DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy.
Patients must be able to understand the nature of the trial and provide a signed and dated informed consent form prior to screening.
Aged at least 18 years old when sign ICF.
Histological or cytological confirmed locally advanced or metastatic NSCLC.
Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the previous 2 weeks.
Prior treatment with any onco-immunotherapy (e.g. PD-1) within 4 weeks before the first administration of IP.
Any cytotoxic chemotherapy, or other anticancer drugs from a previous treatment regimen within 2 weeks before the first administration of IP.
Radiotherapy within 2 weeks of the first dose or have not recovered from radiotherapy-related toxicity May receive palliative radiotherapy other than chest and brain, stereotactic radiosurgery and stereotactic body radiation therapy within 1 week prior to first dose a limited field of radiation for palliation within 1 week of the first administration of IP.
Patients currently receiving (or unable to stop using) medications known to be potent inhibitors or inducers of CYP3A or herbal supplements within 2 weeks before the first administration of IP.
Single group
DZD9008+AZD4205
DrugDaily dose of DZD9008+AZD4205 until intolerant, disease progression or patient decision. Starting dose of DZD9008 is 200mg once daily and starting dose of AZD4205 is 75mg once daily orally used. If tolerated, subsequent cohorts will evaluate increasing doses of the combination therapy.
Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs.
Part A: safety and tolerability of the combination therapy: incidence of DLT as defined in the protocol, incidence of ≥grade 3 TEAE as assessed by CTCAE, incidence of SAE; Part B: safety and tolerability of the combination therapy, to define RP2CD: incidence of ≥grade 3 TEAE as assessed by CTCAE, incidence of SAE.
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