OncRef

Clinical Trial: NCT05668988

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Dizal Pharmaceuticals
Information Provided By:Dizal Pharmaceuticals
Last Update Posted:2026-05-26

Study Overview

Brief Summary

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage.

Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Official Title

A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Drug: sunvozertinib
  • Drug: Pemetrexed+carboplatin

Other Study ID Numbers

  • DZ2022E0005

Start Date (Actual)

2022-12-13

Primary Completion Date (Actual)

2026-01-16

Study Completion Date (Estimated)

2027-10-31

Enrollment (Actual)

324

Study Type

Interventional

Phase

Phase 3