Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change (NCT03191149) | Clinical Trial Compass
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
United States46 participantsStarted 2018-04-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Participants must have 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. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria
* An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay
* NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
* Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
* Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
* Participants must not have previously received osimertinib
* Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Hemoglobin \>= 9.0 g/L (within 4 weeks before registr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for lung cancers with an EGFR Exon 20 change — can you test my tumor to confirm whether I have this exact mutation, and does my specific type of Exon 20 change match what this trial is looking for?
2This is a Phase 2 trial measuring 'best objective response,' which means researchers are still learning how well osimertinib works for this particular mutation — given that, how does the potential benefit compare to standard treatments that are already approved for my situation?
3Osimertinib is already approved for other EGFR mutations in lung cancer, but this trial is testing it for Exon 20 changes specifically — does the existing safety data from those other uses give us a reasonable picture of the risks I might face if I were to join this study?
4My cancer is classified as advanced or recurrent non-small cell lung cancer — would joining this trial mean delaying or replacing any standard-of-care options that might be appropriate for my stage, and is that a trade-off worth discussing?
5Since this trial is still actively recruiting, how long would I realistically need to commit to treatment and follow-up visits, and are there logistical requirements like frequent testing or travel that I should factor into my decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.