Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

NCT03191149

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

Participants Needed

344

Research Sites

479 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have a confirmed diagnosis of non-small cell lung cancer (NSCLC)
Disease stage must be advanced (stage IV, stage IIIB not suitable for definitive therapy, or recurrent disease after stage I-III)
EGFR exon 20 insertion mutation must be detected by a certified tissue test
Measurable disease with baseline measurements within 4 weeks before registration
At least one prior line of therapy for advanced lung cancer received
No prior treatment with osimertinib
No therapies targeting PDL1, PD1, or CTLA4 within 6 months before registration
Age 18 years or older
ECOG performance status of 0 or 1
Hemoglobin level of 9.0 g/L or higher within 4 weeks before registration
White blood cell count of 3,000/mcL or higher within 4 weeks before registration
Absolute neutrophil count of 1,500/mcL or higher within 4 weeks before registration
Platelet count of 100,000/mcL or higher within 4 weeks before registration
Total bilirubin ≤ 1.5 times upper limit normal (ULN) or ≤ 3 times ULN with documented Gilbert's syndrome or liver metastases within 4 weeks before registration
AST and ALT ≤ 3 times ULN or ≤ 5 times ULN if liver metastases present within 4 weeks before registration
Creatinine ≤ 1.5 times ULN within 4 weeks before registration
No clinically active or symptomatic interstitial lung disease or pneumonitis
No radiation to lung fields within 4 weeks before starting treatment; specific timing rules apply for other radiation types
No symptomatic brain metastases, leptomeningeal disease, or spinal cord compression; stable corticosteroid use allowed if clinically asymptomatic
LVEF at or above institutional lower limit of normal (or ≥ 50%) by ECHO or nuclear study within 4 weeks before registration
No significant cardiac abnormalities or conditions affecting heart rhythm and QT interval
No second active cancer, except those treated and inactive
No other investigational agents currently used; prior investigational agent use requires washout
No uncontrolled illnesses that would limit compliance
No history of hypersensitivity to osimertinib or similar drugs
No use of potent CYP3A4 inducers within 3 weeks before starting treatment
No unresolved toxicities above grade 1 from prior therapy except alopecia or certain neuropathies
No refractory nausea, vomiting, or gastrointestinal conditions affecting drug absorption
Women must not be pregnant or breastfeeding; pregnancy tests required for women of childbearing potential
Use of effective contraception required for women of childbearing potential and sexually active males during and after treatment
No other anticancer or investigational agents during study treatment
Supportive care allowed as needed by investigator

You will not qualify if you...

Clinically active or symptomatic interstitial lung disease or pneumonitis affecting daily living or requiring treatment
Radiation to lung fields within 4 weeks before treatment or insufficient washout periods for other radiation types
Symptomatic brain metastases, leptomeningeal disease, or spinal cord compression
Left ventricular ejection fraction below institutional lower limit or under 50% if LLN undefined
Mean resting corrected QT interval ≥ 470 msec or history of QT prolongation requiring medication discontinuation
Use of medications known to cause Torsades de Pointes or significant ECG abnormalities
Symptomatic heart failure New York Heart Association grade II-IV
Second clinically active cancer not treated with curative intent or not inactive
Use of other investigational agents without proper washout
Uncontrolled intercurrent illnesses such as infections, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
History of hypersensitivity to osimertinib or similar drugs
Use of potent CYP3A4 inducers or certain herbal supplements like St John's wort
Unresolved toxicities greater than grade 1 from prior therapies, except alopecia or some neuropathies
Refractory nausea, vomiting, or gastrointestinal conditions preventing adequate drug absorption
Pregnant or breastfeeding women
Inability or unwillingness to use effective contraception as required

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Trial Site Locations

Total: 344 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Active, Not Recruiting

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Active, Not Recruiting

Alaska Breast Care and Surgery LLC