Hoosier Cancer Research Network investigators presented the ongoing study LUN18-335, RAMOSE: An open-label randomized Phase II study of osimertinib with or without ramucirumab in TKI-naïve EGFR-mutant metastatic non-small cell lung cancer (NSCLC), during the World Conference on Lung Cancer earlier this year.

Led by Xiuning Le, MD, PhD, of the University of Texas MD Anderson Cancer Center, the goal of this multicenter study is to determine the efficacy of the combination of osimertinib and ramucirumab in treatment-naïve EGFR-mutant non-small cell lung cancer. An earlier phase I study demonstrated the safety and feasibility of this combination.

LUN18-335 is a randomized, open-label phase 2 study comparing osimertinib 80mg daily + ramucirumab 10 mg/kg every weeks (O+R) to osimertinib 80mg daily monotherapy (O) for initial treatment of metastatic EGFR-mutant NSCLC. Patients are randomized 2:1 to the O+R versus O groups, with stratification based on type of EGFR mutation and presence of central nervous system metastasis. The trial will enroll a total of 150 patients, allocating 100 to O+R and 50 to O monotherapy. The primary endpoint is progression-free survival.

At the time the abstract was published, 29 patients had been accrued: 17 subjects randomized to the O+R arm and 8 to the O arm. Early analysis from the RAMOSE trial shows no unexpected signals of toxicity with the combination of O+R. Enrollment for the trial is ongoing.

Sites participating in the study include: Columbia University Irving Medical Center; Fred Hutchinson Cancer Research Center; Georgetown Lombardi Comprehensive Cancer Center; Indiana University Melvin and Bren Simon Comprehensive Cancer Center; John Theurer Cancer Center at Hackensack University; MD Anderson Cancer Center; Moffitt Cancer Center; New York University Langone Perlmutter Cancer Center; Providence Cancer Institute; Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Rush University Medical Center; Summit Health; and the University of Virginia Cancer Center.

Study authors include: Andreas Saltos, MD; Christina Baik, MD, PhD; Rachel E. Sanborn, MD; Elaine Shum, MD; Chul Kim, MD, MPH; Richard D. Hall, MD; Mary Jo Fidler, MD; Catherine Ann Shu, MD; Gregory A. Otterson, MD; Jyoti Patel, MD; Kwok-Kin Wong, MD, PhD; Nasser H. Hanna, MD; Jhanelle Gray, MD; John V. Heymach, MD, PhD; and Xiuning Le, MD, PhD.

Support for this study is provided by Eli Lilly and Company.

See abstract.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.