OncoMatch/Clinical Trials/NCT03586453
Osimertinib In EGFR Mutant Lung Cancer
Is NCT03586453 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Osimertinib for carcinoma, non-small-cell lung.
Treatment: Osimertinib — This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The names of the study drug involved in this study is: \- Osimertinib (Tagrisso)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Excluded: EGFR t790m
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Exception: except for subjects receiving first line osimertinib during the first three months of therapy
Prior or ongoing treatment with any of the following: EGFR targeted therapy (TKI or antibody) or any other targeted therapies targeting the ERBB family except for subjects receiving first line osimertinib during the first three months of therapy.
Cannot have received: EGFR-targeted antibody
Exception: except for subjects receiving first line osimertinib during the first three months of therapy
EGFR targeted therapy (TKI or antibody) or any other targeted therapies targeting the ERBB family except for subjects receiving first line osimertinib during the first three months of therapy.
Cannot have received: ERBB family targeted therapy
Exception: except for subjects receiving first line osimertinib during the first three months of therapy
any other targeted therapies targeting the ERBB family except for subjects receiving first line osimertinib during the first three months of therapy.
Cannot have received: cytotoxic chemotherapy
Exception: Patients who have completed adjuvant or neo-adjuvant chemotherapy > 6 months ago are considered treatment naïve
Any cytotoxic chemotherapy, investigational agents, immunotherapy or anticancer drugs for the treatment of metastatic NSCLC
Cannot have received: immunotherapy
Any cytotoxic chemotherapy, investigational agents, immunotherapy or anticancer drugs for the treatment of metastatic NSCLC
Cannot have received: anticancer drugs
Any cytotoxic chemotherapy, investigational agents, immunotherapy or anticancer drugs for the treatment of metastatic NSCLC
Cannot have received: investigational agent
Any cytotoxic chemotherapy, investigational agents, immunotherapy or anticancer drugs for the treatment of metastatic NSCLC
Lab requirements
Blood counts
absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL; hemoglobin >9.0 g/dL
Kidney function
creatinine ≤ 1.5 x ULN OR creatinine clearance ≥50 mL/min (Cockcroft-Gault)
Liver function
total bilirubin < 1.5x ULN if no liver metastases or < 3x ULN in presence of Gilbert's syndrome or liver metastases; AST(SGOT)/ALT(SGPT) <2.5x ULN or <5x ULN with liver metastases
Cardiac function
cardiac ejection fraction of < 45% excluded; no heart disease including congestive heart failure (NYHA Grade II or greater); unstable angina; prior myocardial infarction (NSTEMI or STEMI) within 6 months; hypertension with SBP >150 mm Hg or DBP >100 mm Hg while on antihypertensive medication; no clinically important ECG abnormalities; QTcF ≤ 450 ms in males or ≤ 470 ms in females
Participants must have normal organ and marrow function as defined below: absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL; hemoglobin >9.0 g/dL; total bilirubin < 1.5x ULN if no liver metastases or < 3x ULN in presence of Gilbert's syndrome or liver metastases; AST(SGOT)/ALT(SGPT) <2.5x ULN or <5x ULN with liver metastases; creatinine ≤ 1.5 x ULN OR creatinine clearance ≥50 mL/min (Cockcroft-Gault). Cardiac ejection fraction of < 45% excluded; see protocol for additional cardiac criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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