Study Comparing Amivantamab with Chemotherapy to Chemotherapy Alone in Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT04538664
This clinical trial is evaluating whether adding the drug amivantamab to standard chemotherapy can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation known as EGFR Exon 20 insertions.
Patient Parameters
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Program Overview
The aim of this study is to determine if combining the drug amivantamab with chemotherapy is more effective in extending the time patients live without their cancer worsening, compared to chemotherapy alone. This study focuses on patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR Exon 20 insertions.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic mutation known as EGFR Exon 20 insertions.
- Have measurable cancer according to standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Agree to have genetic testing of the tumor through a biopsy before starting treatment, and provide blood samples during the study to monitor tumor mutations.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to regular pregnancy tests during the study.
Exclusion Criteria
- Have another type of non-small cell lung cancer (NSCLC) at the same time.
- Have untreated brain metastases, unless they have been treated and are stable without symptoms or steroid use for at least two weeks.
- Have a history of spinal cord compression that has not been treated with surgery or radiation.
- Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
- Cannot take carboplatin or pemetrexed due to medical reasons or allergies, or have allergies to vitamin B12 or folic acid.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope 2 | 91010 | Duarte | California |
| University of California Irvine | 92868 | Orange | California |
| UCLA | 90404 | Santa Monica | California |
| Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| H. Lee Moffitt Cancer & Research Institute | 33612 | Tampa | Florida |
| University Cancer And Blood Center LLC | 30607 | Athens | Georgia |
| Henry Ford Hospital | 48202 | Detroit | Michigan |
| Washington University Medical Center | 63110 | St Louis | Missouri |
| Regional Cancer Care Associates LLC | 08816 | East Brunswick | New Jersey |
| Langone Health at NYC University, NYU School of Medicine | 10016 | New York | New York |
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