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

NCT06295432 | Recruiting Phase 2

• 1 other identifier: DZ2022E0001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  DLT: 21 days after the first dose; AE that began after the start of trial medication treatment until 28 days after last dose.

Study Arms (1)

DZD9008+AZD4205

EXPERIMENTAL

All subjects will receive both DZD9008 tablets and AZD4205 capsules orally. DZD9008 dosing will start at 200 mg daily, AZD4205 dosing will start at 75 mg daily.

Drug: DZD9008+AZD4205

Interventions

DZD9008+AZD4205 DRUG

Daily 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.

Also known as: Inapplicable

DZD9008+AZD4205

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Predicted life expectancy ≥ 12 weeks.
• Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable e.g. no evidence of progression for at least 2 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging (magnetic resonance image \[MRI\] or computed tomography \[CT\] scan) during the screening period), neurologically asymptomatic and not require corticosteroid treatment.
• Adequate organ system functions, as outlined below
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Absolute lymphocyte count ≥ 0.8 x 109/L
• Platelets ≥ 100 x 109/L
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver involvement or ≤ 5 x ULN with liver involvement
• Creatinine ≤ 1.5 x ULN, or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method
• International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;

You may not qualify if:

• Treatment with any of the followings:
• 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.
• Patients should avoid eating food known to be inhibitors of CYP3A such as grapefruit and Seville oranges (and other products containing these fruits, e.g., grapefruit juice or marmalade) within 2 weeks before the first administration of IP and 2 weeks after the therapy.
• Drugs that prolong the QT interval need to be discontinued before the start of IP
• Major surgery (excluding biopsy) within 4 weeks before the first administration of IP, or expect to have major surgery during study.
• Treatment with any investigational drug (or unable to stop using) within 4 weeks before the first administration of IP
• Spinal cord compression or leptomeningeal metastasis.
• Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer type which has been disease free for \> 2 years with life expectancy \>2 years
• Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting IP with the exception of alopecia.
• History of stroke or intracranial haemorrhage within 6 months before the first administration of IP.
• As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (e.g., hemophilia, Von Willebrand disease).
• Presence of persistent or active infection, including but not limited to:

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (4)

Guangdong Provincial People'S Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, China

COMPLETED

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

COMPLETED

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhen Wang

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xindi Wang

CONTACT

+ 86 21 6109 8456; xindi.wang@dizalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 6, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)