Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative
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|ClinicalTrials.gov Identifier: NCT03758287|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: CT053PTSA Drug: Gefitinib||Phase 1 Phase 2|
This study is being carried out in two parts, part 1 and part 2.
Part 1: This is the dose-escalation part. The primary purpose of the part 1 portion is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the appropriate doses of CT053PTSA in combination with gefitinib for further studies.
Part 2: This is the expansion part. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 17, 2021|
|Estimated Study Completion Date :||November 17, 2021|
Experimental: CT053PTSA +Gefitinib
Patients will receive CT053PTSA and gefitinib over a 28-day cycle until progressive disease, intolerable toxicity or subject's withdrawal from treatment.
CT053PTSA will be administered daily, at a dose of 30 mg/40mg/60mg orally .
Gefitinib will be administered daily, at a dose of 250 mg orally .
Other Name: Ningetinib
Other Name: Iressa
- Part 1（dose-escalation part）: Maximum Tolerated Dose (MTD) [ Time Frame: Cycle 1 Day 1 to Cycle 1 Day 28 ]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
- Part 2（expansion part）: Overall Response Rate [ Time Frame: up to approximately 36 months ]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
- Number of patients with adverse events (AEs) as a measure of safety and tolerability [ Time Frame: up to approximately 36 months ]Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs
- Disease Control Rate (DCR) [ Time Frame: up to approximately 36 months ]DCR, proportion of patients with best overall response of CR, PR or SD
- Progression-free Survival (PFS) [ Time Frame: up to approximately 36 months ]PFS, defined as time from date of treatment to disease progression or death due to any cause
- Duration of Response (DOR) [ Time Frame: up to approximately 36 months ]DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause
- Overall Survival (OS) [ Time Frame: up to approximately 60 months ]OS, defined as time from date of treatment to death due to any cause
- Maximum observed plasma concentration (Cmax) [ Time Frame: Cycle 1 Day1 and Day 28 ]to assess the pharmacokinetic profile
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Cycle 1 Day1 and Day 28 ]to assess the pharmacokinetic profile
- Area under the plasma concentration time curve (AUC) [ Time Frame: Cycle 1 Day1 and Day 28 ]to assess the pharmacokinetic profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758287
|Contact: Li Zhang, MD||(086)firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Li Zhang, MD|
|Principal Investigator: Li Zhang, MD|
|Principal Investigator:||Li Zhang, MD||Sun Yat-sen University|