ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2022-12-13
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05668988

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged at least 18 years old (or per local regulatory/IRB requirement).
  2. 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. 3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
  4. 4. At least 1 measurable lesion per RECIST Version 1.1
  5. 5. Life expectancy ≥ 12 weeks
  6. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  7. 7. Adequate organ and hematologic function
  1. 1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
  2. 2. Spinal cord compression or leptomeningeal metastasis.
  3. 3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
  4. 4. History of stroke or intracranial hemorrhage within 6 months before randomization.
  5. 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).

Contacts and Locations

Principal Investigator

Caicun Zhou
PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China

Study Locations (Sites)

OPN Healthcare, Inc.
Glendale, California, 91203
United States
Kaiser Permanente Medical Center
Vallejo, California, 94589
United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
United States
D&H Cancer Research Center
Margate, Florida, 33054
United States
Brcr Global
Plantation, Florida, 33324
United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
United States
NYU Laura & Issac Perlmutter Cancer Center
New York, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10032
United States
Gabrail Cancer Center Research
Canton, Ohio, 44718
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
MD Anderson cancer center
Houston, Texas, 77030
United States
USOR - Texas Oncology--Weslaco
Weslaco, Texas, 78596
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Dizal Pharmaceuticals

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2027-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer