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Trial + Data / Events	Status	Ph	N	Region	Interventions	Sponsor	Conditions	Primary compl	Study compl
Pozenveo (poziotinib) / Assertio
NCT05045404: Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer	Withdrawn	2	36	NA	Poziotinib Hydrochloride, 1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE	M.D. Anderson Cancer Center	Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8	02/23	02/23
ZENITH20, NCT03318939 / 2018-001868-36: Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation FDA issued CRL regarding NDA for the treatment of previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations Nov 2022 - Nov 2022: FDA issued CRL regarding NDA for the treatment of previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations ODAC meeting for NSCLC Sep 2022 - Sep 2022: ODAC meeting for NSCLC Data from ZENITH20 trial for treatment-naïve and previously treated NSCLC at ESMO 2022 Sep 2022 - Sep 2022: Data from ZENITH20 trial for treatment-naïve and previously treated NSCLC at ESMO 2022 Presentation of data from of ZENITH20 trial in G778_P780dup HER2 Exon 20 Insertion Mutations NSCLC at ESMO 2022 Sep 2022 - Sep 2022: Presentation of data from of ZENITH20 trial in G778_P780dup HER2 Exon 20 Insertion Mutations NSCLC at ESMO 2022 Data from ZENITH20 trial for NSCLC at ESMO TAT virtual congress 2021 Mar 2021 - Mar 2021: Data from ZENITH20 trial for NSCLC at ESMO TAT virtual congress 2021 Data from cohort 3 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Dec 2020 - Dec 2020: Data from cohort 3 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Data from cohort 5 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Dec 2020 - Dec 2020: Data from cohort 5 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Data from cohort 2 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Jul 2020 - Jul 2020: Data from cohort 2 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC From ZENITH20 trial in EGFR exon 20 insertion mutated NSCLC at ASCO 2020 Jun 2020 - Jun 2020: From ZENITH20 trial in EGFR exon 20 insertion mutated NSCLC at ASCO 2020 For 2L NSCLC patients with EGFR exon 20 insertion mutations Dec 2019 - Dec 2019: For 2L NSCLC patients with EGFR exon 20 insertion mutations More	Terminated	2	648	Europe, Canada, US, RoW	Poziotinib	Spectrum Pharmaceuticals, Inc	NSCLC	04/23	04/23
NCT03744715 / 2020-005213-40: A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib	Terminated	2	7	US	Poziotinib	Spectrum Pharmaceuticals, Inc	NSCLC, Breast Cancer	03/23	03/23
NCI-2017-00831, NCT03066206: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC Updated data from P2 trial in NSCLC with exon 20 mutations at WCLC 2018 Sep 2018 - Sep 2018: Updated data from P2 trial in NSCLC with exon 20 mutations at WCLC 2018 In patients with EGFR exon 20 mutations Sep 2018 - Sep 2018: In patients with EGFR exon 20 mutations In patients with EGFR exon 20 mutations Apr 2018 - Apr 2018: In patients with EGFR exon 20 mutations Interim data presentation for NSCLC at World Lung Conference 2017 in Japan [screenshot] Oct 2017 - Oct 2017: Interim data presentation for NSCLC at World Lung Conference 2017 in Japan [screenshot] More	Active, not recruiting	2	93	US	Poziotinib, HM781-36B, NOV120101	M.D. Anderson Cancer Center, National Cancer Institute (NCI), Spectrum Pharmaceuticals, Inc	EGFR Exon 20 Mutation, ERBB2 Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7	12/25	12/25
NCT04402008: Study of Poziotinib in Japanese Patients With NSCLC	Terminated	1/2	42	Japan	Poziotinib Once Daily Dosing, Poziotinib Twice Daily Dosing, Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1	Spectrum Pharmaceuticals, Inc	NSCLC	02/23	02/23

Trial + Data / Events	Status	Ph	N	Region	Interventions	Sponsor	Conditions	Primary compl	Study compl
Pozenveo (poziotinib) / Assertio
NCT05045404: Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer	Withdrawn	2	36	NA	Poziotinib Hydrochloride, 1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE	M.D. Anderson Cancer Center	Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8	02/23	02/23
ZENITH20, NCT03318939 / 2018-001868-36: Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation FDA issued CRL regarding NDA for the treatment of previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations Nov 2022 - Nov 2022: FDA issued CRL regarding NDA for the treatment of previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations ODAC meeting for NSCLC Sep 2022 - Sep 2022: ODAC meeting for NSCLC Data from ZENITH20 trial for treatment-naïve and previously treated NSCLC at ESMO 2022 Sep 2022 - Sep 2022: Data from ZENITH20 trial for treatment-naïve and previously treated NSCLC at ESMO 2022 Presentation of data from of ZENITH20 trial in G778_P780dup HER2 Exon 20 Insertion Mutations NSCLC at ESMO 2022 Sep 2022 - Sep 2022: Presentation of data from of ZENITH20 trial in G778_P780dup HER2 Exon 20 Insertion Mutations NSCLC at ESMO 2022 Data from ZENITH20 trial for NSCLC at ESMO TAT virtual congress 2021 Mar 2021 - Mar 2021: Data from ZENITH20 trial for NSCLC at ESMO TAT virtual congress 2021 Data from cohort 3 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Dec 2020 - Dec 2020: Data from cohort 3 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Data from cohort 5 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Dec 2020 - Dec 2020: Data from cohort 5 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Data from cohort 2 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC Jul 2020 - Jul 2020: Data from cohort 2 of ZENITH20 trial for EGFR or HER2 exon 20 insertion mutation NSCLC From ZENITH20 trial in EGFR exon 20 insertion mutated NSCLC at ASCO 2020 Jun 2020 - Jun 2020: From ZENITH20 trial in EGFR exon 20 insertion mutated NSCLC at ASCO 2020 For 2L NSCLC patients with EGFR exon 20 insertion mutations Dec 2019 - Dec 2019: For 2L NSCLC patients with EGFR exon 20 insertion mutations More	Terminated	2	648	Europe, Canada, US, RoW	Poziotinib	Spectrum Pharmaceuticals, Inc	NSCLC	04/23	04/23
NCT03744715 / 2020-005213-40: A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib	Terminated	2	7	US	Poziotinib	Spectrum Pharmaceuticals, Inc	NSCLC, Breast Cancer	03/23	03/23
NCI-2017-00831, NCT03066206: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC Updated data from P2 trial in NSCLC with exon 20 mutations at WCLC 2018 Sep 2018 - Sep 2018: Updated data from P2 trial in NSCLC with exon 20 mutations at WCLC 2018 In patients with EGFR exon 20 mutations Sep 2018 - Sep 2018: In patients with EGFR exon 20 mutations In patients with EGFR exon 20 mutations Apr 2018 - Apr 2018: In patients with EGFR exon 20 mutations Interim data presentation for NSCLC at World Lung Conference 2017 in Japan [screenshot] Oct 2017 - Oct 2017: Interim data presentation for NSCLC at World Lung Conference 2017 in Japan [screenshot] More	Active, not recruiting	2	93	US	Poziotinib, HM781-36B, NOV120101	M.D. Anderson Cancer Center, National Cancer Institute (NCI), Spectrum Pharmaceuticals, Inc	EGFR Exon 20 Mutation, ERBB2 Gene Mutation, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7	12/25	12/25
NCT04402008: Study of Poziotinib in Japanese Patients With NSCLC	Terminated	1/2	42	Japan	Poziotinib Once Daily Dosing, Poziotinib Twice Daily Dosing, Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1	Spectrum Pharmaceuticals, Inc	NSCLC	02/23	02/23