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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 belowSelect...
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
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
+5 moreTAS3351 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.
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Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,344 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer cannot be removed by surgery and has spread.You need to have a way for the doctors to measure your disease.I have a serious heart condition.My organs are working well.I cannot swallow or digest pills.My tumor tissue is available for EGFR mutation testing.I am still experiencing side effects from my previous cancer treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastases causing symptoms and instability.My cancer has specific EGFR mutations.My cancer has any type of EGFR mutation.
Research Study Groups:
This trial has the following groups:- Group 1: TAS3351 Part B (Dose Expansion)
- Group 2: TAS3351 Part C (Phase 2)
- Group 3: TAS3351 Part A (Dose Escalation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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