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EGFR Inhibitor

TAS3351 for Non-Small Cell Lung Cancer (TAS3351 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Locally advanced, non-resectable or metastatic NSCLC

Must have tumor tissue available to allow for analysis of EGFRmt status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated 3 years

Awards & highlights

TAS3351 Trial Summary

This trial is testing if a drug can safely and effectively treat advanced lung cancer with an EGFR mutation. #lungcancer #clinicaltrial #cancerresearch

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have a specific mutation called C797S in the EGFR gene. Participants must be able to perform daily activities with little to no assistance (ECOG performance status of 0 or 1), have tumor tissue available for analysis, and their major organs must function well. They should not be part of other conflicting studies, have unstable brain metastases, unresolved effects from past cancer treatments, significant heart issues, or conditions preventing pill ingestion.Check my eligibility

What is being tested?

The study is testing TAS3351's safety and effectiveness when taken orally by patients with NSCLC that has an acquired C797S EGFR mutation. It's a first-in-human study divided into phases: initial dose escalation to find the right dosage followed by expansion and phase II trials focusing on those who meet specific genetic criteria.See study design

What are the potential side effects?

While the exact side effects of TAS3351 are being studied since this is its first trial in humans, potential risks may include typical reactions to oral cancer medications such as nausea, diarrhea, fatigue, liver toxicity, skin rash and possible allergic reactions.

TAS3351 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer cannot be removed by surgery and has spread.

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My tumor tissue is available for EGFR mutation testing.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has specific EGFR mutations.

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My cancer has any type of EGFR mutation.

TAS3351 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351

Dose Expansion: To explore the efficacy of TAS3351

Phase 2: To assess the efficacy of TAS3351

Secondary outcome measures

Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351

Dose Escalation: To evaluate the antitumor activity of TAS3351

Dose Escalation:To evaluate the antitumor activity of TAS3351

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TAS3351 Trial Design

3Treatment groups

Experimental Treatment

Group I: TAS3351 Part C (Phase 2)Experimental Treatment1 Intervention

To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.

Group II: TAS3351 Part B (Dose Expansion)Experimental Treatment1 Intervention

TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.

Group III: TAS3351 Part A (Dose Escalation)Experimental Treatment1 Intervention

Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

11,384 Total Patients Enrolled

Media Library

TAS3351 (EGFR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05765734 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: TAS3351 Part B (Dose Expansion), TAS3351 Part C (Phase 2), TAS3351 Part A (Dose Escalation)

Non-Small Cell Lung Cancer Clinical Trial 2023: TAS3351 Highlights & Side Effects. Trial Name: NCT05765734 — Phase 1 & 2

TAS3351 (EGFR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05765734 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the chief goals of this medical experiment?

"This medical experiment will measure its primary outcome of assessing TAS3351's efficacy over a period of three years. Secondary objectives include characterizing the pharmacokinetics (PK) through Area under the plasma concentration-time curve (AUC), further exploring anti-tumor efficacy with Overall survival (OS), and additionally evaluating TAS3351's efficacy through OS measurements."

Answered by AI

To what extent is this trial being administered in various locations?

"The University of Texas M. D. Anderson Cancer Center in Houston, TX is one recruitment site for this trial along with Institut Gustave Roussy in Villejuif cedex, Val De Marne and Universitaetsklinikum Koeln in Koeln, Nordrhein Westfalen as well as 11 other centres across the globe."

Answered by AI

Are there any openings for new participants in this research endeavor?

"The clinical trial is currently in the recruitment phase, having been first posted on May 3rd 2023 and last updated June 12th of that same year."

Answered by AI

What is the current number of participants in this research project?

"Affirmative. Per the information on clinicaltrials.gov, this scientific experiment is currently recruiting participants and was first posted on May 3rd 2023 with its last update occurring on June 12th 2023. A total of 200 volunteers are sought from 11 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAS3351 in NSCLC Patients With EGFRmt

2023. "A Study of TAS3351 in NSCLC Patients With EGFRmt". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05765734.