OncoMatch/Clinical Trials/NCT04780568
Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
Is NCT04780568 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Osimertinib and Tegavivint for metastatic lung non-small cell carcinoma.
Treatment: Osimertinib · Tegavivint — This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Allowed: EGFR g719x
Allowed: EGFR l861q
Allowed: EGFR s768i
Allowed: EGFR t790m
Disease stage
Required: Stage IV, IVA, IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Prior treatment with an EGFR TKI in any setting
Lab requirements
Blood counts
Leukocytes >= 3,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin >= 90 g/L
Kidney function
Creatinine within 1.5 x ULN OR GFR >= 50 mL/min/1.73 m^2 (measured or calculated by Cockcroft and Gault equation) - confirmation of creatinine clearance is only required for patients with creatinine levels above institutional upper limit of normal
Liver function
Total bilirubin <= 1.5 x institutional ULN and up to 3 mg/dL for patients with Gilbert's; AST/ALT <= 2.5 x institutional ULN and <= 5 x institutional ULN for patients with liver metastases
Cardiac function
NYHA Functional Classification class 2B or better; Mean resting QTcF > 470 msec excluded; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG excluded; Any factors that increase risk of QTc prolongation or arrhythmic events excluded; LVEF < lower limit of normal excluded
Total bilirubin <= 1.5 x institutional upper limit normal (ULN) and up to 3 mg/dL for patients with Gilbert's; AST/ALT <= 2.5 x institutional ULN and <= 5 x institutional ULN for patients with liver metastases; Creatinine within 1.5 x ULN OR GFR >= 50 mL/min/1.73 m^2; Leukocytes >= 3,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin >= 90 g/L; NYHA Functional Classification class 2B or better; Mean resting QTcF > 470 msec excluded; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG excluded; Any factors that increase risk of QTc prolongation or arrhythmic events excluded; LVEF < lower limit of normal excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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