RecruitingNot ApplicableNCT05559645

Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)

DZD9008 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutations: Cohort Study


Sponsor

Peking Union Medical College Hospital

Enrollment

180 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single center cohort study to access the anti-tumor efficacy, safety and tolerability of DZD9008 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations and EGFR uncommon mutations who have progressed following standard TKI therapy, and in treatment naive patients with NSCLC harboring EGFR Exon20 insertion mutation and EGFR sensitizing mutations.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called DZD9008 — a targeted pill that blocks a mutated protein called EGFR — in patients with advanced or metastatic non-small cell lung cancer that has specific EGFR mutations, including some rarer types like Exon 20 insertions. **You may be eligible if:** - You are 18 or older with confirmed advanced or metastatic non-small cell lung cancer - Your cancer has an EGFR mutation confirmed by a lab test - You are in good enough health (ECOG 0–1) - Your cancer has progressed on prior standard therapy (some early-stage cohorts may accept treatment-naive patients) - Stable brain metastases (not requiring steroids) are allowed **You may NOT be eligible if:** - Your cancer does not have an EGFR mutation - You have uncontrolled brain metastases requiring steroids - Your blood counts, liver, or kidney function are inadequate - You have had prior treatment with this specific class of EGFR inhibitor 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

DRUGDZD9008

Daily dosing of DZD9008 200mg

DRUGDZD9008

Daily dosing of DZD9008 300mg


Locations(1)

Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT05559645


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