Actively Recruiting
Improvement of the Value of Orally Administered Cancer Drugs: Arm 1: Osimertinib for Advanced EGFR-positive NSCLC Patients: A Phase II Study
Led by National University Hospital, Singapore · Updated on 2025-09-25
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer is a leading cause of cancer cases and deaths worldwide. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), have changed how non-small cell lung cancer (NSCLC) with EGFR mutations is treated. First- and second-generation TKIs like gefitinib, erlotinib, and afatinib have improved outcomes, but many patients develop resistance due to common mutations like exon 19 deletions and L858R in exon 21. This research evaluates Osimertinib, a newer treatment option for advanced EGFR-positive NSCLC patients who have not received prior EGFR therapy. Participants in this study will receive Osimertinib at a dose of 80 mg every other day. The study will assess treatment effectiveness using criteria such as objective response rate, progression-free survival, duration of response, incidence of brain metastases, and overall survival. Safety will be monitored by recording adverse events, vital signs, ECG, blood tests, and physical exams. Researchers will also use ctDNA to track mutations and study pharmacokinetic and pharmacodynamic markers like EGFR inhibition duration. During the study, participants will undergo regular clinical assessments, imaging scans (CT or MRI), laboratory tests, and physical examinations. Adherence to the treatment and protocol will be monitored closely. The main safety outcome is evaluated using standard criteria for adverse events. Participants are expected to comply with scheduled visits and procedures, with total participation duration depending on individual treatment and follow-up requirements.
CONDITIONS
Brief Title
Osimertinib for Advanced EGFR-positive NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures
- Be at least 18 years old
- Have locally advanced or metastatic NSCLC not suitable for surgery or radiotherapy
- Have validated activating EGFR sensitising mutations with or without T790M resistance mutation and no prior EGFR TKI treatment
- Be EGFR treatment naive
- Have ECOG performance status of 0 or 1 with no decline in the last 2 weeks
- Have normal organ and bone marrow function within 28 days before study entry, including specific blood counts and liver/kidney function
- Have life expectancy of at least 12 weeks
- For females of childbearing age, use adequate contraception, not be breastfeeding, and have a negative pregnancy test
- Males should be willing to use barrier contraception
- Be willing to comply with the study protocol, including treatment and scheduled visits
- Have at least one measurable lesion suitable for accurate repeated measurement by CT or MRI
You will not qualify if you...
- Use of other EGFR-TKIs within 8 days or five half-lives before study entry, or chemotherapy/anticancer drugs within 14 days
- Previous treatment with immune checkpoint inhibitors
- Presence of second primary cancer except certain treated cancers with no disease for 5 years
- Radiotherapy to over 30% of bone marrow or wide field radiation within 4 weeks before entry
- Unresolved toxicities from prior therapies greater than CTCAE grade 1 except alopecia grade 2 and platinum-related neuropathy
- Unstable spinal cord compression or brain metastases unless asymptomatic and off steroids for at least 2 weeks
- Major surgery within 4 weeks before study treatment
- Use or inability to stop medications or supplements affecting CYP3A4 enzyme
- Severe or uncontrolled systemic diseases or active infections like hepatitis B, C, or HIV
- History or evidence of interstitial lung disease or radiation pneumonitis requiring steroids
- Certain cardiac conditions including prolonged QT interval or arrhythmia risks
- Severe nausea, vomiting, or gastrointestinal conditions preventing drug absorption
- Known hypersensitivity to Osimertinib or similar drugs
- Pregnant or breastfeeding females or those not using effective contraception
- Inability or unwillingness to comply with study procedures
- Previous allogeneic bone marrow transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing until study completion or discontinuation
Participants are observed while receiving Osimertinib 80mg every other day to evaluate safety, tolerability, and efficacy including assessments such as vital signs, physical exams, and mutation monitoring.
Regular visits for assessments and safety monitoring
Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
G
Goh Boon Cher
G
goh
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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