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Report for Clinical Trial NCT03758287

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03758287 Non-small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: CT053PTSA

Type: Drug
Group Labels: 2

CT053PTSA (dose 1)+Gefitinib 250mg CT053PTSA (dose 2)+Gefitinib 25mg

Name: Gefitinib

Type: Drug
Group Labels: 2

CT053PTSA (dose 1)+Gefitinib 250mg CT053PTSA (dose 2)+Gefitinib 25mg


Primary Outcomes

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 28

Description: 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 months

Secondary Outcomes

Description: 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 months

Description: DCR, proportion of patients with best overall response of CR, PR or SD

Measure: Disease Control Rate (DCR)

Time: up to approximately 36 months

Description: 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 months

Description: 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 months

Description: OS, defined as time from date of treatment to death due to any cause

Measure: Overall Survival (OS)

Time: up to approximately 60 months

Description: to assess the pharmacokinetic profile

Measure: Maximum observed plasma concentration (Cmax)

Time: Cycle 1 Day1 and Day 28

Description: to assess the pharmacokinetic profile

Measure: Time of maximum observed plasma concentration (Tmax)

Time: Cycle 1 Day1 and Day 28

Description: to assess the pharmacokinetic profile

Measure: Area under the plasma concentration time curve (AUC)

Time: Cycle 1 Day1 and Day 28

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

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 - 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 - c-Met GCN ≥ 6 or cluster amplification is required if participant is resistant to1st or 2nd generation EGFR-TKI ;c-MET GCN statue is not required, If participant is resistant to3rd generation EGFR-TKI (osimertinib); - 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 - 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 - c-Met GCN ≥ 6 or cluster amplification is required if participant is resistant to1st or 2nd generation EGFR-TKI ;c-MET GCN statue is not required, If participant is resistant to3rd generation EGFR-TKI (osimertinib); - 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 ---



HPO Nodes


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