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.
Signed informed consent.
Age ≥18 years old.
Locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment.
Documentation of EGFR sensitizing mutation confirmed by local laboratory.
Histology mixed with small cell lung cancer (SCLC) or with SCLC transformation.
Received immunotherapy or other antibody treatments (including EGFR-targeted antibodies, bispecific antibodies or antibody-drug conjugates, etc.) within 4 weeks before the first study drug administration.
Received any cytotoxic chemotherapy, study drugs or other anti-cancer drugs (excluding macromolecule drugs) within 14 days before the first study drug administration.
Received limited-range radiotherapy to relieve the disease within 7 days before the first study drug administration, or received more than 30% of the bone marrow radiotherapy or received wide-range radiotherapy within 28 days before the first medication.
Sequential
DZD6008
DrugDZD6008 was administered orally at 40/60/90 mg QD.
Pemetrexed
DrugPemetrexed 500 mg/m2, every 3 weeks, intravenous infusion.
Carboplatin
DrugCarboplatin AUC 5 mg/mL/min, every 3 weeks, intravenous infusion.
Docetaxel
DrugDocetaxel 75 mg/m2, every 3 weeks, intravenous infusion.
Number of participants with Dose-limiting Toxicities (DLTs)
To assess safety and tolerability
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
To assess safety and tolerability
Objective Response Rate (ORR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To assess anti-tumor activity
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.
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.
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).
Maximum Plasma Concentration (Cmax) of DZD6008
Cmax = Maximum concentration
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