A Phase II, Multicenter Study to Assess the Safety, Tolerability and Anti-tumor Efficacy of DZD9008 in Combination With AZD4205 in Standard Treatment Failed Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Mutations

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

⁃ Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN

• Male subjects with a female partner who intend to have children should use barrier contraception (e.g. condom) during their participation in the clinical study until 6 months after the last dose. Male subjects should not donate sperm during the clinical study until 6 months after the last dose. If the male subject has fertility requirements, it is recommended that sperm be frozen prior to the start of the clinical study.

• Female subjects should use contraception at screening until 6 weeks after the last dose of DZD9008 or 3 months after the last dose of AZD4205, whichever is later, should not be breastfeeding and should have a negative pregnancy test (blood or urine β-HCG) at the time of screening.

∙ Part A specific inclusion criteria:

• Subjects should harbour any type of EGFR mutation.

• Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic/locally advanced disease.

∙ Part B specific inclusion criteria:

• Subjects must have documented EGFR sensitizing mutation from a local certified laboratory.

• Subjects should have progressed on, or be intolerant of prior standard systemic therapy for metastatic/locally advanced disease.

• Patient must have measurable disease according to RECIST 1.1: At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for repeated measurement.

• Agree and be willing to provide an adequate amount of the required tumor tissue for exploratory studies.

Locations
Other Locations
China
Guangdong Provincial People'S Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Xindi Wang
xindi.wang@dizalpharma.com
+ 86 21 6109 8456
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 90
Treatments
Experimental: DZD9008+AZD4205
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.
Sponsors
Leads: Dizal Pharmaceuticals

This content was sourced from clinicaltrials.gov

Similar Clinical Trials