE-A18: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab With Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer, LAURA: Osimertinib maintenance following definitive chemoradiation therapy (CRT) in patients (pts) with unresectable stage III epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), Interpreting Oncological Study Publications, Cancer Diagnosis and Treatment Evaluation, Rehabilitation Issues During Cancer Treatment and Follow-Up, Cancer Treatment in Special Clinical Situations, Clinical Pharmacology of Anti-Cancer Agents, ESMO Members: Build Your Own ESMO Library, International Prognostic Index Tools for Lymphoma, Anti-Cancer Agents and Biological Therapy, Drug-Drug Interactions with Kinase Inhibitors, PARP inhibition and DNA Damage Response (DDR), Cancer Aetiology, Epidemiology and Prevention, Cancer in Special situations (pregnancy, young, elderly, hereditary...), Multikinase Inhibitor-Related Skin Toxicity, Precision Medicine and Validated Biomarkers, ESMO Recommendations in Precision Medicine, Translational Research: Biomarkers & Diagnostics. S-E. Al-Batran: Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Celgene; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Nordic Pharma; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: MSD Sharp & Dohme; Speaker Bureau/Expert testimony: AIO gGmbH; Speaker Bureau/Expert testimony: MCI; Speaker Bureau/Expert testimony: promedicis; Speaker Bureau/Expert testimony: Forum für Medizinische Fortbildung; Officer/Board of Directors: IKF Klinische Krebsforschung GmbH; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Vifor; Research grant/Funding (institution): Medac; Research grant/Funding (institution): Hospira; Research grant/Funding (institution): German Cancer Aid (Krebshilfe); Research grant/Funding (institution): German Research Foundation; Research grant/Funding (institution): Federal Ministry of Education and Research. General Information Age Group Adults Status Recruiting Protocol Number NCT03504397 Background Information. Phase II. Randomization will be stratified by region (Asia vs non-Asia), number of metastatic sites (0 to 2 vs ≥3), and prior gastrectomy (yes vs no). S. Kim: Travel/Accommodation/Expenses: Astellas Pharma. A Phase 3 efficacy, safety and tolerability study of zolbetuximab (experimental drug) plus mFOLFOX6 chemotherapy compared to placebo plus mFOLFOX6 as treatment for gastric and gastroesophageal junction (GEJ) cancer. May 25, 2020. A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer: Fluorouracil (DB00544) Leucovorin (DB00650) Oxaliplatin (DB00526) Zolbetuximab (DB15118) NCT03653507 Zolbetuximab has been investigated in 4 clinical trials, of which 4 are open and 0 are closed. is primarily based on Part 2 of the phase 2b trial, KCP-330-012 (STORM). A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer F. Lordick: Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol Myers Squibb; Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Eli Lilly; Travel/Accommodation/Expenses: Elsevier; Travel/Accommodation/Expenses: Biontech GmbH; Travel/Accommodation/Expenses: Excerpta Medica; Travel/Accommodation/Expenses: Medscape; Travel/Accommodation/Expenses: E-Cancer; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: Merck Serono; Travel/Accommodation/Expenses: Merck Sharpe Dohme; Travel/Accommodation/Expenses: Springer Nature Verlag GmbH. As of June 30, 2020, 190 sites have been initiated. A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer Zolbetuximab (zolbe), a chimeric IgG1 monoclonal antibody, binds to CLDN18.2 and mediates cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

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