Although the number of new cases of lung cancer decline every year, in part because fewer people are smoking, lung cancer remains the second most common cancer and the leading cause of cancer death in the United States, in both women and men.
When lung cancer spreads into other parts of the body, it’s considered “advanced” or metastatic. Nearly 85 percent of patients with advanced lung cancer have non-small cell lung cancer (NSCLC). Several factors, including tumor size and where the cancer has spread in the body (metastasized), determine the prognosis and possible treatments.
A new phase 3 study at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute, tests the effectiveness of amivantamab, an experimental treatment, given with standard care chemotherapy to inhibit tumor growth in people with NSCLC.
The study is open to people with advanced or metastatic NSCLC whose cancers have a specific mutation in the DNA of their cancer cells, called the epidermal growth factor receptor Exon 20 insertion, and have not been treated with chemotherapy.
Rachel E. Sanborn, M.D., is the principal investigator of the study. She is medical director of the Providence Thoracic Oncology Program and the Phase I Clinical Trials Program. Full details of the study are available here:
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Purpose of the study
This study compares the effectiveness of using amivantamab in combination with chemotherapy, versus chemotherapy alone as the first treatment for people with newly diagnosed stage IV NSCLC that demonstrates the EGFR Exon 20 mutation. Amivantamab is a bi-specific antibody that targets epidermal growth factor receptor and a protein called MET to inhibit tumor growth.
Amivantamab received accelerated approval by the U.S. Food and Drug Administration for the treatment of metastatic Exon 20 mutated-NSCLC that has been previously treated with chemotherapy. The approval is based on study results published in the Journal of Clinical Oncology by investigators, including Dr. Sanborn, who showed that the treatment provides a benefit to people with stage IV NSCLC with the Exon 20 mutation whose cancers progressed after chemotherapy.
The study includes two arms: amivantamab and chemotherapy, or chemotherapy only (the current standard of care treatment in this setting). Participants are randomly assigned to an arm. Both arms involve treatment; there is no placebo arm.
Who can participate?
The following factors determine a participant’s eligibility in the study:
- Confirmed, locally advanced or metastatic, non-small cell lung cancer with documented primary epidermal growth factor receptor Exon 20 mutation that has not yet been treated with chemotherapy.
- Tumor that can be accurately measured.
- Participant must agree to a pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
See more studies
This study is one of 30 lung cancer studies currently open at Providence Cancer Institute. New research studies are added frequently. Please visit our website to see all open lung cancer studies.
See all studies in all cancer types at Providence Cancer Institute.
Multidisciplinary lung cancer management
The Providence Thoracic Oncology Program emphasizes a multidisciplinary approach to cancer treatment and care, at every phase of the patient journey. Our clinical trials program offers a broad array of innovative clinical research, including studies of new surgical techniques, radiation, chemotherapy, targeted therapy and immunotherapy agents, and tissue banking.
For more information or to refer patients to this study, please call 503-215-2614 or email our Clinical Research office.