This is a multicenter, randomized, controlled, phase II study assessing the efficacy and safety of Almonertinib compared Erlotinib or platinum doublet chemotherapy (carboplatin or cisplatin + pemetrexed) as neoadjuvant therapy to EGFRm+ IIIA-N2 NSCLC patients.
Name: Almonertinib
Name: Erlotinib
Name: Cisplatin
Name: Carboplatin
Name: Pemetrexed
Description: Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
Measure: Objective response rate (ORR) Time: From date of randomization to an average of 6 weeks after the first doseDescription: Defined as absence of any residual cancer cells in the surgical specimen assessed post-surgery
Measure: Pathological complete response (pCR) Time: From date of randomization to an average of 12 weeks after the first doseDescription: Defined as ≤10% residual cancer cells in the surgical specimen, as assessed per central pathology laboratory post-surgery
Measure: Major Pathological Response (MPR) Time: From date of randomization to an average of 12 weeks after the first doseDescription: 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. If there is residual disease after surgery (eg. positive margins), the DFS event is the date of surgery.
Measure: Disease free survival (DFS) Time: From date of randomization up to approximately 18 months after date of resectionDescription: Patients will be followed up to approximately 5.5 years after they are randomized.
Measure: Overall Survival (OS) Time: Up to approximately 5.5 years after the last patient is randomizedDescription: Measured using lymph node staging
Measure: Downstaging rate Time: From date of randomization to an average of 12 weeks after the first doseDescription: According to CTCAE4.0
Measure: Incidence of Adverse Events (AEs) Time: Up to 80 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
3. Tumor tissue samples or blood samples are confirmed as EGFR sensitive mutations by central laboratory tests (including Ex19del or L858R, both alone or with other EGFR mutations). --- L858R ---