Looking at Osimertinib Alone or With Chemotherapy for Lung Cancer Treatment

Recruiting · Phase 2 · Metastatic Non-small Cell Lung Cancer · 9 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This 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.

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.

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.

Condition

Metastatic Non-small Cell Lung Cancer

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

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.