This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
DZD6008 will be administered orally at 40/60 mg QD or selected dose.
Sunvozertinib will be administered orally at 100 mg QD or selected dose.
Osimertinib will be administered orally at 80 mg QD
Beijing Chest Hospital
Beijing, Beijing Municipality, China
RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGZhejiang Taizhou Hospital
Taizhou, Zhejiang, China
RECRUITINGPart A: To assess safety and tolerability
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
Time frame: Through the study completion, an average of around 2 years
Part A: To assess safety and tolerability
Number of participants with Dose-limiting Toxicities (DLTs)
Time frame: 21 days after the first dose
Part B: To assess anti-tumor activity
Objective Response Rate (ORR) assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
ORR assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Duration of Response (DoR) assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Disease Control Rate (DCR) assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Percentage change in tumor size assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Progression Free Survival (PFS) assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part A: To characterize the Pharmacokinetics of DZD6008
To characterize the concentration of DZD6008 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Time frame: Through the study until the time specified in the protocol, an average of around half year.
Part A: To characterize the Pharmacokinetics of sunvozertinib and DZ0753
To characterize the concentrations of sunvozertinib and DZ0753 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Time frame: Through the study until the time specified in the protocol, an average of around half year.
Part B: To assess the anti-tumor activity
DoR assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
DCR assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
Percentage change in tumor size assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
PFS assessed by investigator per RECIST version 1.1
Time frame: Through the study completion, an average of around 2 years
Part B: To assess safety and tolerability
Number of participants with AEs /SAEs
Time frame: Through the study completion, an average of around 2 years
Part B: To characterize the Pharmacokinetics of DZD6008
To characterize the concentration of DZD6008 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Time frame: Through the study until the time specified in the protocol, an average of around half year.
Part B: To characterize the Pharmacokinetics of sunvozertinib and DZ0753
To characterize the concentration of sunvozertinib and DZ0753 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Time frame: Through the study until the time specified in the protocol, an average of around half year.
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