This study is designed to evaluate safety and antitumor activity of DZD6008 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
DZD6008 was administered orally at 40/60/90 mg QD.
Pemetrexed 500 mg/m2, every 3 weeks, intravenous infusion.
Carboplatin AUC 5 mg/mL/min, every 3 weeks, intravenous infusion.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with Dose-limiting Toxicities (DLTs)
To assess safety and tolerability
Time frame: 21 days after the first dosing
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
To assess safety and tolerability
Time frame: Through the study completion, an average of around 1 year.
Objective Response Rate (ORR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To assess anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Duration of Response(DoR)
DoR is defined as the time from the date of the first documented response (subsequently confirmed) according to RECIST 1.1 to the date of objective disease progression or death, whichever occurred first.
Time frame: Through the study completion, an average of around 1 year.]
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects with response defined as complete response, partial response, and stable disease according to RECIST 1.1 by the investigator.
Time frame: Through the study completion, an average of around 1 year.
Progression Free survival (PFS)
PFS is defined as the time from the first dose of the subject to objective disease progression based on RECIST 1.1 or death due to any cause (whichever occurs first).
Time frame: Through the study completion, an average of around 1 year.
Maximum Plasma Concentration (Cmax) of DZD6008
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Docetaxel 75 mg/m2, every 3 weeks, intravenous infusion.
Cmax = Maximum concentration
Time frame: Plasma samples were collected at cycle 1, 2, 3, 5, 7, and 9, or cycle 1, 3, 5 and subsequent odd number cycles (cycle number adaptive to be consistent with tumor assessment), each cycle is 21 days
Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration (AUC0-t) of DZD6008
AUC0-t= Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration
Time frame: Plasma samples were collected at cycle 1, 2, 3, 5, 7, and 9, or cycle 1, 3, 5 and subsequent odd number cycles (cycle number adaptive to be consistent with tumor assessment), each cycle is 21 days
Maximum Plasma Concentration (Cmax) of docetaxel
Cmax = Maximum concentration
Time frame: Plasma samples were collected on at cycle 1 and 2, each cycle is 21 days
Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration (AUC0-t)of docetaxel
AUC0-t = Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration
Time frame: Plasma samples were collected at cycles 1 and 2, each cycle is 21 days