A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI.
Name: Pemetrexed
Name: Cisplatin 75mg/m2
Name: AC0010
Description: To assess the Progression-Free Survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure: Progression-Free Survival (PFS) Time: From the date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 24 months.Description: To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure: Objective Response Rate (ORR) Time: Baseline up to 28 days after completion of study drug, assessed up to 24 months.Description: To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure: Duration of Response (DoR) Time: From occurring of CR or PR until progression or the date of death from any cause, whichever came first, assessed up to 24 months.Description: To assess the Disease Control Rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure: Disease Control Rate (DCR) Time: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.Description: To assess the Overall Survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure: Overall Survival (OS) Time: From the date of randomization to death or end of study, which is assessed up to 36 months.Description: To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure: Patient Reported Outcomes by EORTC QLQ-C30 Questionnaire Time: Baseline up to 28 days after completion of study drug, assessed up to 24 months.Description: Clinical chemistry, hematology, urinalysis, vital signs, physical examination, weight, ECG and ECOG Performance status and adverse event will be used to assess safety endpoints.
Measure: Incidence of toxicity, grading with CTCAE 4.03 Time: From the date of randomization until end of treatment,which is assessed up to 24 monthsAllocation: Randomized
Crossover Assignment
There are 3 SNPs
6. Confirmation of tumor EGFR sensitive mutation positive in previous tumor samples, including G719X, exon 19 deletion, L858R, L861Q. --- L858R ---
6. Confirmation of tumor EGFR sensitive mutation positive in previous tumor samples, including G719X, exon 19 deletion, L858R, L861Q. --- L858R --- --- L861Q ---
To assess the Progression-Free Survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Objective Response Rate (ORR). --- T790M ---
To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Duration of Response (DoR). --- T790M ---
To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Disease Control Rate (DCR). --- T790M ---
To assess the Disease Control Rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Overall Survival (OS). --- T790M ---
To assess the Overall Survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Patient Reported Outcomes by EORTC QLQ-C30 Questionnaire. --- T790M ---
To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).. Incidence of toxicity, grading with CTCAE 4.03. --- T790M ---
7. Confirmation of tumor harboring of T790M mutation by central lab with a biopsy sample taken after failure of first generation EGFR TKIs. --- T790M ---
Patients must provide a biopsy for central confirmation of T790M mutation positive. --- T790M ---