A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • DZD9008+AZD4205

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators