Phase III Study Comparing Datopotamab Deruxtecan and Docetaxel for Advanced TROP2-positive Non-squamous Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07291037
This clinical trial is testing the effectiveness and safety of a new drug, datopotamab deruxtecan, compared to the standard treatment, docetaxel, for patients with advanced lung cancer that is TROP2-positive and does not have certain genetic changes.
Patient Parameters
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Program Overview
The TROPION-Lung17 study aims to find out if the new drug datopotamab deruxtecan (Dato-DXd) is more effective and safer than the standard drug docetaxel for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is TROP2-positive and lacks specific genetic changes that can be targeted by other treatments.
Description
This study is a Phase III trial, meaning it is in the later stages of testing. It involves two groups of participants: one group will receive the new drug datopotamab deruxtecan (Dato-DXd), and the other will receive the standard treatment, docetaxel. The study is open-label, so both the participants and the researchers know which treatment is being given. The trial is being conducted at multiple centers and focuses on patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is TROP2-positive and does not have certain genetic changes that can be treated with other drugs. The study will also evaluate a diagnostic test used to identify TROP2-positive patients.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without specific genetic changes that can be treated with targeted therapies.
- Must test negative for certain genetic changes, including EGFR, ALK, and ROS1.
- Cancer must be TROP2-positive.
- Disease must have worsened after previous treatment.
- Must have received platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 treatment.
- Provide a tumor sample for TROP2 testing.
- Have at least one measurable tumor that has not been treated with radiation.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Have adequate bone marrow and organ function.
Exclusion Criteria
- Have a different type of lung cancer, such as squamous or small cell lung cancer.
- Have lung cancer that can be treated with local therapy alone.
- Have had another cancer within the last 3 years, unless it was treated and is not active.
- Have untreated or unstable brain or spinal cord tumors.
- Have significant eye disease affecting the cornea.
- Have active hepatitis B or C infection.
- Have uncontrolled HIV infection.
- Have an uncontrolled infection requiring IV treatment.
- Have a history of lung disease that required steroids or have current lung disease that cannot be ruled out.
- Have severe lung function issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85224 | Chandler | Arizona |
| Research Site | 85234 | Gilbert | Arizona |
| Research Site | 85338 | Goodyear | Arizona |
| Research Site | 91010 | Duarte | California |
| Research Site | 92618 | Irvine | California |
| Research Site | 92093 | La Jolla | California |
| Research Site | 92350 | Loma Linda | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 92123 | San Diego | California |
| Research Site | 81501 | Grand Junction | Colorado |
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