Study Comparing Lazertinib with Subcutaneous and Intravenous Amivantamab for EGFR-Mutated Advanced Lung Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05388669
This clinical trial is testing a new way to give the drug amivantamab to patients with advanced non-small cell lung cancer that has specific EGFR mutations. The study aims to see if a new under-the-skin injection method is easier and faster than the traditional intravenous method.
Patient Parameters
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Program Overview
The study is exploring a new formulation of the drug amivantamab, which is given as an injection under the skin, to see if it can simplify the treatment process for patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. This new method could make the treatment experience better for both patients and doctors by making the administration quicker and easier.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations (Exon 19 deletion or Exon 21 L858R mutation) confirmed by a certified lab test.
- Have previously been treated with osimertinib (or another similar drug) and platinum-based chemotherapy.
- Have at least one tumor that can be measured by scans.
- 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.
- Any side effects from previous cancer treatments must have improved to a mild level or returned to baseline, except for hair loss, mild nerve damage, and mild hypothyroidism that is stable with medication.
Exclusion Criteria
- Have received more than one round of platinum-based chemotherapy and EGFR inhibitors.
- Have had radiation therapy for symptom relief less than 7 days before starting the study.
- Have worsening or symptomatic brain metastases.
- Have cancer that has spread to the membranes around the brain or spinal cord that hasn't been treated.
- Have uncontrolled pain related to the tumor.
- Have a history of lung diseases like interstitial lung disease or radiation-induced lung inflammation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Duarte | 91010 | Duarte | California |
| City of Hope Orange County Lennar Foundation Cancer Center | 92618 | Irvine | California |
| City of Hope Long Beach Elm | 90813 | Long Beach | California |
| National Jewish Health | 80206 | Denver | Colorado |
| Baptist Lynn Cancer Institute | 33486 | Boca Raton | Florida |
| Orlando Health | 32806 | Orlando | Florida |
| University of Kansas | 66160 | Kansas City | Kansas |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| Astera Cancer Care | 08816 | East Brunswick | New Jersey |
| Rutgers Cancer Institute of New Jersey | 08901 | New Brunswick | New Jersey |
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