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    DRUG CLASS:

    HER4 inhibitor

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    Trial of Pre-operative Neratinib and Endocrine Therapy with Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers (NCT04886531)
    Phase 2
    Ruth O'Regan
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    07/21/2022
    Primary completion :
    09/01/2025
    Completion :
    10/01/2025
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Nerlynx (neratinib) • letrozole • anastrozole
    Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca (NCT03919292)
    Phase 1/2
    Virginia Commonwealth University
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    05/01/2019
    Primary completion :
    05/31/2025
    Completion :
    05/31/2026
    EGFR
    |
    EGFR mutation • RAS mutation
    |
    Nerlynx (neratinib)
    Afatinib in NSCLC With HER2 Mutation (NCT02597946)
    Phase 2
    Boehringer Ingelheim
    Completed
    Last update posted :
    02/19/2025
    Initiation :
    03/18/2016
    Primary completion :
    07/22/2018
    Completion :
    07/22/2018
    HER-2 • KIT
    |
    HER-2 mutation
    |
    Gilotrif (afatinib) • paclitaxel
    Primary Tumor Resection With EGFR TKI for Stage IV NSCLC (NCT05215548)
    Phase 2
    National Taiwan University Hospital
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    09/27/2021
    Primary completion :
    10/01/2026
    Completion :
    10/01/2027
    EGFR
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Gilotrif (afatinib)
    Afatinib in Locally Advanced and Metastatic Chordoma (NCT03083678)
    Phase 2
    Leiden University Medical Center
    Completed
    Last update posted :
    02/13/2025
    Initiation :
    06/21/2018
    Primary completion :
    01/31/2025
    Completion :
    01/31/2025
    EGFR
    |
    EGFR expression
    |
    Gilotrif (afatinib)
    Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer. (NCT01649271)
    Phase 1
    Boehringer Ingelheim
    Completed
    Last update posted :
    02/11/2025
    Initiation :
    07/23/2012
    Primary completion :
    06/23/2016
    Completion :
    06/23/2016
    HER-2
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • Gilotrif (afatinib)
    PLATFORM Study of Precision Medicine for Rare Tumors (NCT04423185)
    Phase 2
    Cancer Institute and Hospital, Chinese Academy ...
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    08/15/2020
    Primary completion :
    07/01/2026
    Completion :
    07/01/2028
    EGFR • HER-2 • BRAF • ALK • MET • BRCA1 • BRCA2 • KIT • ROS1 • CDKN2A
    |
    BRCA2 mutation • BRCA1 mutation • EGFR mutation • HER-2 overexpression • BRAF mutation • HER-2 amplification • MET amplification • KIT mutation • ALK fusion • ROS1 fusion • CDKN2A mutation • MET mutation • BRAF amplification
    |
    Xalkori (crizotinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • imatinib • Tyvyt (sintilimab) • Alecensa (alectinib) • Zejula (niraparib) • Irene (pyrotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib)
    Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer. (NCT00950742)
    Phase 1
    Boehringer Ingelheim
    Completed
    Last update posted :
    02/10/2025
    Initiation :
    08/01/2009
    Primary completion :
    10/01/2013
    Completion :
    10/01/2013
    HER-2
    |
    HER-2 amplification
    |
    Herceptin (trastuzumab) • Gilotrif (afatinib)
    Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation (NCI-2018-01218) (NCT03065387)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    02/10/2025
    Initiation :
    10/31/2017
    Primary completion :
    10/01/2025
    Completion :
    10/01/2025
    HER-2 • KRAS • ERBB3 • ERBB4
    |
    KRAS mutation • EGFR mutation • HER-2 amplification • EGFR amplification
    |
    Mekinist (trametinib) • Ibrance (palbociclib) • everolimus • Nerlynx (neratinib)
    Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease (KAN-HER2 MRD) (NCT05388149)
    Phase 2
    University Health Network, Toronto
    Recruiting
    Last update posted :
    01/31/2025
    Initiation :
    12/06/2022
    Primary completion :
    07/01/2026
    Completion :
    07/01/2026
    HER-2
    |
    HER-2 positive
    |
    Nerlynx (neratinib) • Kadcyla (ado-trastuzumab emtansine)
    Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer (NCT03101748)
    Phase 1/2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    12/13/2024
    Initiation :
    01/29/2018
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    HER-2
    |
    HER-2 positive • HER-2 negative • HER-2 negative + HR negative
    |
    Herceptin (trastuzumab) • paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • doxorubicin hydrochloride • cyclophosphamide • Herzuma (trastuzumab-pkrb) • daunorubicin • Ontruzant (trastuzumab-dttb) • Ogivri (trastuzumab-dkst) • Trazimera (trastuzumab-qyyp) • Herwenda (trastuzumab biosimilar) • GB221 (coprelotamab) • SIBP-01 (trastuzumab biosimilar) • cyclophosphamide intravenous
    Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) (NCT04374305)
    Phase 2
    Scott R. Plotkin, MD, PhD
    Active, not recruiting
    Last update posted :
    11/18/2024
    Initiation :
    06/20/2020
    Primary completion :
    12/01/2029
    Completion :
    12/01/2030
    NF2
    |
    Nerlynx (neratinib) • Alunbrig (brigatinib)
    INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (NCT02977780)
    Phase 2
    Patrick Wen, MD
    Recruiting
    Last update posted :
    10/17/2024
    Initiation :
    02/09/2017
    Primary completion :
    02/01/2027
    Completion :
    04/30/2027
    IDH1
    |
    IDH1 R132
    |
    temozolomide • Nerlynx (neratinib) • Verzenio (abemaciclib) • CC-115 • QBS72S
    Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib (NCT02364609)
    Phase 1
    Jonathan Riess
    Completed
    Last update posted :
    10/16/2024
    Initiation :
    09/30/2015
    Primary completion :
    04/26/2018
    Completion :
    05/01/2020
    PD-L1
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q
    |
    Keytruda (pembrolizumab) • erlotinib • Gilotrif (afatinib)
    Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers (NCT05919108)
    Phase 2
    Vanderbilt-Ingram Cancer Center
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    09/30/2024
    Primary completion :
    04/30/2030
    Completion :
    04/30/2031
    HER-2 • ER • CDH1
    |
    ER positive • HER-2 negative • CDH1 expression
    |
    Nerlynx (neratinib)
    Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (NCI-2022-04099) (NCT05372614)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    10/05/2022
    Primary completion :
    06/17/2024
    Completion :
    06/17/2024
    HER-2 • CD4 • CASP3
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 L755S • HER-2 A775_G776insYVMA • HER-2 S310F • HER-2 V777L • HER-2 G778_P780dup • HER-2 D769Y • HER-2 L869R • HER-2 V842I • HER-2 H878Y • HER-2 L866M • HER-2 A775 • HER-2 G309A • HER-2 P780-Y781insGSP • HER-2 R678Q • HER-2 R896C • HER-2 T862A • HER-2 YVMA
    |
    Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (NCI-2017-00831) (NCT03066206)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    05/24/2024
    Initiation :
    03/17/2017
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    EGFR • HER-2
    |
    EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • HER-2 L755S • HER-2 A775_G776insYVMA • HER-2 V777L • EGFR exon 20 mutation • HER-2 A775 • HER-2 P780-Y781insGSP • HER-2 YVMA • HER-2 exon 19 mutation • HER-2 exon 23 mutation
    |
    Pozenveo (poziotinib)
    HKI-272 for HER2-Positive Breast Cancer and Brain Metastases (NCT01494662)
    Phase 2
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    05/22/2024
    Initiation :
    02/01/2012
    Primary completion :
    02/01/2023
    Completion :
    12/01/2024
    HER-2
    |
    HER-2 positive • HER-2 amplification
    |
    Nerlynx (neratinib) • Kadcyla (ado-trastuzumab emtansine) • capecitabine
    Observational Study of Afatinib 30 mg Daily (NCT04909073)
    Phase N/A
    National University Hospital, Singapore
    Recruiting
    Last update posted :
    05/17/2024
    Initiation :
    10/25/2022
    Primary completion :
    05/01/2025
    Completion :
    12/01/2025
    EGFR
    |
    EGFR mutation • EGFR L858R
    |
    Gilotrif (afatinib)
    Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer (NCT06085755)
    Phase 1/2
    Jeeyun Lee
    Not yet recruiting
    Last update posted :
    05/14/2024
    Initiation :
    06/01/2024
    Primary completion :
    12/01/2025
    Completion :
    12/01/2026
    HER-2
    |
    Gilotrif (afatinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer (NCT06109467)
    Phase 2
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    05/03/2024
    Initiation :
    01/12/2024
    Primary completion :
    04/01/2028
    Completion :
    04/01/2028
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • 5-fluorouracil • Nerlynx (neratinib) • oxaliplatin • leucovorin calcium
    Pemigatinib + Afatinib in Advanced Refractory Solid Tumors (NCT06302621)
    Phase 1
    Massachusetts General Hospital
    Recruiting
    Last update posted :
    04/26/2024
    Initiation :
    07/01/2024
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    FGFR2
    |
    Gilotrif (afatinib) • Pemazyre (pemigatinib)
    Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer (NCT03377387)
    Phase 1/2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    04/18/2024
    Initiation :
    12/13/2017
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    HER-2
    |
    HER-2 overexpression • HER-2 amplification
    |
    Nerlynx (neratinib) • capecitabine
    Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer (NCT05659056)
    Phase 2
    The First Affiliated Hospital with Nanjing Medi...
    Recruiting
    Last update posted :
    04/16/2024
    Initiation :
    11/29/2022
    Primary completion :
    04/01/2024
    Completion :
    07/01/2024
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib) • albumin-bound paclitaxel
    Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B) (NCT04439136)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    04/05/2024
    Initiation :
    08/12/2015
    Primary completion :
    01/22/2021
    Completion :
    03/05/2025
    HER-2
    |
    HER-2 mutation
    |
    Gilotrif (afatinib)
    INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (NCI-2020-02940) (NCT04445844)
    Phase 2
    Mridula George, MD
    Recruiting
    Last update posted :
    04/02/2024
    Initiation :
    07/13/2020
    Primary completion :
    06/30/2024
    Completion :
    09/30/2024
    HER-2 • ER • PGR
    |
    PD-L1 expression • HER-2 expression • ER expression
    |
    Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)
    An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s) (NCT01853826)
    Phase 3
    Boehringer Ingelheim
    Completed
    Last update posted :
    03/26/2024
    Initiation :
    07/17/2013
    Primary completion :
    04/30/2018
    Completion :
    03/06/2024
    EGFR
    |
    EGFR mutation
    |
    Gilotrif (afatinib)
    Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer (NCT05861271)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    03/22/2024
    Initiation :
    06/01/2023
    Primary completion :
    07/01/2026
    Completion :
    07/01/2028
    HER-2
    |
    HER-2 positive • HER-2 amplification • HR negative • PGR expression
    |
    tamoxifen • capecitabine • Irene (pyrotinib) • exemestane
    Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers (NCT06083662)
    Phase 2
    Korea University Guro Hospital
    Active, not recruiting
    Last update posted :
    03/13/2024
    Initiation :
    06/15/2021
    Primary completion :
    11/30/2023
    Completion :
    06/30/2024
    HER-2
    |
    HER-2 mutation
    |
    Nerlynx (neratinib) • Herzuma (trastuzumab-pkrb)
    Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer (NCT06035679)
    Phase N/A
    Youzhi Zhu
    Recruiting
    Last update posted :
    02/28/2024
    Initiation :
    08/17/2023
    Primary completion :
    11/30/2026
    Completion :
    11/30/2026
    HER-2
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • Irene (pyrotinib)
    GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer (NCT05575804)
    Phase 1/2
    Fudan University
    Recruiting
    Last update posted :
    02/26/2024
    Initiation :
    10/01/2022
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    HER-2
    |
    HER-2 positive
    |
    capecitabine • Irene (pyrotinib) • GQ1001
    Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab (YOUNGBC-21) (NCT05572645)
    Phase N/A
    Fudan University
    Completed
    Last update posted :
    02/26/2024
    Initiation :
    10/01/2022
    Primary completion :
    09/01/2023
    Completion :
    09/01/2023
    HER-2
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
    A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations (PINNACLE) (NCT05378763)
    Phase 3
    Spectrum Pharmaceuticals, Inc
    Suspended
    Last update posted :
    02/15/2024
    Initiation :
    05/12/2022
    Primary completion :
    12/25/2027
    Completion :
    12/25/2028
    HER-2
    |
    HER-2 mutation • HER-2 exon 20 mutation • HER-2 exon 23 mutation
    |
    docetaxel • Pozenveo (poziotinib)
    A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases (NCT05042791)
    Phase 2
    Jiangxi Provincial Cancer Hospital
    Recruiting
    Last update posted :
    02/09/2024
    Initiation :
    03/01/2022
    Primary completion :
    09/30/2025
    Completion :
    09/30/2025
    HER-2
    |
    HER-2 positive
    |
    capecitabine • Irene (pyrotinib)
    S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer (NCT02438722)
    Phase 2/3
    SWOG Cancer Research Network
    Active, not recruiting
    Last update posted :
    02/09/2024
    Initiation :
    05/07/2015
    Primary completion :
    09/25/2018
    Completion :
    12/15/2024
    EGFR • HER-2
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Erbitux (cetuximab) • Gilotrif (afatinib)