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    DRUG:

    Portrazza (necitumumab)

    i
    Other names: IMC-11F8, LY-3012211
    Company:
    Eli Lilly, Nippon Kayaku
    Drug class:
    EGFR inhibitor
    Related drugs:
    8d
    A Case of Advanced Biliary Tract Cancer With EGFR Amplification That Responded to Necitumumab. (PubMed, Cancer Rep (Hoboken))
    This report supports the clinical benefit of anti-EGFR antibodies for EGFR-amplified biliary tract cancers and the importance of genomic analysis in personalized therapy and drug resistance research.
    Journal • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR amplification
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    1m
    Transforming Lung Cancer Management: A Promising Case Study of Immune Checkpoint Inhibitor Success Following a Multidisciplinary Approach. (PubMed, Diagnostics (Basel))
    Two years after initial treatment, cancer relapse led to the administration of nivolumab, which was halted due to the development of drug-induced pneumonitis...Four years after her diagnosis, the patient received a ninth-line therapy combining cisplatin, gemcitabine, and necitumumab, followed by palliative neck radiation due to increasing lymph node size. Remarkable tumor regression occurred three months after introducing atezolizumab as the tenth-line treatment, suggesting that previous treatments, particularly radiotherapy and cisplatin, might have enhanced PD-L1 expression, aligning with the existing literature. This case highlights the urgent need for further research to elucidate the intricate interplay between treatment history and PD-L1 expression in squamous cell carcinoma, emphasizing the importance of accumulating case studies to inform therapeutic strategies.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • gemcitabine • Portrazza (necitumumab)
    4ms
    QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov)
    P1/2, N=4, Terminated, ImmunityBio, Inc. | N=65 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
    Enrollment change • Trial termination
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Portrazza (necitumumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-021 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
    4ms
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Completed, Eli Lilly and Company | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    4ms
    Effects of N361 Glycosylation on Epidermal Growth Factor Receptor Biological Function. (PubMed, bioRxiv)
    EGFR transduces signals from growth factors into cell proliferation and is frequently hyperactivated in tumors. Glycosylation of EGFR at N361 regulates EGFR dimerization, growth factor stimulation of proliferative signaling, and susceptibility to targeted inhibition. Insights into EGFR glycosylation may expand therapeutic opportunities to benefit cancer patients.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    Portrazza (necitumumab)
    5ms
    Enhancing neutrophil cytotoxicity of a panel of clinical EGFR antibodies by Fc engineering to IgA3.0. (PubMed, Mol Cancer Ther)
    Therefore, we reformatted six therapeutic EGFR antibodies (cetuximab, panitumumab, nimotuzumab, necitumumab, zalutumumab, and matuzumab) into the IgA3.0 format, which is an IgA2 isotype that has been adapted for clinical application. IgA3.0 matuzumab exhibited reduced receptor internalization compared to the other antibodies, possibly accounting for its superior in vivo Fc-mediated tumor cell killing efficacy. In conclusion, reformatting EGFR antibodies into an IgA3.0 format increased Fc-mediated killing while retaining Fab-mediated functions and could therefore be a good alternative for the currently available antibody therapies.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Erbitux (cetuximab) • Vectibix (panitumumab) • TheraCIM (nimotuzumab) • Portrazza (necitumumab) • HuMax-EGFR (zalutumumab) • matuzumab (EMD 72000)
    5ms
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    6ms
    Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor (clinicaltrials.gov)
    P1, N=138, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tagrisso (osimertinib) • Portrazza (necitumumab)
    8ms
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2023 --> Jun 2024
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    9ms
    Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov)
    P2, N=248, Active, not recruiting, AstraZeneca | Trial completion date: Nov 2025 --> May 2025 | Trial primary completion date: Nov 2025 --> May 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • Imfinzi (durvalumab) • gefitinib • Koselugo (selumetinib) • Alecensa (alectinib) • Retevmo (selpercatinib) • pemetrexed • etoposide IV • Orpathys (savolitinib) • datopotamab deruxtecan (DS-1062a) • Portrazza (necitumumab)
    10ms
    Enhancement of Antitumor Effect by the Combined Use of Anti-EGFR Antibody(Necitumumab)and PD-1 Inhibitor (PubMed, Gan To Kagaku Ryoho)
    Necitumumab enhances antitumor immunity by decreasing the PD-L1 expression; it is expected to improve the prognosis of patients treated with an immune checkpoint inhibitor(ICI)by inhibiting the IL-8 expression. Since the combined effect of necitumumab and PD-L1 inhibitor was confirmed in an in vivo study conducted in transgenic mice, further antitumor effects can be expected by the combined use of necitumumab and ICI.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    PD-L1 expression • CXCL8 expression
    |
    Portrazza (necitumumab)
    12ms
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    EGFR mutation • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    12ms
    Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov)
    P2, N=250, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • Imfinzi (durvalumab) • gefitinib • Koselugo (selumetinib) • Alecensa (alectinib) • Retevmo (selpercatinib) • pemetrexed • etoposide IV • Orpathys (savolitinib) • datopotamab deruxtecan (DS-1062a) • Portrazza (necitumumab)
    over1year
    Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor (clinicaltrials.gov)
    P1, N=138, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR exon 20 mutation • EGFR T790M negative
    |
    Tagrisso (osimertinib) • Portrazza (necitumumab)
    over1year
    UCLA l-08: A phase ib/II study of combined HER inhibition adding necitumumab and trastuzumab to osimertinib in patients with refractory EGFR-mutated lung cancer. (ASCO 2023)
    ONT toxicities are manageable, and the combination has promising preliminary efficacy in refractory EGFR-mutated metastatic NSCLC. Evaluation of phase 2, stage 1 is expected to be completed by April 2023 and will be reported at the meeting. Clinical trial information: NCT04285671.
    Clinical • P1/2 data
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation
    |
    Herceptin (trastuzumab) • Tagrisso (osimertinib) • Portrazza (necitumumab)
    over1year
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jul 2023 --> Dec 2023
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR expression • EGFR overexpression • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    almost2years
    Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    over2years
    Phase 1b/2 Study of Combined HER Inhibition in Refractory EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2022)
    This is a single-arm, multi-center, open-label phase 1b/2 study to identify the recommended phase 2 dose (RP2D), safety, tolerability, and preliminary efficacy of the combination of osimertinib, necitumumab, and trastuzumab (ONT) in adults with histologically confirmed, metastatic NSCLC with an activating and sensitizing EGFR mutation who have progressed on osimertinib. ONT toxicities are manageable, and the combination has promising preliminary efficacy in EGFR-mutated metastatic NSCLC patients. The trial will continue to enroll.
    P1/2 data
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q
    |
    Herceptin (trastuzumab) • Tagrisso (osimertinib) • Portrazza (necitumumab)
    over2years
    A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer (clinicaltrials.gov)
    P1, N=29, Completed, Eli Lilly and Company | Active, not recruiting --> Completed | N=74 --> 29 | Trial completion date: Nov 2022 --> May 2022
    Trial completion • Enrollment change • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR T790M
    |
    Tagrisso (osimertinib) • Cyramza (ramucirumab) • Portrazza (necitumumab)
    over2years
    Osimertinib plus necitumumab in EGFR-mutant NSCLC: Final results from an ETCTN California Cancer Consortium phase I study. (ASCO 2022)
    Osi/Neci is feasible and tolerable at the RP2D. EGFR ctDNA was detectable at baseline in the majority of pts with decrease in AF on treatment. Osi/Neci was active in select settings of EGFR-TKI resistance, meeting its prespecified efficacy endpoint in T790Mneg PD on 1st/2nd gen TKI as last therapy (ExC A), EGFR ex20ins post-chemo (ExC D) and PD on 1L osimertinib (ExC E).
    Clinical • P1 data
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Portrazza (necitumumab)
    over2years
    Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=22, Terminated, Vanderbilt-Ingram Cancer Center | N=60 --> 22 | Trial completion date: Jul 2023 --> Mar 2022 | Recruiting --> Terminated | Trial primary completion date: Jul 2022 --> Mar 2022; Low accrual
    Preclinical • Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M negative
    |
    Gilotrif (afatinib) • Portrazza (necitumumab)
    almost3years
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jul 2022 --> Jul 2023
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR expression • EGFR overexpression • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    almost3years
    Objective Quantitation of EGFR Protein Levels using Quantitative Dot Blot Method for the Prognosis of Gastric Cancer Patients. (PubMed, J Gastric Cancer)
    A QDB-based assay was developed for gastric cancer specimens to measure EGFR protein levels absolutely, quantitatively, and objectively. This assay should facilitate clinical trials aimed at evaluation of anti-EGFR therapies retrospectively and prospectively for gastric cancer.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR overexpression
    |
    Erbitux (cetuximab) • Portrazza (necitumumab)
    almost3years
    Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov)
    P2, N=210, Recruiting, AstraZeneca | N=150 --> 210
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • Imfinzi (durvalumab) • gefitinib • Koselugo (selumetinib) • Alecensa (alectinib) • Retevmo (selpercatinib) • pemetrexed • etoposide IV • Orpathys (savolitinib) • Portrazza (necitumumab)
    almost3years
    A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer (clinicaltrials.gov)
    P1, N=74, Active, not recruiting, Eli Lilly and Company | Trial completion date: Nov 2021 --> Nov 2022
    Clinical • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR T790M
    |
    Tagrisso (osimertinib) • Cyramza (ramucirumab) • Portrazza (necitumumab)
    almost3years
    Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov)
    P2, N=150, Recruiting, AstraZeneca | Trial completion date: May 2025 --> Nov 2025 | Trial primary completion date: May 2025 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • Imfinzi (durvalumab) • gefitinib • Koselugo (selumetinib) • Alecensa (alectinib) • Retevmo (selpercatinib) • pemetrexed • etoposide IV • Orpathys (savolitinib) • Portrazza (necitumumab)
    3years
    INSPIRE: First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (clinicaltrials.gov)
    P3, N=633, Completed, Eli Lilly and Company | Trial completion date: Jul 2021 --> Dec 2020 | Active, not recruiting --> Completed
    Clinical • Trial completion • Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    cisplatin • pemetrexed • Portrazza (necitumumab)
    over3years
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jul 2021 --> Jul 2022
    Clinical • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR expression • EGFR overexpression • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    over3years
    A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer (clinicaltrials.gov)
    P1, N=74, Active, not recruiting, Eli Lilly and Company | Trial completion date: May 2021 --> Nov 2021
    Clinical • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR T790M
    |
    Tagrisso (osimertinib) • Cyramza (ramucirumab) • Portrazza (necitumumab)
    over3years
    Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (clinicaltrials.gov)
    P2, N=150, Recruiting, AstraZeneca | Trial completion date: Nov 2023 --> May 2025 | Trial primary completion date: Nov 2023 --> May 2025
    Clinical • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • carboplatin • Imfinzi (durvalumab) • gefitinib • Alecensa (alectinib) • Retevmo (selpercatinib) • pemetrexed • Orpathys (savolitinib) • Portrazza (necitumumab)
    over3years
    Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Portrazza (necitumumab)
    almost4years
    Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Vanderbilt-Ingram Cancer Center | Trial completion date: Dec 2022 --> Jul 2023 | Trial primary completion date: Dec 2021 --> Jul 2022
    Clinical • Preclinical • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M negative
    |
    Gilotrif (afatinib) • Portrazza (necitumumab)
    almost4years
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jan 2021 --> Jul 2021
    Clinical • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR expression • EGFR overexpression • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    almost4years
    INSPIRE: First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (clinicaltrials.gov)
    P3, N=633, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jan 2021 --> Jul 2021
    Clinical • Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    cisplatin • pemetrexed • Portrazza (necitumumab)
    almost4years
    [VIRTUAL] Afatinib and Necitumumab in EGFR mutant NSCLC with Acquired Resistance to 1st or 3rd Generation EGFR Tyrosine Kinase Inhibitors (IASLC-WCLC 2020)
    Introduction There are no approved targeted therapies for patients (pts) with EGFR mutated NSCLC who develop acquired resistance to frontline 3rd generation (gen) tyrosine kinase inhibitors (TKI) osimertinib (osi), 2nd line osi (T790MPOS after 1st/2nd gen TKI), or frontline 1st/2nd gen TKI and T790MNEG. Conclusion The combination of afatinib and necitumumab had expected toxicities of rash and diarrhea. Trial is ongoing, and the MTD of afatinib 40 mg and necitumumab 600 mg is being tested in 3 dose expansion cohorts.
    Preclinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • Gilotrif (afatinib) • Portrazza (necitumumab)
    4years
    Necitumumab plus platinum-based chemotherapy versus chemotherapy alone as first-line treatment for stage IV non-small cell lung cancer: a meta-analysis based on randomized controlled trials. (PubMed, Ann Palliat Med)
    With a longer PFS and a higher DCR, NC treatment seemed to be more suitable for treating stage IV NSCLC as first-line therapy, especially for those with high EGFR expression, but its AEs could not be ignored.
    Retrospective data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    Portrazza (necitumumab)
    over4years
    INSPIRE: First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (clinicaltrials.gov)
    P3, N=633, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jul 2020 --> Jan 2021
    Clinical • Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR overexpression
    |
    cisplatin • pemetrexed • Portrazza (necitumumab)
    over4years
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jul 2020 --> Jan 2021
    Clinical • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR expression • EGFR overexpression • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    over4years
    Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Vanderbilt-Ingram Cancer Center | Suspended --> Recruiting
    Clinical • Enrollment open • Preclinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M negative
    |
    Gilotrif (afatinib) • Portrazza (necitumumab)
    over4years
    Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=60, Suspended, Vanderbilt-Ingram Cancer Center | Recruiting --> Suspended
    Clinical • Preclinical • Trial suspension
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M negative
    |
    Gilotrif (afatinib) • Portrazza (necitumumab)
    over4years
    [VIRTUAL] Phase I trial of combination afatinib (Afat) and necitumumab (Neci) in EGFR mutation positive non-small cell lung cancer (NSCLC) with acquired resistance to first or third generation EGFR tyrosine kinase inhibitors (TKIs). (ASCO 2020)
    No abstract available
    P1 data
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Gilotrif (afatinib) • Portrazza (necitumumab)
    over4years
    A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer (clinicaltrials.gov)
    P1, N=74, Active, not recruiting, Eli Lilly and Company | Trial completion date: May 2020 --> May 2021
    Clinical • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR T790M
    |
    Tagrisso (osimertinib) • Cyramza (ramucirumab) • Portrazza (necitumumab)