RecruitingPhase 2NCT06015503

A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

A Phase Ⅱ,Open-label, Single-line, Multiple Cohorts, Multicenter Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)


Sponsor

Avistone Biotechnology Co., Ltd.

Enrollment

157 participants

Start Date

Jul 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental drug called PLB1004 for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific and uncommon EGFR mutation called exon 20 insertion. This mutation is harder to treat than the more common EGFR mutations. **You may be eligible if...** - You are 18 or older - You have confirmed locally advanced or metastatic NSCLC (stage IIIB–IV) - Your tumor has the EGFR exon 20 insertion mutation - You have received prior platinum-based or immunotherapy-containing treatment (up to 3 prior lines) - You are in good health (ECOG 0–1) with a life expectancy of at least 12 weeks - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You received anti-cancer antibodies, chemotherapy, or herbal anti-cancer medicines too recently before starting the study - You had major surgery in the past 4 weeks - You received lung or whole-brain radiation within the past 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPLB1004

PLB1004 is a capsule in the form of 80mg and 40mg.


Locations(1)

Guangdong General Hospital

Guangzhou, Guangdong, China

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NCT06015503


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