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

Description

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).

Conditions

Non-small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Glendale

WK28 Investigative Site, Glendale, California, United States, 91203

Vallejo

WK28 Investigative Site, Vallejo, California, United States, 94589

Aurora

WK28 Investigative Site, Aurora, Colorado, United States, 80045

Margate

WK28 Investigative Site, Margate, Florida, United States, 33063

Plantation

WK28 Investigative Site, Plantation, Florida, United States, 33322

Tampa

WK28 Investigative Site, Tampa, Florida, United States, 33612

New York

WK28 Investigative Site, New York, New York, United States, 10016

New York

WK28 Investigative Site, New York, New York, United States, 10032

New York

WK28 Investigative Site, New York, New York, United States, 11501

Canton

WK28 Investigative Site, Canton, Ohio, United States, 44718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Aged at least 18 years old (or per local regulatory/IRB requirement).
  • 2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
  • 3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
  • 4. At least 1 measurable lesion per RECIST Version 1.1
  • 5. Life expectancy ≥ 12 weeks
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • 7. Adequate organ and hematologic function
  • 1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
  • 2. Spinal cord compression or leptomeningeal metastasis.
  • 3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
  • 4. History of stroke or intracranial hemorrhage within 6 months before randomization.
  • 5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dizal Pharmaceuticals,

Caicun Zhou, PRINCIPAL_INVESTIGATOR, Shanghai Pulmonary Hospital, Shanghai, China

Study Record Dates

2027-10-31