This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
80mg/qd oral for 60 days
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.
Pemetrexed (500 mg/m2) to be administered with cisplatin on Day 1 of every 3-week cycle for 2 cycles
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGcomplete lymph node clearance rate
the ratio of ypN0 percentage after resection
Time frame: From date of enrollment to an average of 12 weeks after the first dose
Major Pathological Response (MPR)
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery
Time frame: From date of enrollment to an average of 12 weeks after the first dose
Pathological complete response (pCR)
Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery
Time frame: From date of enrollment to an average of 12 weeks after the first dose
Downstaging
Measured using pathologic mediastinal lymph node evaluation
Time frame: From date of enrollment to an average of 12 weeks after the first dose
Disease free survival (DFS)
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.
Time frame: From date of enrollment up to approximately 42 months after date of resection
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