Multicenter Retrospective Study to Evaluate Necitumumab plus Cisplatin/Gemcitabine after Immune-check-point inhibitors in Advanced Squamous-Cell Lung Cancer in Japan (NINJA study) - Multicenter Retrospective Study to Evaluate Necitumumab plus Cisplatin/Gemcitabine after Immune-check-point inhibitors in Advanced Squamous-Cell Lung Cancer in Japan (NINJA study)

Start Date12 Aug 2022

Sponsor / Collaborator

Teikyo University

100 Clinical Results associated with Necitumumab

100 Translational Medicine associated with Necitumumab

100 Patents (Medical) associated with Necitumumab

104

Literatures (Medical) associated with Necitumumab

01 Jun 2025·JCO Precision Oncology

ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor–Mutated Advanced Non–Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib

Article

Author: Piotrowska, Zofia ; Ponce, Santiago ; Yu, Helena A. ; de Langen, Adrianus J. ; Ambrose, Helen ; Yoneshima, Yasuto ; Goldberg, Sarah B. ; Le, Xiuning ; Cho, Byoung Chul ; Riess, Jonathan W. ; Tang, Kwan Ho ; Goldman, Jonathan W. ; Lau, James ; Cavazzina, Riccardo

PURPOSE:

ORCHARD (ClinicalTrials.gov identifier: NCT03944772 ) is a phase II, biomarker-directed platform study designed to characterize resistance mechanisms and evaluate novel drug combinations in patients with epidermal growth factor receptor ( EGFR )–mutated advanced non–small cell lung cancer who have progressed on first-line osimertinib. We report final results of the module assessing the efficacy and safety of osimertinib plus necitumumab (a monoclonal antibody that blocks EGFR) in patients with ≥one of the following: EGFR amplification or select secondary EGFR alterations (L718 or G724 mutation, or exon 20 insertion).

MATERIALS AND METHODS:

Patients received osimertinib (80 mg orally once daily) plus necitumumab (800 mg intravenously, days 1 and 8 of a 3-week cycle) until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) per RECIST 1.1 by investigator assessment.

RESULTS:

Overall, 19 patients received osimertinib plus necitumumab; at data cutoff (April 18, 2023), all patients had discontinued treatment. The ORR was 11% (80% CI, 3 to 26); two patients had a confirmed partial response, with duration of response of 10.4 and 6.0 months; both patients had EGFR amplification. The median progression-free survival was 4.0 months (95% CI, 1.3 to 5.4) and the overall survival was 11.4 months (95% CI, 6.6 to 15.5). Ten patients (53%) had grade ≥3 adverse events, most commonly embolism (not otherwise specified, pulmonary embolism or deep vein thrombosis, reported in four patients; 21%). The safety profile of the combination was consistent with the known profiles of the two individual drugs, and no new signals were identified.

CONCLUSION:

Osimertinib plus necitumumab demonstrated modest clinical benefit, and the overall risk-benefit analysis indicates that further evaluation of the regimen is not warranted in these molecularly defined subsets of osimertinib resistance.

01 Mar 2025·IN VIVO

A Case of EGFR-mutant Squamous Cell Lung Cancer Treated With Necitumumab Combination Therapy

Article

Author: Nomura, Satoshi ; Inomata, Minehiko ; Takata, Naoki ; Furukawa, Daisuke ; Okazawa, Seisuke ; Imanishi, Shingo ; Tokui, Kotaro

BACKGROUND/AIM:

There is insufficient evidence regarding the optimal treatment for squamous cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations, and a standard treatment strategy has not been established.

CASE REPORT:

A 60-year-old woman was diagnosed with advanced EGFR-mutant squamous cell lung cancer. She was treated with EGFR tyrosine kinase inhibitors and then received the combined therapy of cytotoxic agents plus immune checkpoint inhibitors as third-line therapy. She was then treated with the fourth-line combination therapy of cisplatin, gemcitabine, and necitumumab, which resulted in a progression-free survival of 5.0 months and shrinkage of the liver metastatic lesion.

CONCLUSION:

The combination therapy of cisplatin, gemcitabine, and necitumumab was effective in treating pretreated EGFR-mutant squamous cell lung cancer in this case. It is necessary to accumulate more evidence to determine the most effective treatment for advanced EGFR-mutant squamous cell lung cancer.

01 Feb 2025·JTO clinical and research reports

Afatinib and Necitumumab in EGFR-Mutant NSCLC with Acquired Resistance to Tyrosine Kinase Inhibitors

Article

Author: Horn, Leora ; Wakelee, Heather A ; Iams, Wade T ; Reckamp, Karen L ; Myall, Nathaniel J ; Shyr, Yu ; Neal, Joel W ; Berry, Lynne D ; Padda, Sukhmani K ; York, Sally ; Whisenant, Jennifer G

Introduction:

Although tyrosine kinase inhibitors (TKIs) are effective against NSCLC harboring sensitizing EGFR gene mutations, acquired resistance is inevitable. Preclinical studies suggest that combining EGFR TKI and monoclonal antibody therapies may have activity in EGFR-mutated NSCLC that has progressed on TKI therapy alone. Therefore, we prospectively evaluated afatinib plus necitumumab in patients with EGFR-mutated NSCLC.

Methods:

This was a phase 1, dose-escalation, dose-expansion trial assessing the safety and efficacy of afatinib plus necitumumab. Patients had advanced or metastatic EGFR-mutated NSCLC with progression after (1) first-generation TKI if T790M negative, (2) subsequent line third-generation TKI if T790M positive, or (3) third-generation TKI in the first-line setting. Dose-escalation followed a 3+3 design. The primary end point of dose-expansion was objective response rate.

Results:

A total of 22 patients with EGFR-mutated NSCLC were enrolled. The maximum tolerated dose was afatinib 40 mg oral daily plus necitumumab 600 mg intravenous on days 1 and 15 every 28 days. There were no grade 4 to 5 adverse events observed, and seven patients (32%) experienced grade 3 treatment-related adverse events (three rash; one each oral mucositis, diarrhea, headache, ventricular arrhythmia, and tachycardia). In the entire cohort, there were no responses observed, the median progression-free survival was 1.8 months, and the disease control rate was 36% but varied between the subgroups.

Conclusions:

Afatinib plus necitumumab was safe but had limited activity in patients with EGFR-mutated NSCLC. Biomarker studies may identify patient subgroups that are more likely to benefit.

News (Medical) associated with Necitumumab

11 Apr 2023

·www.biospace.com

Ascidian Therapeutics Announces Three Key Development Team Appointments as It Advances Its Lead Program Toward the Clinic

Leadership appointments come as Ascidian's lead program targeting ABCA4 retinopathies, including Stargardt disease, moves through IND-enabling studies BOSTON, April 11, 2023 /PRNewswire/ -- Ascidian Therapeutics, a biotechnology company focused on treating human diseases by rewriting RNA, announced today three new appointments to its growing development team as the company advances its lead program into the clinic. Alia Rashid, MBChB, joins as Vice President, Clinical Development; Sarah DiSalvatore, MPH, has been appointed Vice President, Clinical Operations; and Carmen Jacome, MBA, will serve as Vice President, Program Management. They join as Ascidian prepares for its first-in-human study in its lead program targeting ABCA4 retinopathies and progresses its diversified pipeline of programs in retinal, neurological, neuromuscular, and genetically defined diseases. "This is an exciting and very important time for Ascidian as we advance our lead program using our proprietary platform for rewriting RNA into the clinic," said Jay A. Barth, M.D., Chief Medical Officer of Ascidian Therapeutics. "We're thrilled to welcome Alia, Sarah, and Carmen – who bring deep expertise in their respective areas of focus, with experience-based knowledge from preclinical studies and all phases of clinical development through marketing authorization. I look forward to the many contributions they'll bring to Ascidian for the benefit of patients as we advance this program and move our full pipeline forward to provide breakthrough therapies that address underlying causes of disease." Ascidian's lead program targets ABCA4 retinopathies, including Stargardt disease. Diseases caused by ABCA4 loss of function represent an area of significant unmet need. More patients lose their vision from ABCA4 retinopathy than any other genetic cause, and these diseases are examples of genetic disorders that cannot be addressed by standard gene replacement given the large size of the gene, or by base editing, due to the high mutational variance of the affected gene. Stargardt disease is the most common form of inherited macular degeneration, affecting more than 30,000 individuals in the United States alone, and there are currently no approved treatments. By rewriting RNA, Ascidian's approach has the potential to treat patients with a single dose of a single exon-editing RNA therapeutic. Alia Rashid, MBChB, Vice President, Clinical Development Dr. Rashid joins Ascidian to help lead the clinical elements of the IND submission and oversee clinical studies in ABCA4 retinopathy. She will also help set strategic direction and manage clinical development activities for the company's overall retinal pipeline. As an ophthalmologist with extensive experience in inherited retinal diseases, Dr. Rashid brings expertise in ophthalmic pathology, ophthalmic imaging, and drug development spanning multiple modalities and indications, including AAV-mediated approaches for various retinal conditions. She was the clinical lead for the IND application and designed and oversaw clinical trials for the first functional, recombinant Complement Factor H (CFH) in dry age-related macular degeneration (dry AMD) while at Gemini Therapeutics. As Senior Director and Clinical Development Lead for Ophthalmology at Editas Medicine, Dr. Rashid helped lead clinical development for its CRISPR/Cas9 gene editing technology for patients with Leber congenital amaurosis type 10 (LCA10) – a rare genetic disease that causes blindness. She also focused on phase II and phase IV clinical studies for patients with wet AMD and diabetic retinopathy at Genentech and led pilot studies in ophthalmology innovation and mHealth to improve clinical trials. Dr. Rashid has been named to the "Top 10 Healthcare Trendsetters" and "Boston 40 Under 40 Healthcare Innovators" lists by Medtech. She completed fellowships in ophthalmic pathology at the Massachusetts Eye and Ear/Harvard Medical School and ophthalmic oncology and pathology at Emory University, and earned her medical degree from the University of Birmingham in the UK. Sarah DiSalvatore, MPH, Vice President, Clinical Operations As Vice President of Clinical Operations, Sarah DiSalvatore will be responsible for execution of Ascidian's first ever clinical trials. She brings more than 25 years of experience in end-to-end research and development and wide-ranging expertise across many challenging therapeutic categories and modalities, including both AAV and lentiviral vector (LVV) gene therapies. DiSalvatore's work has directly contributed to FDA marketing authorization of novel treatments and vaccines, including ELZONRIS™, Portrazza®, Cyramza®, Lartruvo®, Prevnar 13®, and Prevnar 7®. Most recently, DiSalvatore served as Vice President of Clinical Operations at AGTC (Applied Genetic Technologies Corporation), managing overall clinical operations for the company's gene therapy trials in rare diseases and ophthalmology. Prior to that, she was Assistant Vice President of Clinical Operations at Rocket Pharma, where she led global gene therapy clinical trials in rare diseases. DiSalvatore also has experience leading teams at both large pharmaceutical companies, such as Roche, as well as biotech startups, including Stemline Therapeutics, where she initiated six clinical trials and contributed to filing three Investigational New Drugs (IND) within three years. DiSalvatore currently serves on the Leadership Advisory Board for the DDX3X Foundation and on the Community Advocacy Committee for Simons Searchlight, an international research program whose mission is to improve the lives of people with rare genetic neurodevelopmental disorders. She earned her B.S. in biology from Salisbury University and her master's degree in public health in epidemiology from New York Medical College. Carmen Jacome, MBA, Vice President, Program Management Carmen Jacome joins Ascidian to lead the company's Program Management function, which will work cross-functionally to meet key deliverables, milestones, and timelines – from drug candidate selection, through clinical proof of concept and full development across Ascidian's diversified pipeline. She brings over 20 years of experience in project leadership including ten product launches across diverse platforms including: ophthalmology, bacterial infections, osteoporosis, multiple sclerosis, and consumer products. Most recently, while at Flexion Therapeutics, Jacome managed launch readiness and commercialization of Zilretta®, the company's first approved product. Jacome's experience encompasses both working with large pharmaceutical companies, such as Pfizer and Novartis, as well as small biotechnology startups, including Thrombogenics, Cempra, Flexion, and Astria Therapeutics. She earned her graduate certificate in program management from Stanford University and her MBA in international business from the Darla Moore School of Business at the University of South Carolina. About Ascidian Therapeutics Ascidian Therapeutics, an ATP company, is redefining the treatment of disease by rewriting RNA. By editing exons at the RNA level, Ascidian therapies enable precise post-transcriptional editing of genes, resulting in full-length, functional proteins at the right levels, in the right cells, at the right time. With active discovery and preclinical programs in ophthalmology, neurological, neuromuscular, and genetically defined diseases, Ascidian's approach has the potential to treat patients with a single dose of a single exon-editing RNA therapeutic and is opening new therapeutic possibilities for patients in need of breakthroughs. For more information, visit .

Executive ChangeGene TherapyPhase 2

03 Oct 2022

·www.prnewswire.com

Evommune Announces Appointment of Dr. Jeegar Patel as Chief Scientific Officer

Leveraging Evommune's human tissue-based discovery platform, Dr. Patel will oversee all aspects of the Company's research and nonclinical activities PALO ALTO, Calif., Oct. 3, 2022 /PRNewswire/ -- Evommune, Inc., a clinical-stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced the appointment of Jeegar Patel, Ph.D., as Chief Scientific Officer. "We are thrilled to welcome Jeegar to our team," said Luis Peña, President and Chief Executive Officer of Evommune. "Jeegar is a highly skilled executive with an outstanding track record and translational expertise in the discovery of therapies for inflammatory diseases. He will oversee all aspects of early-stage programs, as well as our human tissue-based discovery engine." Dr. Patel joins Evommune with significant scientific and biotech industry experience, with a focus on drug discovery, toxicology and the clinical translation of therapeutics from target selection to registrational filing. Dr. Patel most recently served as Senior Vice President, Research and Nonclinical Development at Kadmon Holdings, Inc., a Sanofi Company, where he held positions of increasing responsibility and led the research and development organization with a therapeutic focus in fibrosis, immunology and immuno-oncology. He has directly contributed to IND and NDA filings across multiple therapeutic areas, including the development and approval of Rezurock® (FDA Approved July 2021) which led to Sanofi's $1.9 billion acquisition of Kadmon in late 2021, with Dr. Patel leading Kadmon's R&D activity integration into Sanofi. Prior to joining Kadmon, Dr. Patel was a Nonclinical Development Project Leader at ImClone Systems (Acquired by Eli Lilly in 2008) and led nonclinical development activities supporting the approval of Cyramza® (aVEGFR2 Mab), Portrazza® (aEGFR Mab), and Lartruvo® (aPDGFb Mab). Dr. Patel began his career as a nonclinical development project toxicologist at Abbott Laboratories and Aventis. Dr. Patel received his Bachelor of Science (B.S.) degree in Pharmacology and Toxicology from the University of the Sciences in Philadelphia and his Doctorate in Pharmacology and Physiology (Ph.D.) from Drexel University, College of Medicine. "I'm excited to join the team at Evommune as we work to advance our pipeline of novel therapies for the treatment of chronic inflammatory diseases," said Dr. Patel. "Contributing to the advancement of multiple novel therapeutic approaches for patients across a wide range of diseases who are in need of better treatment options is a unique opportunity. I'm inspired by the energy and focus of the team and the potential to make a difference for patients." About Evommune, Inc. Evommune, Inc. is a private R&D company creating game-changing science to treat immune-mediated inflammatory diseases. The company is evolving immunology through its unique human tissue-based approach to discovering, developing and delivering therapies that address symptoms and halt progressive disease. Evommune was founded in 2020 by an industry-leading team of R&D experts and is headquartered in Palo Alto, California. For more information, please visit Evommune.com. Media Contact: Sheryl Seapy 949-903-4750 [email protected] SOURCE Evommune, Inc.

CollaborateAcquisition

15 Jan 2019

·www.biospace.com

Who’s the Boss? Companies and Their Novel Drug Approvals, 2014-2018

In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look. In 2018, the U.S. Food and Drug Administration (FDA) approved 59 novel drugs, meaning approved new molecular entities (NMEs). The figure for 2017 was 46 novel drugs. The FDA notes, “Each year, CDER [Center for Drug Evaluation and Research] approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.” BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look. #1. AstraZeneca . From 2014 to 2018, AstraZeneca had nine new drugs approved. In 2014, the agency approved AstraZeneca’s Farxiga, Movantik, and Lynparza. Farxiga is for type 2 diabetes; Movantik is prescribed for opioid-induced constipation; Lynparza is prescribed to treat ovarian and breast cancers. In 2015, the FDA approved AstraZeneca’s Tagrisso. Tagrisso is prescribed to treat specific types of non-small cell lung cancer (NSCLC). They skipped a year, then in 2017, the agency approved the company’s Imfinzi, Calquence and Fasenra. Imfinzi is used to treat NSCLC. Calquence is for mantle cell lymphoma, and Fasenra is used to treat severe eosinophilic asthma. In 2018, the FDA approved Lokelma and Lumoxiti. Lokelma is prescribed to treat hyperkalemia. Lumoxiti is used to treat hairy cell leukemia. Approved Drugs: • Farxiga • Movantik • Lynparza • Tagrisso • Imfinzi • Calquence • Fasenra • Lokelma • Lumoxiti #2. Eli Lilly and Company . In the five-year period, Eli Lilly had eight new drug approvals. Lilly’s Cyramza was approved in 2014, as well as its Trulicity. Cyramza was approved for the treatment of advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. Trulicity is used to treat type 2 diabetes. In the first half of 2018, Trulicity brought in $1.46 billion in sales. In 2015, the FDA approved Portrazza to treat squamous non-small cell lung cancer (NSCLC). In 2016, the agency approved Taltz and Lartruvo. Taltz is used to treat active psoriatic arthritis. Lartruvo is used to treat soft tissue sarcoma (STS). The following year, 2017, the FDA approved Lilly’s Verzenio. Verzenio is used to treat breast cancer. In 2018, Olumiant and Emgality were approved. Olumiant is used to treat rheumatoid arthritis. Emgality is prescribed to treat migraine. Approved Drugs: • Cyramza • Trulicity • Portrazza • Taltz • Lartruvo • Verzenio • Olumiant • Emgality #3. Merck & Company . From 2014 to 2018, the FDA approved seven of Merck’s novel drugs. In 2014, the FDA approved Merck’s Belsomra and Keytruda. Belsomra is a sleep medication. Keytruda, of course, is Merck’s checkpoint inhibitor that has been approved for a broad range of cancer indications. In 2017, Keytruda brought in more than $3.8 billion. There were no approvals in 2015, but in 2016, Merck’s Zepatier and Zinplava were approved. Zepatier is used to treat hepatitis C. Zinplava is used to treat Clostridium difficile infection. The FDA approved Prevymis and Steglatro in 2017, and Pifeltro in 2018. Prevymis is used to prevent cytomegalovirus (CMV) infection. Steglatro is prescribed for type 2 diabetes. Pifeltro is used to treat HIV. Approved Drugs: • Belsomra • Keytruda • Zepatier • Zinplava • Prevymis • Steglatro • Pifeltro #4.(T) Genentech . Over this period, Genentech, a Roche company, had six novel drugs approved by the FDA. The first approval, in 2014, was for Esbriet, for idiopathic pulmonary fibrosis (IPF). In 2015, the FDA approved Cotellic, which is used with Zelboraf to treat melanoma. In 2015, Tecentriq was approved for non-squamous NSCLC and bladder cancer. Tecentriq is an anti-PD-L1 checkpoint inhibitor. In 2017, the FDA approved Ocrevus for multiple sclerosis (MS) and Hemlibra for hemophilia A. In 2018, Genentech’s Xofluza was approved to treat influenza. As a side note, in 2015, the FDA approved Roche’s Alecensa to treat NSCLC. Approved Drugs: • Esbriet • Cotellic • Tecentriq • Ocrevus • Hemlibra • Xofluza • Alecensa (Roche) #4.(T) Gilead Sciences . Like Genentech, Gilead had six novel drugs approved by the FDA from 2014 to 2018. The FDA approved Gilead’s Zydelig and Harvoni in 2014. Zyedelig is prescribed for relapsed follicular lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma. Harvoni is used to treat hepatitis C. A year later, the agency approved Gilead’s Genvoya, a four-drug combination for hepatitis B (HBV). In 2016, Epclusa, a two-drug combination for HCV, was approved. The FDA approved Vosevi in 2017 for HCV. And in 2018, FDA approved Biktarvy for HIV. Gilead’s HCV treatments have been so good, they essentially cure the disease, which has led to falling sales as the patient population decreases. Good for patients, not so good for the company. In a three-year period, Gilead’s flagship HCV drugs brought in more than $44 billion. Approved Drugs: • Zydelig • Harvoni • Genvoya • Epclusa • Vosevi • Biktarvy #4(T). Novartis . Novartis ties with Genentech and Gilead Sciences, having had six new drugs approved in the five-year period. 2014 marked the approval of Zykadia for NSCLC. In 2015, the FDA approved Cosentyx, Farydak and Entresto. Cosentyx is used to treat plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. Farydak is for the treatment of multiple myeloma. Entresto is used to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure. The agency approved Kisqali for breast cancer and Rydapt for acute myeloid leukemia in 2017 Approved Drugs: • Zykadia • Cosentyx • Farydak • Entresto • Kisqali • Rydapt Rounding out the top 12, Allergan , Janssen (a division of Johnson & Johnson ) , and Pfizer all had five drugs approved in the five-year period. After those three, AbbVie , Amgen and Boehringer Ingelheim followed, each of the companies having four drugs approved between 2014 and 2018.

Drug Approval

100 Deals associated with Necitumumab

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KEGG	Wiki	ATC	Drug Bank
D10018	Necitumumab	L01XC22	DB09559

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Squamous non-small cell lung cancer	Canada	Eli Lilly Canada, Inc.	16 Mar 2017
EGFR positive non-small cell lung cancer	European Union	Eli Lilly Nederland BV	15 Feb 2016
EGFR positive non-small cell lung cancer	Iceland	Eli Lilly Nederland BV	15 Feb 2016
EGFR positive non-small cell lung cancer	Liechtenstein	Eli Lilly Nederland BV	15 Feb 2016
EGFR positive non-small cell lung cancer	Norway	Eli Lilly Nederland BV	15 Feb 2016
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	24 Nov 2015
Non-squamous non-small cell lung cancer	United States	Eli Lilly & Co.	24 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Austria	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Belgium	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Croatia	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	Eli Lilly & Co.	07 Jan 2010
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Greece	Eli Lilly & Co.	07 Jan 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCTs041220070 (WJOG15021M, ESMO2025)	Phase 2	EGFR mutation Solid Tumors EGFR amplification	22	Necitumumab	lhhxfihxis(bvjrljpfsk) = ejwaebaini vocatyueqm (gwziokkulu, 9.6 - 37.8) View more	Negative	17 Oct 2025
				Necitumumab (ESCC)	lhhxfihxis(bvjrljpfsk) = grfkfdwuxo vocatyueqm (gwziokkulu )
JPRN-jRCTs051200138 (WJOG14120L NESSIE, ESMO2024) Manual	Phase 2	Advanced Lung Squamous Cell Carcinoma	46	Cisplatin and gemcitabine plus necitumumab (CGN)	ebdibvtigl(tdlhacccss) = hykfrtvqzq xeqxeyucnm (xeidfqprjv, 17.7 - 36.2) View more	Positive	14 Sep 2024
JPRN-jRCT2031200248 (K-TAIL-202, AACR2024) Manual	Phase 2	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1 Expression	50	Pembrolizumab anNecitumumabab	sohajtuydg(hwqrtgqkwy) = yuaybrrjpx dshslzumkk (dluhqztlva, 61.9 - 86.9) View more	Positive	05 Apr 2024
NCT02789345 (JVDL, CTgov)	Phase 1	EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	29	Ramucirumab+Osimertinib (Arm A: Ramucirumab + Osimertinib)	qbogtcgndm = vbjnqxbibc usobkfxhup (kiaajabagc, atjnomsmkg - hbohompkzx) View more	-	05 Feb 2024
				Osimertinib+Necitumumab (Arm B: Necitumumab + Osimertinib)	qbogtcgndm = xkmomdsihg usobkfxhup (kiaajabagc, isnekmkagl - hobcpwrwwi) View more
NCT04285671 (UCLA L-08, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Refractory Lung Carcinoma EGFR Mutation	22	Necitumumab+Osimertinib+Trastuzumab	ekbklkpetm(thykljzdut) = eebobxnhnk nnjkfsjwwg (oawwmzfkff ) View more	Positive	31 May 2023
NCT02443337 (CTgov)	Phase 2	squamous cell lung carcinoma \| metastatic non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	31	LY3023414+Necitumumab (Lead in Cohort LY3023414 + Necitumumab)	pjfqneebrq = llxihecype rhyctyqbgd (nftodeycuj, rfgqfjpwxc - kxlrvhivte) View more	-	09 Dec 2020
				LY3023414+Necitumumab (Post Lead in Cohort LY3023414 + Necitumumab)	pjfqneebrq = glwmmjsxxz rhyctyqbgd (nftodeycuj, niopjehlwg - aswlbpbkvd) View more
NCT02451930 (CTgov)	Phase 1	metastatic non-small cell lung cancer	71	Neci+Pembro (Part A Cohort 1: 600 mg Neci + 200 mg Pembro)	phfsnutqde = ewuoyutmzy rvbapzpyku (nvpympyeav, ufnvaujftg - tekkewakza) View more	-	05 Oct 2020
				Neci+Pembro (Part A Cohort 2: 800 mg Neci + 200 mg Pembro)	phfsnutqde = rzkaceohdv rvbapzpyku (nvpympyeav, vbrtevvdjx - cmltrsjxpc) View more
NCT03574818 (CTgov)	Phase 2	squamous cell lung carcinoma	1	Evaluation to determine if patient is a candidate to proceeed with surgical resection or not+Gemcitabine+Cisplatin+necitumumab	jirckkogyf = doyhxxdqeo uuzwfkiref (jbyupekufc, qcpizooruc - tuxtygtqdw) View more	-	18 Feb 2020
NCT00981058 (SQUIRE, Pubmed \| Lung Cancer) Manual	Phase 2	Squamous non-small cell lung cancer First line	54	Necitumumab+nab-paclitaxel+carboplatin	xwpomaixhv(wrkxaymkna) = dnwfcjgjky iptejymtpw (slcgyfwghb ) View more	Positive	01 Oct 2019
NCT01763788 \| JPRN-JapicCTI-132085 (JPRN, Pubmed \| Lung Cancer) Manual	Phase 1/2	Non-Small Cell Lung Cancer	181	Gemcitabine+Cisplatin+necitumumab	zgonydrssq(jpsbjpywko) = vhzjwortza sgulpacszv (xkisvhpssl, 92.4 – 99.8) View more	Positive	18 Jun 2019
				Gemcitabine+Cisplatin	zgonydrssq(jpsbjpywko) = kxdtuxlzwe sgulpacszv (xkisvhpssl, 88.7 – 98.3) View more

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