This phase 3 trial will investigate the safety and effectiveness of osimertinib (Tagrisso) after chemoradiation (CR) in non-small cell lung cancer (NSCLC). The main outcome will be progression-free survival (PFS; survival without cancer growing or spreading).
The details
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer (LC). Some patients with NSCLC have abnormal genes that cause tumors to grow rapidly. Mutations in the epidermal growth factor receptor (EGFR) gene are common in NSCLC. Drugs that target EGFR mutations may slow cancer cell growth. Osimertinib is a drug that targets EGFR mutation-positiveNSCLC. Osimertinib is already licensed to treat NSCLC. It is unclear if osimertinib.is safe and effective in NSCLC patients that have also undergone chemoradiation (CR).
This trial will investigate the safety and effectiveness of osimertinib after CR in NSCLC. The main outcome will be PFS.
Who are they looking for?
This trial will recruit 200 patients with Stage III NSCLC that cannot be surgically removed. The cancer must be positive for EGFR. Patients must have already received CR more than 6 weeks before the trial. Female participants must use highly effective contraceptive measures during the study.
Patients with CR side effects that have not resolved cannot take part in the trial. Other exclusion criteria include issues with heart or other organ function; a history of other cancers, uncontrolled diseases, active infections, treatment with other EGFR-targeted drugs, recent major surgery.
How will it work
Patients will be randomly assigned to one of two groups. One group will receive osimertinib. The other group will receive placebo (inactive drug). Treatment will be administered orally once daily. The initial dose of 80 mg may be reduced to 40 mg. This will be done if the side effects are unacceptable to the patient or doctor.
