First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
INSPIRE
A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
4 other identifiers
interventional
633
19 countries
98
Brief Summary
The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2009
Longer than P75 for phase_3
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedStudy Start
First participant enrolled
November 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2012
CompletedResults Posted
Study results publicly available
June 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2020
CompletedJanuary 11, 2022
December 1, 2021
3 years
September 18, 2009
December 21, 2015
December 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival Time (OS)
OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.
Randomization to Death from Any Cause (Up to 31.6 Months)
Secondary Outcomes (9)
Progression-Free Survival (PFS)
Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])
Baseline to Measured Progressive Disease (Up to 30.4 Months)
Time to Treatment Failure (TTF)
Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks
Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
Baseline to Study Completion (Up to 31.6 Months)
- +4 more secondary outcomes
Study Arms (2)
Necitumumab + Pemetrexed + Cisplatin
EXPERIMENTALNecitumumab + Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
ACTIVE COMPARATORPemetrexed + Cisplatin
Interventions
500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
Eligibility Criteria
You may qualify if:
- Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer
- Has Stage IV disease at the time of study entry
- Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (participants with only truly nonmeasurable disease are not eligible)
- Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
- Has an Eastern Cooperative Oncology Group performance status score of 0-2
- Has adequate hepatic function
- Has adequate renal function
- Has adequate hematologic function
- If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method). If male, the participants surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
- Female participants of childbearing potential must have a negative serum
You may not qualify if:
- Has squamous non small cell lung cancer
- Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the Epidermal Growth Factor Hormone (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
- Received previous chemotherapy for advanced NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization)
- Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization
- Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
- Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible
- Has superior vena cava syndrome contraindicating hydration
- Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
- Has experienced myocardial infarction within 6 months prior to randomization
- Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus
- Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance
- Has Grade ≥ 2 peripheral neuropathy
- Has significant third space fluid retention, requiring repeated drainage
- Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the participant's ability to complete the study or sign an informed consent document The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments
- Is pregnant or breastfeeding
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Quintiles, Inc.collaborator
- Parexelcollaborator
- PPD Development, LPcollaborator
- Medidata Solutionscollaborator
- Laboratory Corporation of Americacollaborator
- University of Colorado, Denvercollaborator
- Thermo Fisher Scientific, Inccollaborator
- Pacific Biomarkerscollaborator
- Intertekcollaborator
- Sysmex Inostics GmbHcollaborator
Study Sites (101)
ImClone Investigational Site
Nyack, New York, 10960, United States
ImClone Investigational Site
Kogarah, New South Wales, 2217, Australia
ImClone Investigational Site
Hobart, Tasmania, 7000, Australia
ImClone Investigational Site
East Bentleigh, Victoria, 3165, Australia
ImClone Investigational Site
Rankweil, 6830, Austria
ImClone Investigational Site
Vienna, 1090, Austria
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Vienna, 1130, Austria
ImClone Investigational Site
Duffel, 2570, Belgium
ImClone Investigational Site
Liège, 4000, Belgium
ImClone Investigational Site
Namur, 5000, Belgium
ImClone Investigational Site
Barretos - SP, 14784-400, Brazil
ImClone Investigational Site
Brasilia, Distrito Federal, 70310-050, Brazil
ImClone Investigational Site
Goiania - GO, 74884-606, Brazil
ImClone Investigational Site
IjuĂ, 98700-000, Brazil
ImClone Investigational Site
ItajaĂ, 88301-220, Brazil
ImClone Investigational Site
Lajeado, 95900-000, Brazil
ImClone Investigational Site
Porto Alegre/RS, 90610-000, Brazil
ImClone Investigational Site
RibeirĂ£o Preto - SP, 14015-130, Brazil
ImClone Investigational Site
Salvador, 40050-410, Brazil
ImClone Investigational Site
Santo Andre - SP, 09090-780, Brazil
ImClone Investigational Site
SĂ£o Paulo - SP, 01246-000, Brazil
ImClone Investigational Site
Montreal, Quebec, H3T 1E2, Canada
ImClone Investigational Site
Pula, 52100, Croatia
ImClone Investigational Site
Caen, 14076, France
ImClone Investigational Site
Paris, 75571, France
ImClone Investigational Site
Berlin, 12200, Germany
ImClone Investigational Site
Essen, 45136, Germany
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Frankfurt, 60487, Germany
ImClone Investigational Site
Gauting, 82131, Germany
ImClone Investigational Site
GroĂŸhansdorf, 22927, Germany
ImClone Investigational Site
Halle, 06120, Germany
ImClone Investigational Site
Hamburg, 21075, Germany
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Heidelberg, 69126, Germany
ImClone Investigational Site
Hemer, 58675, Germany
ImClone Investigational Site
Hofheim, 65719, Germany
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Karlsruhe, 76137, Germany
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Lostau, 39291, Germany
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Löwenstein, 74245, Germany
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Mainz, 55131, Germany
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MĂ¼nchen, 81675, Germany
ImClone Investigational Site
MĂ¼nster, 48149, Germany
ImClone Investigational Site
Regensburg, 93053, Germany
ImClone Investigational Site
Ulm, 89081, Germany
ImClone Investigational Site
Athens, 11527, Greece
ImClone Investigational Site
Heraklion, Crete, 71110, Greece
ImClone Investigational Site
PĂ¡trai, 26500, Greece
ImClone Investigational Site
Budapest, 1125, Hungary
ImClone Investigational Site
Budapest, 1145, Hungary
ImClone Investigational Site
Deszk, 6772, Hungary
ImClone Investigational Site
MosonmagyarĂ³vĂ¡r, 9200, Hungary
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SzĂ©kesfehĂ©rvĂ¡r, 8000, Hungary
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Szombathely, 9700, Hungary
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TörökbĂ¡lint, 2045, Hungary
ImClone Investigational Site
Lido di Camaiore, Lucca, 55041, Italy
ImClone Investigational Site
Aviano, Pordenone, 33081, Italy
ImClone Investigational Site
Frosinone, 03100, Italy
ImClone Investigational Site
Genova, 16132, Italy
ImClone Investigational Site
Milan, 20133, Italy
ImClone Investigational Site
Parma, 43100, Italy
ImClone Investigational Site
Perugia, 06126, Italy
ImClone Investigational Site
Olsztyn, 10-357, Poland
ImClone Investigational Site
Otwock, 05-400, Poland
ImClone Investigational Site
Poznan, 60-569, Poland
ImClone Investigational Site
Radom, 26-617, Poland
ImClone Investigational Site
Szczecin, 70-891, Poland
ImClone Investigational Site
Wroclaw, 53-439, Poland
ImClone Investigational Site
Coimbra, 3041-801, Portugal
ImClone Investigational Site
Lisbon, 1649-035, Portugal
ImClone Investigational Site
Brasov, 500366, Romania
ImClone Investigational Site
Bucharest, 022328, Romania
ImClone Investigational Site
Bucharest, 030171, Romania
ImClone Investigational Site
Cluj-Napoca, 400015, Romania
ImClone Investigational Site
Craiova, Dolj, 200385, Romania
ImClone Investigational Site
Iași, 700106, Romania
ImClone Investigational Site
Sibiu, 550245, Romania
ImClone Investigational Site
Ivanovo, 153013, Russia
ImClone Investigational Site
Kirov, 610021, Russia
ImClone Investigational Site
Omsk, 644013, Russia
ImClone Investigational Site
Saint Petersburg, 194044, Russia
ImClone Investigational Site
Saint Petersburg, 197022, Russia
ImClone Investigational Site
Saint Petersburg, 198255, Russia
ImClone Investigational Site
Ufa, 450054, Russia
ImClone Investigational Site
Yaroslavi, 150054, Russia
ImClone Investigational Site
Bratislava, 826 06, Slovakia
ImClone Investigational Site
Nitra, 949 88, Slovakia
ImClone Investigational Site
Bloemfontein, Free State, 9301, South Africa
ImClone Investigational Site
Pretoria, Gauteng, 0001, South Africa
Imclone Investigational Site
Seville, Andalusia, 41013, Spain
ImClone Investigational Site
Barcelona, Catalonia, 08035, Spain
ImClone Investigational Site
Barcelona, Catalonia, 08041, Spain
ImClone Investigational Site
Terrassa, Catalonia, 08221, Spain
ImClone Investigational Site
Madrid, Communidad de Madrid, 28041, Spain
ImClone Investigational Site
Madrid, Communidad de Madrid, 28050, Spain
ImClone Investigational Site
Majadahonda, Communidad de Madrid, 28222, Spain
ImClone Investigational Site
L'Hospitalet de Llobregat, 08908, Spain
ImClone Investigational Site
Aberdeen, AB25 2ZN, United Kingdom
ImClone Investigational Site
Bournemouth, BH7 7DW, United Kingdom
ImClone Investigational Site
Edinburgh, EH4 2XU, United Kingdom
ImClone Investigational Site
Guildford, GU2 7XX, United Kingdom
ImClone Investigational Site
Leeds, LS16 6QB, United Kingdom
ImClone Investigational Site
Preston, PR2 9HT, United Kingdom
Related Publications (1)
Paz-Ares L, Mezger J, Ciuleanu TE, Fischer JR, von Pawel J, Provencio M, Kazarnowicz A, Losonczy G, de Castro G Jr, Szczesna A, Crino L, Reck M, Ramlau R, Ulsperger E, Schumann C, Miziara JE, Lessa AE, Dediu M, Balint B, Depenbrock H, Soldatenkova V, Kurek R, Hirsch FR, Thatcher N, Socinski MA; INSPIRE investigators. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study. Lancet Oncol. 2015 Mar;16(3):328-37. doi: 10.1016/S1470-2045(15)70046-X. Epub 2015 Feb 18.
PMID: 25701171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2009
First Posted
September 22, 2009
Study Start
November 2, 2009
Primary Completion
November 14, 2012
Study Completion
December 23, 2020
Last Updated
January 11, 2022
Results First Posted
June 27, 2016
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and assigned data sharing agreement.