This trial is being carried out to assess whether osimertinib (Tagrisso) should be used alone or with chemotherapy for lung cancer and abnormalities (mutations) in the EGFR gene. The main outcome that will be measured in this trial is survival without progression of the disease. This trial will take place in New Jersey and New York, US.
The details
Lung cancer is one of the most common forms of cancer worldwide. It remains a difficult disease to treat. A standard form of care is chemotherapy, surgical removal of tumors, and radiotherapy (high-dose radiation to kill cancer cells). EGFR-mutant lung cancer is a type of lung cancer that has abnormalities in the EGFR (epidermal growth factor receptor) gene. These cells often grow at an uncontrolled rate. Osimertinib is a medication used to treat non-small-lung cancers (NSCLC). It blocks the EGFR receptor on cells and stops the growth of these cancerous cells.
This trial will evaluate if osimertinib works better alone or in combination with chemotherapy. The main outcome of this trial is to measure the length of time that a patient survives without the progression of cancer following treatment.
Who are they looking for?
This trial is looking to recruit 571 patients with metastatic (spread) non-small cell lung cancer (NSCLC). The inclusion criteria for this trial are confirmed EGFR mutations and no prior anti-EGFR treatment. Participants also must not have had previous treatment for metastatic disease and must be able to swallow oral medications, have adequate liver, kidney, and bone marrow function. Participants must be willing to use birth control methods if the patient is of child-bearing age or the patient's partner is of child-bearing potential.
Patients will be excluded from this if they are pregnant or breast-feeding. Patients will also be excluded from this trial if they have had radiotherapy within 1 week of starting this trial, major surgery within 2 weeks prior to starting this trial, and patients with significant heart conditions. Patients with infections such as hepatitis B, C, HIV, or other lung conditions will not be included.
How will it work
There will be two groups in this trial. Group 1 will receive osimertinib 80mg daily. Group 2 will receive osimertinib 80mg daily plus 4 cycles of chemotherapy with carboplatin (Paraplatin) and pemetrexed (Alimta) 500mg/m2.
The objectives that are to be measured are survival without cancer worsening, overall survival, and the overall response to the medication regimens. This will be carried out over a 2-year period.
