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NCT05967689 · ClinicalTrials.gov registry record · Phase 2
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
A Phase 2 study of Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations, sponsored by Taiho Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT05967689: Recruiting Phase 2 study of Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations, sponsored by Taiho Oncology.
NCT05967689 is a Phase 2 study of Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations that is actively recruiting participants, run by Taiho Oncology. The registered enrollment target is 220 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05967689, a Phase 2 study of Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations, is actively recruiting participants, sponsored by Taiho Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.
Conditions Studied
Interventions
- DRUG TAS6417
- DRUG CYP Cocktail
- DRUG Transporter Cocktail
Study Locations (20)
New York
- Memorial Sloan Kettering Cancer Center - Commack - Commack
- Memorial Sloan Kettering Cancer Center - Westchester - Harrison
- MSK Cancer Center - Long Island City
- Memorial Sloan Kettering Cancer Center - Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Cancer Center - Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Cancer Center - Monmouth - Middletown
- Memorial Sloan Kettering Cancer Center - Bergen - Montvale
Ohio
- Gabrail Cancer and Research Center - Canton
- Zangmeister Cancer Center - Columbus
- The Toledo Clinic Cancer Center - Toledo
New South Wales
- Bankstown-Lidcombe Hospital - Bankstown
- Genesis Care North Shore - Saint Leonards
Alabama
- University of Alabama at Birmingham - Birmingham
California
- City of Hope - Duarte - Duarte
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Nevada
- Comprehensive Cancer Centers of Nevada - Central Valley - Twain - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2023-07-31 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT05967689 shows while recruiting
NCT05967689 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher).
The record links to 1 condition, with Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations appearing as the primary indexed condition, and to 3 interventions - of which TAS6417 is the first listed.
NCT05967689 names 20 study sites across 12 states, led by New York, New Jersey, Ohio.
Frequently Asked Questions
What is clinical trial NCT05967689 about?
NCT05967689 is a clinical study titled "A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.". The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.
What is the current status of trial NCT05967689?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2023-07-31. Estimated completion is 2028-12-31.
What conditions does trial NCT05967689 study?
This clinical trial studies the following conditions: Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations.
What interventions are being tested in trial NCT05967689?
The interventions under investigation include: TAS6417 (DRUG), CYP Cocktail (DRUG), Transporter Cocktail (DRUG).
Who is sponsoring clinical trial NCT05967689?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05967689 being conducted?
This trial has 20 study locations across Alabama, California, Massachusetts, Nevada, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05967689's enrollment target sits among peer trials
220 275th of 2000 higher than 1,718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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