Phase III Study of Osimertinib With or Without Datopotamab Deruxtecan for Advanced Non-small Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06350097
This clinical trial is testing the effectiveness and safety of a combination of two drugs, osimertinib and Datopotamab Deruxtecan, compared to osimertinib alone, as a first treatment for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if combining the drug osimertinib with Datopotamab Deruxtecan is more effective than using osimertinib alone for treating advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations. Participants will receive treatment until their cancer progresses, they experience unacceptable side effects, or meet other criteria for stopping treatment. The study will last approximately 9 years, with regular visits every 3 weeks during treatment. For those on osimertinib alone, visits will be every 6 weeks after a certain point, and then every 12 weeks until the cancer progresses or treatment is stopped.
Description
This global study is in Phase III and involves multiple centers. It is open-label, meaning both the participants and researchers know which treatment is being given. The study is comparing the combination of osimertinib and Datopotamab Deruxtecan to osimertinib alone in patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. Participants have not received any prior treatment for their advanced cancer. The study will assess how well the treatments work and their safety.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older (20 years or older in Japan).
- Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
- Have advanced or metastatic NSCLC that cannot be treated with surgery or radiation.
- Have not received prior treatment with EGFR TKIs or other systemic therapy for advanced NSCLC.
- Have a tumor with specific EGFR mutations (Ex19del or L858R).
- Provide a tumor sample for confirmation of EGFR mutation status.
- Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one measurable tumor that has not been treated with radiation.
- Have adequate bone marrow and organ function.
- Use contraception if of childbearing potential, according to local regulations.
- Open to all races, genders, and ethnic groups.
Exclusion Criteria
- Have severe or uncontrolled diseases, history of organ transplant, or substance abuse that could interfere with the study.
- Have digestive issues that prevent taking the study drug.
- Have another primary cancer.
- Have spinal cord compression or unstable brain metastases.
- Have significant eye disease.
- Have active or uncontrolled hepatitis B or C, or uncontrolled HIV.
- Have an uncontrolled infection or require intravenous antibiotics.
- Have abnormal heart tests or significant heart disease.
- Have a history of lung disease requiring steroids.
- Have severe lung function issues.
- Have previously received certain cancer treatments targeting topoisomerase I or TROP2.
- Have severe allergies to the study drugs or similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90720 | Los Alamitos | California |
| Research Site | 90017 | Los Angeles | California |
| Research Site | 90033 | Los Angeles | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 92868 | Orange | California |
| Research Site | 92123 | San Diego | California |
| Research Site | 06510 | New Haven | Connecticut |
| Research Site | 20037 | Washington | District of Columbia |
| Research Site | 32256 | Jacksonville | Florida |
| Research Site | 34474 | Ocala | Florida |
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