Looking at Osimertinib Alone or With Chemotherapy for Lung Cancer Treatment
NCT04410796 · RecruitingThis study is looking at how well osimertinib works alone versus when it is combined with chemotherapy in adults with lung cancer that has specific changes in the EGFR gene. Osimertinib is already a common treatment for this type of lung cancer. Researchers hope that adding chemotherapy could make the treatment even more effective in stopping the cancer from growing or spreading.
Locations and contact
This trial is running at 18 locations. The first 8 are listed here.
- UC Davis Cancer Center (Data Collection Only)Sacramento, CaliforniaRecruiting
- University of California San FranciscoSan Francisco, CaliforniaActive, not recruiting
- Moffitt Cancer CenterTampa, FloridaRecruiting
- John Hopkins Medical CenterBaltimore, MarylandRecruiting
- Massachusetts General Hospital (Data Collection Only)Boston, MassachusettsRecruiting
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New JerseyRecruiting
- Hackensack Meridian HealthHackensack, New JerseyRecruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New JerseyRecruiting
Who can join
Adults aged 18 and older can join. They must have biopsy-proven metastatic non-small cell lung cancer with an EGFR mutation. Participants should not have had chemotherapy for metastatic disease and must meet certain health criteria. The trial is open to both men and women and the trial team will confirm eligibility.
What happens during the trial
Participants will start by taking osimertinib alone for a few cycles. Then, they will be randomly assigned to one of two groups: one group will continue with osimertinib alone, while the other group will receive osimertinib along with chemotherapy drugs, carboplatin and pemetrexed. Everyone will take osimertinib daily, and those receiving chemotherapy will have additional treatments every few weeks.
The trial team
The trial is sponsored by Memorial Sloan Kettering Cancer Center, with collaboration from AstraZeneca and Guardant Health, Inc. Dr. Helena Yu is the principal investigator leading the study.
Important dates
The trial began on May 28, 2020, and is expected to finish in May 2027. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT04410796. It is a Phase 2 trial, which means it is looking at how well the treatment works and its safety. The trial is FDA-regulated and plans to include 571 participants.
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