Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 29, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05668988). This is a study registration, not published results. Lead sponsor: Dizal Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 324 participants (ACTUAL). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: sunvozertinib; DRUG: Pemetrexed+carboplatin. Primary outcome measures: Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 , Up to approximately 34 months after the first participant is randomized. 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).