RecruitingNCT05037331

Osimertinib for Advanced EGFR-positive NSCLC Patients

Improvement of the Value of Orally Administered Cancer Drugs: Arm 1: Osimertinib for Advanced EGFR-positive NSCLC Patients: A Phase II Study


Sponsor

National University Hospital, Singapore

Enrollment

58 participants

Start Date

Jul 22, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Lung cancer is the leading cause of cancer incidence (11.6%) and mortality (18.4%) globally\[1\]. Development of targeted therapies in the context of precision medicine changed the way lung cancer was diagnosed and treated. Small molecule inhibitors, like tyrosine kinase inhibitors (TKIs), are now standard first-line therapy for EGFR-positive non-small cell lung cancer (NSCLC). First-generation EGFR-TKIs gefitinib and erlotinib bind competitively to the ATP-binding site of EGFR TK domain. This binding in second-generation TKI afatinib is irreversible. These drugs have improved better outcome compared to standard conventional chemotherapy In spite of this, more than half of the patients with an EGFR TKI treatment develop resistance. Deletion in exon 19 and single point substitution L858R in exon 21 accounting for 44% and 41% of all EGFR mutations, respectively are the most common mutations in EGFR gene which cause this resistance in the patients. Asia has the highest prevalence of EGFR mutations (38.4%), followed by America (24.4%) and Europe (14.1%). Median progression-free survival of EGFR mutated NSCLC patients under erlotinib or gefitinib has been around 12 months and 5-year survival was 15%


Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing osimertinib — a targeted oral medication — in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR. This drug works by blocking the signal that drives tumor growth in these cases. **You may be eligible if...** - You are 18 or older with advanced or metastatic NSCLC containing an EGFR mutation - You have never been treated with an EGFR-targeting drug before - You have at least one measurable tumor - You are in generally good health (ECOG performance status 0–1) - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - You have previously been treated with another EGFR-targeting drug or immune checkpoint inhibitor - You have serious heart problems (abnormal heart rhythm, prolonged QT interval) - You have active interstitial lung disease or radiation-induced lung inflammation - You have had a bone marrow transplant - You are taking strong drugs that interfere with how osimertinib is processed (CYP3A4 inhibitors or inducers) - 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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Locations(1)

National University Hospital

Singapore, Singapore

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NCT05037331


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