To compare efficacy and safety of Abivertinib maleate alone versus standard first-line EGFR-TKIs for the treatment of patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Name: Abivertinib Maleate Capsules
Name: Placebo Gefitinib Tablets
Name: Gefitinib Tablets
Name: Placebo Abivertinib Maleate Capsules
Description: Progression-free survival (PFS) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation (Investigator's evaluation according to RECIST1.1 criteria)
Measure: Assess the efficacy of Abivertinib: Progression Free Survival (PFS) Time: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 monthsDescription: Objective Response Rate (ORR) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Measure: Objective Response Rate (ORR) Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)Description: Disease Control Rate (DCR) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Measure: Disease Control Rate (DCR) Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)Description: Duration of Response (DoR) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Measure: Duration of Response (DoR) Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)Description: Overall Survival (OS) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Measure: Overall Survival (OS) Time: From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 36 months)Description: Number and severity of AEs/SAEs of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Measure: Safety and Resistance: Number and severity of AEs/SAEs Time: From screening to the end of survival follow-up, which is assessed through study completion until 30 days after discontinuationDescription: The mean, standard deviation, maximum, minimum, and median of drug exposures in the two groups are described
Measure: Safety and Resistance: Drug exposure Time: Continuously throughout the study until 30days after discontinuationDescription: A general physical examination includes: general status, skin, head and neck (includes: eyes, ears, nose, throat), respiratory system, cardiovascular system, abdomen,superficial lymph nodes, thyroid, musculoskeletal system (including spine and limbs), and nervous system, and any other physical signs of clinical significance. During the treatment, physical examination of the potentially affected organs will be performed.
Measure: Safety and Resistance: General physical examination status Time: Continuously throughout the study until 30days after discontinuationDescription: Descriptive statistical analysis of clinical diagnosis results of ECG examination and changes compared with baseline are performed at planned time points, and abnormal ECG examination results are listed.
Measure: Safety and Resistance: Electrocardiogram(ECG test) Time: Continuously throughout the study until 30days after discontinuationDescription: ECOG (Eastern Clinical Oncology Group) Performance Status Grading Criteria: Range from 0-5, 0 considered to be the best outcome and 5 to be the worst outcome
Measure: Safety and Resistance: Eastern Clinical Oncology Group Scores Time: Continuously throughout the study until 30days after discontinuationDescription: Quality of life questionnaire of Abivertinib maleate alone versus standard which includes 5 functional domains, 3 symptom domains, 1 overall health status/quality of life domain and 6 single entries. Standardized scores of the domains/single entries in the questionnaire are used to statistically describe the absolute values and changes from baseline at each evaluation time point; t test is used to compare changes from baseline in overall quality of life score at each evaluation time point in both groups; analysis of variance is used to compare changes in overall health status score at each evaluation time point between the two groups. first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation
Measure: Questionnaire: Health-related quality of life (HRQoL) Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)Allocation: Randomized
Parallel Assignment
There is one SNP
4. Tumor tissue or cytopathological specimens have any of two common sensitive EGFR mutation (Ex19del or L858R) as confirmed by tests with Cobas (Roche) kit in central lab of this study, which can be combined with other EGFR gene mutations. --- L858R ---