Study on Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy for First-time Treatment of HER2 Overexpressing Non-small Cell Lung Cancer
Sponsor: Daiichi Sankyo
ClinicalTrials ID:NCT06899126
This clinical trial is testing a new combination of drugs, including trastuzumab deruxtecan and pembrolizumab, against the standard platinum-based chemotherapy with pembrolizumab for patients with advanced non-small cell lung cancer (NSCLC) that overexpresses HER2 and has not been treated before.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to compare the effectiveness and safety of a new drug combination, trastuzumab deruxtecan with pembrolizumab, against the standard treatment of platinum-based chemotherapy with pembrolizumab. This trial is for patients with advanced non-small cell lung cancer (NSCLC) that overexpresses HER2 and has not been treated before. The study focuses on patients whose tumors have a HER2 overexpression and a PD-L1 score of less than 50%, and who do not have other genetic alterations that can be treated with available therapies.
Eligibility Criteria
Inclusion Criteria
- Must sign consent forms before any trial procedures.
- Adults aged 18 or older.
- Diagnosed with advanced non-squamous NSCLC that cannot be surgically removed or treated with chemoradiation.
- Cancer must be Stage IV or certain Stage III conditions that are not suitable for surgery or chemoradiation.
- No known genetic alterations that have available targeted therapies.
- No known HER2 mutations.
- Must not have received previous systemic treatment for advanced NSCLC, except under specific conditions.
- Must provide a tumor tissue sample for testing HER2 and PD-L1 levels.
Exclusion Criteria
- Recent heart attack or heart failure within the last 6 months.
- Abnormal heart rhythm as shown by an ECG test.
- History of lung inflammation that required steroids or current lung inflammation.
- Significant lung conditions like recent blood clots, severe asthma, or severe COPD.
- Previous complete removal of a lung.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Oncology & Hematology, LLC | 99508 | Anchorage | Alaska |
| Orange Coast Memorial Medical Center Fountain Valley | 97208 | Fountain Valley | California |
| California Research Institute | 90027 | Los Angeles | California |
| Los Angeles Cancer Network (LACN) | 91204 | Los Angeles | California |
| Providence Medical Foundation | 95403 | Santa Rosa | California |
| Holy Cross Hospital | 33308 | Fort Lauderdale | Florida |
| BRCR Global Plantation | 33321 | Plantation | Florida |
| Clinical Research Alliance | 11590 | Westbury | New York |
| University of Texas M. D. Anderson Cancer Center | 77030 | Houston | Texas |
| Lumi Research | 77339 | Kingwood | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.