Rachel Darwin, Senior Manager, Public Relations
Phase II randomized trial led by investigators at Fox Chase Cancer Center will look at chemotherapy combinations for people with stage IV non-squamous non-small cell lung cancer with EGFR mutation or who never smoked.
PLYMOUTH MEETING, PA [October 28, 2019] — The National Comprehensive Cancer Network (NCCN®) Oncology Research Program (ORP) today announced plans to support a phase II randomized trial for lung cancer patients. The study is titled TH-138: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked. Joseph Treat, MD, Professor, Department of Hematology/Oncology, Fox Chase Cancer Center, will serve as principal investigator, with Hossein Borghaei, DO, and J. Nicholas Bodor, MD, PhD, also from Fox Chase Cancer Center, as co-investigators, along with Jyoti Patel, MD, incoming Assistant Director for Clinical Research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The study is made possible through collaboration with Genentech, who provided funding and study drugs.
“Lung cancer is the leading cause of cancer-related death in the United States and worldwide,” said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. “As advances are made in the development of targeted therapies and immunotherapies, there is opportunity for greatly needed improvement in outcomes.”
Cigarette smoking remains the primary cause of most lung cancer cases, but nearly 20 percent occur in people who have never smoked. Those non-smoking related cancers generally have a different molecular profile than those in smokers, including mutations in the epidermal growth factor receptor (EGFR), and may have variable response to checkpoint inhibitors.
This study will focus on patients whose tumors include an EGFR mutation or who are never smokers (defined as fewer than 100 cigarettes in their lifetime). It will examine whether the anti-PD-L1 inhibitor atezolizumab plus carboplatin, pemetrexed, and bevacizumab will improve progression-free survival and overall survival in this population, as compared to carboplatin, pemetrexed, and bevacizumab.
The study is projected to take 31 months, and include more than 100 patients from across 15-20 cancer centers. It is open to people 18 and older who have not been previously treated with any systemic therapy other than tyrosine kinase inhibitors (TKIs).
The NCCN ORP fosters innovation and knowledge discovery that improve the lives of patients with cancer. Visit NCCN.org/ORP to learn more about past and current clinical investigations.
 Based on the results of IMpower150, a large global Phase 3 study demonstrated that the combination of carboplatin, paclitaxel, bevacizumab and atezolizumab demonstrated clinically meaningful improvements in OS and PFS in patients with EGFR mutations who have failed TKIs, further hypotheses are being evaluated in TH-138. For more information see Socinski M, et al., Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med 2018; 378:2288-2301. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1716948.
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