NCT05037331

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 58 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: —

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%

Detailed description

To evaluate the efficacy (Objective Response Rate), safety and tolerability of 80mg Osimertinib eod dosing in NSCLC patients with sensitizing EGFR mutations and/or EGFR T790M resistance mutation that have no prior EGFR treatment. To investigate the efficacy and safety of Osimertinib 80mg/eod. Parameters like PFS, DoR, the incidence of brain metastases and OS will be assessed for the efficacy using RECIST criteria version 1.1. PFS in the brain will be another endpoint. Adverse events will be graded according to CTCAE v4.0 by recording vital signs, physical examinations, weight, ECG, ECOG performance status, clinical chemistry, haematology, urinalysis. We would use ctDNA to detect the mutations and compare the progress of the disease or the outcome of patients besides clinical assessments. The relationship between PK and selected efficacy, pharmacodynamic markers (like duration of inhibition of EGFR by hair follicle sampling) and safety endpoints will be assessed as well.

Conditions

• EGFR Positive Non-small Cell Lung Cancer
• Non Small Cell Lung Cancer

Timeline

• Start date: 2021-07-22
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-09-08
• Last updated: 2025-09-25

Locations

1 site across 1 country: Singapore