Study on Patritumab Deruxtecan for Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT04619004
This clinical trial is testing a new treatment, patritumab deruxtecan, for patients with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation and has not responded to previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the effectiveness of patritumab deruxtecan in shrinking tumors in patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. Participants must have already tried at least one EGFR-targeted therapy and one platinum-based chemotherapy, but their cancer has continued to grow.
Description
In this study, participants will be randomly assigned to one of two groups to receive different doses of the study drug, patritumab deruxtecan. The goal is to determine which dose is more effective and safe for treating advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
- Cancer must have continued to grow after previous treatments, including osimertinib and at least one platinum-based chemotherapy.
- Have a specific EGFR mutation (exon 19 deletion or L858R) confirmed by tests.
- Have at least one tumor that can be measured by scans.
- Be willing to provide a tumor sample for testing.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood cell counts and organ function as determined by specific blood tests.
Exclusion Criteria
- Have a history of small cell lung cancer or a combination of small cell and non-small cell lung cancer.
- Have a history of lung diseases like interstitial lung disease or pulmonary fibrosis.
- Have severe breathing problems due to lung conditions or other illnesses.
- Be taking high doses of steroids or other immune-suppressing medications.
- Have cancer that has spread to the brain or spinal cord and is causing symptoms.
- Have not waited long enough after previous treatments before starting the study.
- Have previously received certain types of cancer treatments, including HER3 antibodies or topoisomerase I inhibitors.
- Have unresolved side effects from previous cancer treatments.
- Have had another active cancer within the past 3 years, except for certain non-threatening cancers.
- Have uncontrolled heart disease or active infections like hepatitis B, hepatitis C, or HIV.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| City of Hope | 91010 | Duarte | California |
| Moores Cancer Center at the UC San Diego Health | 92093 | La Jolla | California |
| Pacific Shores Medical Group | 90813 | Long Beach | California |
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of California at Irvine | 92868 | Orange | California |
| Cedars Sinai | 90048 | West Hollywood | California |
| University of Colorado Denver - Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Florida Cancer Specialists - South | 33901 | Fort Myers | Florida |
| AdventHealth Orlando | 32804 | Orlando | Florida |
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