Study on Osimertinib for Treating Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery
Sponsor: University of California, San Francisco
ClinicalTrials ID:NCT03433469
This clinical trial is testing how well the drug osimertinib works in shrinking tumors in patients with early-stage EGFR-mutant non-small cell lung cancer before they undergo surgery.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of osimertinib, a medication that may help stop the growth of cancer cells by blocking specific signals in cells with EGFR mutations. The trial focuses on patients with stage I-IIIA non-small cell lung cancer who are scheduled for surgery. Participants will take osimertinib daily for up to two cycles, each lasting 28 days, before having their cancer surgically removed. The study will also monitor the safety of the treatment and its impact on the ability to remove tumors surgically.
Description
The main goal of this study is to see how effective osimertinib is when given before surgery to patients with early-stage EGFR-mutant non-small cell lung cancer (NSCLC). Researchers will also look at the safety of the drug and whether it affects the ability to surgically remove tumors. Participants will take osimertinib by mouth once a day for 28 days, and this cycle may be repeated once more if needed. After the treatment, patients will have surgery to remove their cancer. The study will follow up with participants 30 days after treatment and then every three months for up to a year to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Confirmed diagnosis of non-small cell lung cancer (NSCLC) within the last 90 days.
- Cancer must have a specific EGFR mutation.
- Eligible for surgery to remove lung cancer.
- Tumor size must be at least 1 cm in diameter.
- Good overall health with an ECOG performance status of 0 or 1.
- Normal liver and kidney function as indicated by specific blood tests.
- Ability to swallow pills.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days after the last dose of osimertinib.
- Men with partners of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of osimertinib.
Exclusion Criteria
- Cancer that has spread to the brain or other parts of the central nervous system.
- Advanced cancer stages beyond IIIA or distant metastases.
- History of lung diseases like interstitial lung disease or radiation pneumonitis.
- Positive for HIV or active second cancer.
- Taking medications that affect heart rhythm or certain liver enzymes.
- Heart conditions that increase the risk of heart rhythm problems.
- Severe or uncontrolled systemic diseases or infections.
- Pregnant or breastfeeding women.
- Gastrointestinal diseases that affect absorption of oral medications.
- Allergies to osimertinib or similar drugs.
- Participation in another clinical study within the last two months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Davis | 95864 | Davis | California |
| University of California, San Francisco | 94143 | San Francisco | California |
| University of Colorado | 80045 | Aurora | Colorado |
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