Actively Recruiting
Osimertinib for Advanced EGFR-positive NSCLC Patients
Led by National University Hospital, Singapore · Updated on 2025-09-25
58
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%
CONDITIONS
Official Title
Osimertinib for Advanced EGFR-positive NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before any study procedures
- Aged 18 years or older
- Have locally advanced or metastatic NSCLC not suitable for surgery or radiotherapy
- Have validated activating EGFR sensitizing mutations with or without T790M resistance mutation and no prior EGFR TKI treatment
- Are EGFR treatment naive
- ECOG performance status of 0-1 without deterioration in the 2 weeks before enrollment
- Normal organ and bone marrow function based on recent lab tests
- Have a life expectancy of at least 12 weeks
- Females of childbearing potential must use effective contraception, not be breastfeeding, and have a negative pregnancy test before treatment
- Male patients willing to use barrier contraception
- Willing to follow study protocol, including treatments, visits, and examinations
- Have at least one measurable lesion not previously irradiated suitable for repeated measurement
You will not qualify if you...
- Treatment with other EGFR-TKIs within 8 days or five half-lives before study entry, or chemotherapy/anticancer drugs within 14 days
- Prior treatment with immune checkpoint inhibitors
- Having a second primary cancer except certain treated cancers with no evidence of disease for 5 or more years
- Radiotherapy to more than 30% of bone marrow or wide-field radiation within 4 weeks prior to study entry
- Unresolved toxicities greater than grade 1 from prior therapy, except specified exceptions
- Unstable spinal cord compression or brain metastases unless asymptomatic and off steroids for 2 weeks
- Major surgery within 4 weeks before study treatment without full recovery
- Use or inability to stop medications or supplements that affect CYP3A4 enzyme
- Severe or uncontrolled systemic diseases including infections like hepatitis B, C, or HIV
- History or evidence of interstitial lung disease or radiation pneumonitis requiring steroids
- Certain cardiac abnormalities or conditions increasing risk of QT prolongation
- Severe nausea, vomiting, gastrointestinal disease, or conditions preventing drug absorption
- Hypersensitivity to Osimertinib or related drugs
- Not using effective contraception or pregnant/breastfeeding females
- Unlikely to comply with study procedures
- Previous allogeneic bone marrow transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
G
Goh Boon Cher
CONTACT
G
goh
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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