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 therapy, hormonal therapy or surgery) while taking investigational treatment.
• Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
• Prior palliative chemotherapy for the treatment of gastric cancer.
• Prior treatment with oxaliplatin-based neoadjuvant or adjuvant chemotherapy completed <12 months.
• Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn's disease or ulcerative colitis).
• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
• Uncontrolled infection.
• History of other malignancy. However, subjects who were disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, were eligible.