This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Oral
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.
Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles
BeijingCancerH
Beijing, China
RECRUITINGMajor 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 randomization 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 randomization to an average of 12 weeks after the first dose
Overall Survival (OS)
Defined as the time from the date of entry to the date of death from any cause.
Time frame: Up to approximately 5.5 years after the last patient is randomized
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 randomization up to approximately 42 months after date of resection
Objective response rate(ORR)
ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.
Time frame: Baseline (Prior to surgery)
Disease control rate(DCR)
DCR is defined as the percentage of participants having a complete response , a partial response and disease stability measured by RECIST 1.1.
Time frame: Baseline (Prior to surgery)
R0 surgical resection rate
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Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 2 cycles
the proportion of resection margin without macroscopic or microscopic tumor residue (negative resection margin)
Time frame: Post surgery (within one week)
Incidence of Adverse Events
AE captured by CYCAE 5.0
Time frame: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery