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EGFR Inhibitor

Oral EGFR Inhibitor for Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Avistone Biotechnology Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Male or female adult patients 18 years of age or older

Patients should have recovered from toxicities related to prior anti-tumor therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests a drug to see if it's safe and effective for people with advanced lung cancer. It includes two parts with different numbers of patients in each.

Who is the study for?

Adults over 18 with Non-Small Cell Lung Cancer (NSCLC) and a specific EGFR mutation can join. They should be recovered from previous cancer treatments, have at least one measurable tumor, not have other recent cancers or significant illnesses, and agree to use birth control. Pregnant women and those with certain lung conditions or recent radiotherapy are excluded.Check my eligibility

What is being tested?

The trial is testing PLB1004, an oral drug for NSCLC patients with a particular genetic change in their cancer cells. It's in Phase I where they're figuring out the right dose by starting small and increasing it across groups of patients before expanding to more people at the best doses found.See study design

What are the potential side effects?

While specific side effects of PLB1004 aren't listed here, similar drugs often cause reactions like skin issues, diarrhea, mouth sores, nail changes, dry skin or eyes. There might also be risks of liver problems or lung inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have recovered from side effects of my previous cancer treatments.

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I have recovered from any major surgery I've had.

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My cancer has a specific EGFR mutation.

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You are expected to live for at least 12 more weeks.

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You need to have at least one visible and measurable tumor according to specific guidelines.

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I am using effective birth control methods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Safety profile of PLB1004 per CTCAE v5.0

Secondary outcome measures

Area Under the Curve (AUC) of PLB1004

Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)

Disease Control Rate (DCR)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PLB1004Experimental Treatment1 Intervention

PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Avistone Biotechnology Co., Ltd.Lead Sponsor

6 Previous Clinical Trials

1,010 Total Patients Enrolled

Weizhe Xue, Ph.DStudy DirectorAvistone Biotechnology Co., Ltd.

Frequently Asked Questions

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

Has the FDA issued any clearance for PLB1004?

"Taking into account the Phase 1 trial status of PLB1004, our internal team ranks its safety as a score of 1. This is due to there being limited data which corroborates efficacy and safeguards against possible harm."

Answered by AI

Is there capacity for more patients to join this clinical trial?

"The clinicaltrials.gov database reveals that recruitment for this trial is finished; it was first posted on September 29th 2023 and last updated two weeks later. Despite recruiting having ceased, there are many other trials seeking participants at the present time — an impressive 2,094 in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

2023. "A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046495.