OncoMatch/Clinical Trials/NCT03191149
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Is NCT03191149 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Osimertinib for advanced lung non-small cell carcinoma.
Treatment: Osimertinib — This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib 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 20 insertion
Disease stage
Required: Stage IV, IIIB (AJCC/IASLC 7th edition)
advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any prior therapy — advanced lung cancer
Patients must have previously received at least one line of therapy for their advanced lung cancer
Cannot have received: EGFR tyrosine kinase inhibitor (osimertinib)
Participants must not have previously received osimertinib
Cannot have received: anti-PD-L1 therapy
Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
Cannot have received: anti-PD-1 therapy
Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
Cannot have received: anti-CTLA-4 therapy
Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
Lab requirements
Blood counts
Hemoglobin >= 9.0 g/L; Leukocytes >= 3,000/mcL; ANC >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine <= 1.5 x ULN
Liver function
Total bilirubin <= 1.5 x ULN if no liver metastases or <= 3 x ULN in presence of Gilbert's syndrome or liver metastases; AST/ALT <= 3 x ULN; AST/ALT <= 5 x ULN with hepatic metastases
Cardiac function
ECHO or nuclear study within 4 weeks prior to registration; LVEF >= institutional LLN or >= 50% if LLN not defined; QTc < 470 msec from 3 ECGs; no history of QT prolongation requiring discontinuation; no concomitant medications known to cause Torsades de Pointes; no clinically important ECG abnormalities; no symptomatic heart failure (NYHA grade II-IV)
Hemoglobin >= 9.0 g/L (within 4 weeks before registration); Leukocytes/white blood cells >= 3,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Total bilirubin <= 1.5 x ULN if no liver metastases or <= 3 x ULN in presence of Gilbert's syndrome or liver metastases; AST/ALT <= 3 x ULN; AST/ALT <= 5 x ULN with hepatic metastases; Creatinine <= 1.5 x ULN; ECHO or nuclear study within 4 weeks prior to registration; LVEF >= institutional LLN or >= 50% if LLN not defined; QTc < 470 msec from 3 ECGs; no history of QT prolongation requiring discontinuation; no concomitant medications known to cause Torsades de Pointes; no clinically important ECG abnormalities; no symptomatic heart failure (NYHA grade II-IV)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
- Alaska Women's Cancer Care · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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