Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 2

NCT02539225

Gastric Cancer

VEGF Receptor-2 Antagonist


A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of S-1 and Oxaliplatin With or Without Ramucirumab as First-line Therapy Followed by Paclitaxel With Ramucirumab as Second-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma*

NCT02539225
Key Inclusion Criteria
  • Metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants with esophageal cancer are not eligible
  • No prior first-line systemic therapy for gastric or GEJ adenocarcinoma (prior neoadjuvant/adjuvant therapy is permitted). Participants whose disease has progressed after >24 weeks following the last dose of systemic treatment in the neoadjuvant/adjuvant setting are eligible
  • Measurable or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Life expectancy of ≥12 weeks
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study period and at least 6 months after the last dose of study treatment or longer if required per local regulations
  • Willing to provide a blood sample for research purposes
Key Exclusion Criteria
  • HER2-positive status. Participants with a negative test or having an indeterminate result due to any reason are eligible, provided these participants are not eligible for treatment directed against tumors that overexpress HER2
  • Radiation therapy within 14 days prior to randomization. Any lesion requiring palliative radiation or that has been irradiated previously cannot be considered for response assessment
  • Documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
  • Major surgery within 28 days prior to randomization
  • Currently enrolled in, or discontinued study drug within the last 28 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the study drug used in this trial), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Those participating in surveys or observational studies are eligible for this study
  • Pregnant or breastfeeding. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to first dose of study treatment
  • Any prior malignancies
  • Any condition that does not permit compliance with the study and follow-up procedures or suggests that the participant is, in the investigator’s opinion, not an appropriate candidate for the study
*
This clinical trial is being conducted outside the United States.
Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met (if in part A, participants move to part B).
Ramucirumab or placebo equivalent is administered intravenously (IV) on days 1 and 8 of a 21-day cycle.
§
S-1 is administered PO on days 1-14 and oxaliplatin is administered IV on day 1 of a 21-day cycle.
Ramcirumab is administered IV on days 1 and 15 of a 28-day cycle.
Paclitaxel is administered IV on days 1, 8, and 15 of a 28-day cycle.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.