A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
* Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after \>12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
* Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
* Have adequate organ function.
* Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
* Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria:

* Participants with adenocarcinoma of the esophagus are excluded.
* Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
* Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
* Have radiation therapy within 14 days prior to randomization.
* Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
* Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization.
* Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
* Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
* Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
* Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter \[PICC\] line) and the investigator does not anticipate any significant bleeding.
* Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
* Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
* Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
* The participant has:

  * cirrhosis at a level of Child-Pugh B (or worse) or
  * cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
* Have known allergy or hypersensitivity to any components of study treatment.
* Are pregnant or lactating.