This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment.
Name: CT053PTSA
Type: DrugCT053PTSA (dose 1)+Gefitinib 250mg CT053PTSA (dose 2)+Gefitinib 25mg
Name: Gefitinib
Type: DrugCT053PTSA (dose 1)+Gefitinib 250mg CT053PTSA (dose 2)+Gefitinib 25mg
Description: The maximum tolerated dose (MTD) of the CT053PTSA and gefitinib combination will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.03
Measure: Part 1(dose-escalation part): Maximum Tolerated Dose (MTD) Time: Cycle 1 Day 1 to Cycle 1 Day 28Description: Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1
Measure: Part 2(expansion part): Overall Response Rate Time: up to approximately 36 monthsDescription: Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs
Measure: Number of patients with adverse events (AEs) as a measure of safety and tolerability Time: up to approximately 36 monthsDescription: DCR, proportion of patients with best overall response of CR, PR or SD
Measure: Disease Control Rate (DCR) Time: up to approximately 36 monthsDescription: PFS, defined as time from date of treatment to disease progression or death due to any cause
Measure: Progression-free Survival (PFS) Time: up to approximately 36 monthsDescription: DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause
Measure: Duration of Response (DOR) Time: up to approximately 36 monthsDescription: OS, defined as time from date of treatment to death due to any cause
Measure: Overall Survival (OS) Time: up to approximately 60 monthsDescription: to assess the pharmacokinetic profile
Measure: Maximum observed plasma concentration (Cmax) Time: Cycle 1 Day1 and Day 28Description: to assess the pharmacokinetic profile
Measure: Time of maximum observed plasma concentration (Tmax) Time: Cycle 1 Day1 and Day 28Description: to assess the pharmacokinetic profile
Measure: Area under the plasma concentration time curve (AUC) Time: Cycle 1 Day1 and Day 28Allocation: Non-Randomized
Parallel Assignment
There is one SNP
A Phase Ib, Multi-center, Open Label Study of Ningetinib (CT053PTSA) in Combination With Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative Who Have Progressed After EGFR TKI Therapy. --- T790M ---
Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment. --- T790M ---
Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment. --- T790M --- --- T790M ---
Inclusion Criteria: - Histologically or cytologically confirmed Stage IIIB or IV NSCLC - Acquired resistance to EGFR TKI (1st, 2nd or 3rd generation) - Histological or cytological evidence of EGFR mutation and T790M negative after progression on last EGFR TKI therapy - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Toxicity recovered to NCI CTCAE v.4.03 --- T790M ---
- Serious electrolyte imbalance in the investigator's judgment - Pregnant or lactating woman - Any other reason the investigator considers the patient is not suitable to participate in the study Inclusion Criteria: - Histologically or cytologically confirmed Stage IIIB or IV NSCLC - Acquired resistance to EGFR TKI (1st, 2nd or 3rd generation) - Histological or cytological evidence of EGFR mutation and T790M negative after progression on last EGFR TKI therapy - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Toxicity recovered to NCI CTCAE v.4.03 --- T790M ---
The part 2 portion of this study will continue to evaluate the safety and efficacy of the combination of CT053PTSA and gefitinib , at the appropriate doses recommended in Part 1, in patients with EGFR mutation, T790M negative NSCLC. --- T790M ---