Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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.

NCT05967689 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 220 participants
Start Date 2023-07-31
Est. Completion 2028-12-31
Phase Phase 2

Sponsor

Taiho Oncology

46 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05967689

The ClinicalTrials.gov registry entry for NCT05967689 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05967689 reports 20 study locations spanning 12 distinct geographic areas — top geographies include New York, New Jersey, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05967689?

The interventions under investigation include: TAS6417 (DRUG), CYP Cocktail (DRUG), Transporter Cocktail (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05967689?

This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial