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- Check4 days agoChange DetectedThe study has expanded to 63 locations and has been updated to revision v2.10.0, replacing the previous revision v2.9.7.SummaryDifference0.3%
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- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
- Check25 days agoChange DetectedThe value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent change in the version of the content on the webpage.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the web page.SummaryDifference0.1%
- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus Genetics related topics: Lung cancer FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Interventional Model Description: Each treatment cycle is 28 calendar days in duration. There will be seven participant cohorts and eligible participants will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status and prior treatment status: Cohort 1: Previously treated participants with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 2: Previously treated participants with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 3: Treatment naïve participants with EGFR exon 20 insertion mutant positive NSCLC (fully enrolled) Cohort 4: Treatment naïve participants with HER2 exon 20 insertion mutant positive NSCLC Cohort 5: Participants who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed Cohort 6: Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib Cohort 7: Participants with EGFR or HER2 activating mutations Show less Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Poziotinib Cohort 1: Previously treated participants with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 2: Previously treated participants with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 3: Treatment naïve participants with EGFR exon 20 insertion-mutant positive NSCLC (fully enrolled) Cohort 4: Treatment naïve participants with HER2 exon 20 insertion mutant positive NSCLC Cohort 5: Participants who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed Cohort 6: Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib Cohort 7: Participants with EGFR or HER2 activating mutations Drug : Poziotinib The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. Cohorts 1-3: 16 mg QD Cohort 4: 8 mg BID Cohort 5: randomized to 8 mg BID or 6 mg BID or 10 mg QD Cohorts 6 and 7: 8 mg BIDSummaryDifference24%
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