This is a randomized, controlled, three-arm, multicenter, phase III study of neoadjuvant osimertinib treatment as monotherapy or in combination with chemotherapy versus SoC chemotherapy alone for the treatment of patients with resectable EGFRm non-small cell lung cancer
Aim of the study
In our research project, we want to find out whether osimertinib (TAGRISSOTM) alone or in combination with chemotherapy is more effective than chemotherapy alone for the treatment of early-stage NSCLC before surgery.
Who can take part?
Patients with EGFRm-positive resectable non-small cell lung cancer
Procedure
If you are eligible for the clinical trial, you will be randomly assigned to one of three treatment options described below:1: Placebo plus chemotherapy, 2: Osimertinib plus chemotherapy, 3: Osimertinib. The two treatment groups with standard chemotherapy consisting of carboplatin or cisplatin and pemetrexed are double-blinded. This means that neither you nor your investigator or other clinical trial staff will know which treatment (osimertinib or placebo) you are receiving until the clinical trial is over. If you are assigned to treatment group 3, both you and your investigator will know which treatment you will receive.
Compensation
None
Original study name
A randomized, controlled, multicenter, 3-arm, phase III study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy versus standard chemotherapy alone for the treatment of patients with epidermal growth factor receptor mutation-positive, resectable non-small cell lung cancer
BASEC number
2020-02696
Financial support from
Astrazeneca