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 1

NCT02572687

Gastric Cancer, Hepatocellular Carcinoma, or NSCLC

VEGF Receptor-2 Antagonist


An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus MEDI4736 in Patients With Locally Advanced and Unresectable or Metastatic Gastrointestinal or Thoracic Malignancies*

NCT02572687
Key Inclusion Criteria
  • Measurable metastatic disease or locally advanced and unresectable disease of the following types:
    • Gastric/gastroesophageal junction (GEJ) adenocarcinoma with documented disease progression after one to two prior lines of systemic therapy
    • Non-small cell lung cancer (NSCLC) with documented disease progression after one to three prior lines of systemic therapy
    • Hepatocellular carcinoma (HCC): Child-Pugh class A with documented disease progression after discontinuation of sorafenib therapy, or intolerance to sorafenib therapy, and alpha-fetoprotein ≥1.5× upper limit of normal
  • Availability of tumor tissue for biomarker analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
Key Exclusion Criteria
  • Known brain metastases
  • History of prior cancers not included in this study that either were not treated with curative intent or have been active within the past 5 years
  • History of allogeneic organ transplant
  • Active or prior documented autoimmune disease within the past 24 months
  • Current HIV infection or AIDS-related illness, or a history of immunodeficiency
  • Active hepatitis B or C infection, or coinfection with both hepatitis B and C virus
  • For gastric/GEJ and NSCLC participants, chronic hepatitis B or C infection. For HCC participants, those with chronic hepatitis B virus (HBV) infection with a negative HBV DNA test and who are on antiviral therapy and those with chronic hepatitis C virus infection are eligible
  • History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis, noninfectious pneumonitis, or radiation-induced or drug-induced pneumonitis
  • Prior systemic therapy targeting PD-1 or PD-L1/2 signaling pathways, and other immune checkpoint inhibitors
  • Prior systemic therapy with ramucirumab
*
This clinical trial is being conducted globally in partnership with AstraZeneca.
Ramucirumab is administered intravenously (IV) Q3W over a 21-day cycle.
MEDI4736 is administered IV Q3W over a 21-day cycle.
§
Ramucirumab is administered IV Q3W over a 21-day cycle.
MEDI4736 is administered IV Q2W over 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.