Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Muta… (NCT03318939) | Clinical Trial Compass
TerminatedPhase 2
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Stopped: Strategic business decision (unrelated to safety)
United States, Belgium, Canada648 participantsStarted 2017-10-11
Plain-language summary
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).
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.
Key Inclusion Criteria:
* Participant must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
* Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
* Prior treatment status:
* Cohorts 1 and 2: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
* Cohorts 3 and 4: Participant is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry.
* Cohort 5: Participants who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed
* Cohort 6: Participant with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
* Cohort 7: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
* Specific mutations:
* Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
* Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
* Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
* Cohort 6: Documented acquired EGFR mutation (…
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 was terminated before completing — do you know why it was stopped, and does that affect how seriously we should consider poziotinib as an option for my EGFR or HER2 exon 20 insertion mutation?
2Since this was a Phase 2 trial measuring objective response rate, what do the results actually show about how often tumors shrank with poziotinib, and is that data available for us to review together?
3Are there other trials or approved treatments specifically targeting EGFR or HER2 exon 20 insertions — like amivantamab or mobocertinib — that might be worth comparing to what this terminated trial found?
4Given that this trial is no longer enrolling, is poziotinib still accessible to me through any other means, such as compassionate use, expanded access, or a different ongoing study?
5How does my specific exon 20 insertion variant compare to the mutation profiles that were being studied in this trial, and does that affect whether poziotinib would even be a relevant option to discuss for my case?
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.