Study Summary
This trial is testing a new drug to see if it's more effective than standard chemotherapy for lung cancer.
Eligible Conditions
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 3
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 31 Months
31 Months
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Baseline through 31 Months
Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
Month 31
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
Week 3
Malignant Neoplasms
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
Month 24
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Month 31
Overall Survival Time (OS)
Month 31
Progression-Free Survival (PFS)
Month 31
Time to Treatment Failure (TTF)
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Side Effects for
Pemetrexed+Cisplatin
59%Nausea
33%Vomiting
32%Neutropenia
31%Anorexia
30%Fatigue
29%Anaemia
27%Constipation
22%Asthenia
16%Diarrhoea
15%Cough
13%Dyspnoea
13%Oedema peripheral
12%Leukopenia
12%Hypomagnesaemia
10%Dysgeusia
9%Mucosal inflammation
9%Headache
9%Hypertension
8%Weight decreased
8%Dizziness
8%Abdominal pain upper
7%Pyrexia
7%Hypokalaemia
7%Thrombocytopenia
6%Back pain
6%Alopecia
6%Rash
6%Blood creatinine increased
6%Dyspepsia
6%Hyponatraemia
5%Musculoskeletal pain
5%Pain in extremity
5%Insomnia
5%Non-cardiac chest pain
5%Tinnitus
5%Lacrimation increased
5%Urinary tract infection
5%Lymphopenia
5%Abdominal pain
4%Hypocalcaemia
4%Pulmonary embolism
4%Dry skin
4%Fluid retention
4%Stomatitis
3%Paraesthesia
3%Hyperglycaemia
3%Epistaxis
3%Depression
3%Non-small cell lung cancer
3%Haemoptysis
3%Pruritus
2%Pneumonia
2%Oral candidiasis
2%Dehydration
2%Renal failure
2%Productive cough
2%Rash generalised
2%Conjunctivitis
1%Infection
1%Respiratory tract infection
1%Febrile neutropenia
1%Incorrect dose administered
1%Cerebrovascular accident
1%Hemiparesis
1%General physical health deterioration
1%Medication error
1%Respiratory failure
1%Arthralgia
1%Circulatory collapse
1%Atrial fibrillation
1%Bronchitis
1%Pericardial effusion
1%Cerebral infarction
1%Pleural effusion
1%Spinal cord compression
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2 Treatment Groups
Gemcitabine + Cisplatin
1 of 2
Necitumumab + Gemcitabine + Cisplatin
1 of 2
Active Control
Experimental Treatment
1093 Total Participants · 2 Treatment Groups
Primary Treatment: Necitumumab · No Placebo Group · Phase 3
Necitumumab + Gemcitabine + CisplatinExperimental Group · 3 Interventions: Necitumumab, Gemcitabine, Cisplatin · Intervention Types: Biological, Drug, Drug
Gemcitabine + CisplatinActiveComparator Group · 2 Interventions: Gemcitabine, Cisplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Necitumumab
FDA approved
Gemcitabine
FDA approved
Cisplatin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 31 months
Who is running the clinical trial?
Thermo Fisher Scientific FSOTHER
1 Previous Clinical Trials
16 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,497 Previous Clinical Trials
3,152,426 Total Patients Enrolled
ParexelIndustry Sponsor
285 Previous Clinical Trials
92,626 Total Patients Enrolled
PPDIndustry Sponsor
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31,306 Total Patients Enrolled
Medidata SolutionsIndustry Sponsor
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8,919 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
25 Previous Clinical Trials
8,835 Total Patients Enrolled
University of Colorado, DenverOTHER
1,639 Previous Clinical Trials
1,658,461 Total Patients Enrolled
Thermo Fisher Scientific, IncIndustry Sponsor
23 Previous Clinical Trials
20,193 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
45 Previous Clinical Trials
12,354 Total Patients Enrolled
Pacific BiomarkersOTHER
3 Previous Clinical Trials
964 Total Patients Enrolled
Sysmex Inostics GmbHIndustry Sponsor
1 Previous Clinical Trials
633 Total Patients Enrolled
IntertekIndustry Sponsor
3 Previous Clinical Trials
727 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,278 Previous Clinical Trials
378,876 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Paz-Ares, L., M.A. Socinski, J. Shahidi, R.R. Hozak, V. Soldatenkova, R. Kurek, M. Varella-Garcia, N. Thatcher, and F.R. Hirsch. 2016. “Correlation of Egfr-expression with Safety and Efficacy Outcomes in SQUIRE: A Randomized, Multicenter, Open-label, Phase III Study of Gemcitabine–cisplatin Plus Necitumumab Versus Gemcitabine–cisplatin Alone in the First-line Treatment of Patients with Stage IV Squamous Non-small-cell Lung Cancer”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdw214.
- Reck, Martin, Mark A. Socinski, Alexander Luft, Aleksandra Szczęsna, Mircea Dediu, Rodryg Ramlau, György Losonczy, et al.. 2016. “The Effect of Necitumumab in Combination with Gemcitabine Plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial”. Journal of Thoracic Oncology. Elsevier BV. doi:10.1016/j.jtho.2016.03.002.
- Ciuleanu, Tudor, Mark A. Socinski, Coleman Obasaju, Alexander V. Luft, Aleksandra Szczesna, Wojciech Szafrański, Rodryg Ramlau, et al.. 2018. “Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients with Stage IV Squamous Non–small-cell Lung Cancer”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2017.10.004.
- Thatcher, Nick, Fred R Hirsch, Alexander V Luft, Aleksandra Szczesna, Tudor E Ciuleanu, Mircea Dediu, Rodryg Ramlau, et al.. 2015. “Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin Alone as First-line Therapy in Patients with Stage IV Squamous Non-small-cell Lung Cancer (SQUIRE): An Open-label, Randomised, Controlled Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00021-2.
- Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafranski W, Ramlau R, Balint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.
- Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.
- Reck M, Socinski MA, Luft A, Szczesna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.
- 2010. "First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00981058.
Frequently Asked Questions
What other scientific tests have been done that included Necitumumab?
"Necitumumab is being researched in 1012 different active studies, with 347 of those studies taking place during Phase 3. Necitumumab clinical trials are located all over the world, but especially in Shanghai, China." - Anonymous Online Contributor
Unverified Answer
Are patients currently being enrolled in this trial?
"Right now, this study isn't looking for any new participants. It was first posted on January 7th, 2010 and updated February 4th, 2022. If you're interested in other trials, 2095 studies are currently recruiting patients with lung cancer and 1012 Necitumumab trials have open enrolment." - Anonymous Online Contributor
Unverified Answer
For what purpose is Necitumumab most commonly prescribed?
"Necitumumab is not only indicated for the treatment of neoplasm metastasis, but also useful in treating other conditions like urinary bladder and advanced testicular cancer." - Anonymous Online Contributor
Unverified Answer
What is the FDA's decision on Necitumumab?
"There is both anecdotal and scientific evidence supporting the safety of Necitumumab, so it received a score of 3." - Anonymous Online Contributor
Unverified Answer
How many individuals are enrolled in this clinical trial?
"Presently, this trial is not seeking any more participants. It was first posted on January 7th 2010 and received its last edit on February 4th 2022. However, there are 2095 other studies involving lung cancer that are actively recruiting patients as well as 1012 for Necitumumab." - Anonymous Online Contributor
Unverified Answer
In how many different medical clinics is this trial being run today?
"Currently, this clinical trial is enrolling patients from a total of 18 sites. While Saskatoon, Baltimore and Sacramento are some of the locations, it is worth investigating the other 14 to see if one suits you better in order to minimize travel time commitments." - Anonymous Online Contributor
Unverified Answer