OncoMatch/Clinical Trials/NCT03191149
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Is NCT03191149 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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 →Frequently asked questions
Is NCT03191149 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR tyrosine kinase inhibitor, anti-PD-L1 therapy, anti-PD-1 therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify