LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Key inclusion criteria: * Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction. * Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease. * Measurable or non-measurable, but radiologically evaluable disease, according to RECIST. * HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible. * Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization. * Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO). * Prior/Concurrent Therapy: * At least 3 weeks following major surgery, such as gastrectomy, and were recovered from any related toxicity More than 5 years since prior chemotherapy for malignancy other than GC. At least 4 weeks since prior radiotherapy * More than 5 years since prior biologic or hormonal therapy or immunotherapy for malignancy other than gastric carcinoma. Key exclusion criteria: * Pregnant or lactating females at any time during the study. * Known history of active CNS disease. * Uncontrolled ascites. * Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic ther…