A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non… (NCT05668988) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
United States324 participantsStarted 2022-12-13
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged at least 18 years old (or per local regulatory/IRB requirement).
✓. 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.
✓. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
✓. At least 1 measurable lesion per RECIST Version 1.1
✓. Life expectancy ≥ 12 weeks
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
✓. Adequate organ and hematologic function
Exclusion criteria
✕. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
✕. Spinal cord compression or leptomeningeal metastasis.
What they're measuring
1
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
Timeframe: Up to approximately 34 months after the first participant is randomized
✕. History of stroke or intracranial hemorrhage within 6 months before randomization.
✕. 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).