NCT05037331
Osimertinib for Advanced EGFR-positive NSCLC Patients
Recruiting · Not specified · National University Hospital, Singapore · registry updated 2025-09-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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%)....
Inclusion
- For inclusion in the study subjects should fulfil the following criteria:
- Provision of informed consent prior to any study-specific procedure
- Patients must be ≥ 18 years old
- Locally advanced /metastatic NSCLC not responsive to surgery or radiotherapy
- Validated activating EGFR sensitising mutations with or without T790M resistance mutation at the time of recruitment for patients who have no prior EGFR TKI treatment.
- Patients must be EGFR treatment naïve.
Exclusion
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Treatment with other EGFR-TKI within 8 days or within five half-lives of the compound before study entry whichever is the longer; any cytotoxic chemotherapy, or other anticancer drugs against NSCLC within 14 days of study entry
- Previously treated with an immune checkpoint inhibitor
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
- Radiotherapy to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks before the study entry
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of study treatment with the exception of alopecia grade 2 and platinum-related neuropathy.