DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)

Sponsor
Dizal Pharmaceuticals
Study ID
NCT06276283
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab.

Key Dates

First listed
Feb 23, 2024
Start date
Feb 15, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DZD9008 plus Bevacizumab
    This single-arm study includes two parts (dose escalation \[Part A\] and dose expansion \[Part B\]).

Primary Outcome Measure

Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs. [ Time Frame: The first treatment cycle (each cycle is 21 days) for DLT; From the first dose of study treatment to 28 days after the last dose of study treatment for TEAE; and from ICF signature to 28 days after the last dose of study treatment for SAE. ]

Central Contacts

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