Life sciences · Phase 3 Trial
ClinicalTrials.gov · November 3, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
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.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05973773). This is a study registration, not published results. Lead sponsor: Taiho Oncology, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 285 participants (ACTUAL). Conditions: Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation. Interventions: DRUG: TAS6417. Primary outcome measures: Part A and B: The rate and severity of treatment emergent AEs , approximately 5 years; Part A and Part B: Progression-free survival (PFS) by blinded independent central review (BICR) , approximately 5 years; Part A: The rate and severity of DLTs according to the NCI-Common Terminology Criteria of Adverse Events (CTCAE) v5.0 during Cycle 1 , approximately 5 years. Brief summary: The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.