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NCT05668988 · ClinicalTrials.gov registry record · Phase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Dizal Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 324
- Enrollment target
- 20
- Study locations
NCT05668988: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Dizal Pharmaceuticals.
NCT05668988 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Dizal Pharmaceuticals. The registered enrollment target is 324 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05668988, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Dizal Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 324 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG sunvozertinib
- DRUG Pemetrexed+carboplatin
Study Locations (20)
Other
- Centro de Educación Médica e Investigaciones Clínicas, CEMIC - Buenos Aires
- Centro Diabaid - Buenos Aires
- Centro Medico Austral - Buenos Aires
- Consultorios Medicos Dr. Doreski - Fundacion Respirar - Buenos Aires
- Fundacion Cenit Para El Estudio De Neurociencias - Buenos Aires
Florida
- D&H Cancer Research Center LLC - Margate
- BRCR Medical Center Inc. - Plantation
- H. Lee Moffitt Cancer Center - Tampa
Texas
- Texas Oncology - Baylor Charles A. Sammons Cancer Center - Dallas
- The University of Texas MD Anderson cancer center - Houston
- exas Oncology--McAllen - Weslaco
California
- OPN Healthcare, Inc. - Glendale
- Kaiser Permanente Medical Center - Vallejo
New York
- NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health - New York
- Columbia University Medical Center - New York
Ohio
- Gabrail Cancer Center Research - Canton
- OSU Brain & Spine Hospital - Columbus
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
Oregon
- Providence Portland Institute Franz - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 3 |
What the registry record for NCT05668988 still lists
NCT05668988 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which sunvozertinib is the first listed.
NCT05668988 names 20 study sites across 9 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05668988 about?
NCT05668988 is a clinical study titled "A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)". 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 th...
What is the current status of trial NCT05668988?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 324 participants. The study started on 2022-12-13. Estimated completion is 2027-10-31.
What conditions does trial NCT05668988 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05668988?
The interventions under investigation include: sunvozertinib (DRUG), Pemetrexed+carboplatin (DRUG).
Who is sponsoring clinical trial NCT05668988?
This trial is sponsored by Dizal Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05668988 being conducted?
This trial has 20 study locations across California, Colorado, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05668988's enrollment target sits among peer trials
324 113th of 454 higher than 342 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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