Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.
Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;
Gene text confirmed EGFR mutation;
PET-CT confirmed no metastasis;
ECOG physical status score 0-1;
Patients with other malignant tumors in the five years before the start of this trial.
Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
Single group
Osimertinib
DrugPatients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks).
Objective Response Rate, ORR
Defined as the proportion of participants who had a complete response (CR) or partial response (PR) according to RECIST version 1.1 after treatment.
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
Major pathologic response, MPR
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
R0 rate
There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope.
Progression-free survival (PFS)
PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.
Overall survival (OS)
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
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