Testing PLB1004 for Non-Small Cell Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I, multicenter, open-label study evaluates the safety and pharmacokinetics of PLB1004, an oral EGFR inhibitor, in patients with non-small cell lung cancer (NSCLC) harboring various EGFR mutations. The study consists of two parts: a dose escalation phase with 7 cohorts to determine the optimal dosing and a dose expansion phase focusing on patients with specific EGFR exon 20 insertion mutations. Participants will be closely monitored for safety and treatment response as they receive the medication according to the study protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document;
2. Male or female adult patients 18 years of age or older;
3. Patients should have recovered from toxicities related to prior anti-tumor therapy;
4. Patients should have recovered from the effects of major surgery;
5. Have a documented EGFR mutation by a local test in tissue or plasma;
6. At least 12 weeks life expectancy;
7. Must have at least one measurable lesion per RECIST v 1.1;
8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.

Exclusion Criteria:

1. Received radiotherapy within 14 days before enrollment;
2. Have significant or uncontrolled systemic disease;
3. Have significant or uncontrolled cardiovascular disease;
4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;
5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;
6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;
7. Pregnant or lactating women;
8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
9. Have any condition or illness that could affect the compliance with the protocol.

Where it's running

• University of California-Davis
  Sacramento, California, United States Recruiting
• Research Site
  Louisville, Kentucky, United States Recruiting
• Nebraska Cancer Specialists
  Omaha, Nebraska, United States Recruiting
• Research Site
  New York, New York, United States Recruiting
• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting
• Swedish Health Sciences
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Avistone Clinical Study Information Center Center
• Email: information.center@avistonebio.com
• Phone: +86-10-84148921

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.