First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
NCT ID: NCT00982111
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
633 participants
INTERVENTIONAL
2009-11-02
2020-12-23
Brief Summary
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Detailed Description
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Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization).
Participants will undergo radiographic assessment (computed tomography or magnetic resonance imaging) of disease status every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (Or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
After the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Necitumumab + Pemetrexed + Cisplatin
Necitumumab + Pemetrexed + Cisplatin
Pemetrexed
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
Cisplatin
75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Necitumumab
800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Pemetrexed
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
Cisplatin
75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Interventions
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Pemetrexed
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
Cisplatin
75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
Necitumumab
800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Has a known history of drug abuse
* Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Parexel
INDUSTRY
PPD Development, LP
INDUSTRY
Medidata Solutions
INDUSTRY
Laboratory Corporation of America
INDUSTRY
University of Colorado, Denver
OTHER
Thermo Fisher Scientific, Inc
INDUSTRY
Pacific Biomarkers
OTHER
Intertek
INDUSTRY
Sysmex Inostics GmbH
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Nyack, New York, United States
ImClone Investigational Site
Kogarah, New South Wales, Australia
ImClone Investigational Site
Hobart, Tasmania, Australia
ImClone Investigational Site
East Bentleigh, Victoria, Australia
ImClone Investigational Site
Rankweil, , Austria
ImClone Investigational Site
Vienna, , Austria
ImClone Investigational Site
Vienna, , Austria
ImClone Investigational Site
Duffel, , Belgium
ImClone Investigational Site
Liège, , Belgium
ImClone Investigational Site
Namur, , Belgium
ImClone Investigational Site
Barretos - SP, , Brazil
ImClone Investigational Site
Brasilia, Distrito Federal, , Brazil
ImClone Investigational Site
Goiania - GO, , Brazil
ImClone Investigational Site
Ijuí, , Brazil
ImClone Investigational Site
Itajaí, , Brazil
ImClone Investigational Site
Lajeado, , Brazil
ImClone Investigational Site
Porto Alegre/RS, , Brazil
ImClone Investigational Site
Ribeirão Preto - SP, , Brazil
ImClone Investigational Site
Salvador, , Brazil
ImClone Investigational Site
Santo Andre - SP, , Brazil
ImClone Investigational Site
São Paulo - SP, , Brazil
ImClone Investigational Site
Montreal, Quebec, Canada
ImClone Investigational Site
Pula, , Croatia
ImClone Investigational Site
Caen, , France
ImClone Investigational Site
Paris, , France
ImClone Investigational Site
Berlin, , Germany
ImClone Investigational Site
Essen, , Germany
ImClone Investigational Site
Frankfurt, , Germany
ImClone Investigational Site
Gauting, , Germany
ImClone Investigational Site
Großhansdorf, , Germany
ImClone Investigational Site
Halle, , Germany
ImClone Investigational Site
Hamburg, , Germany
ImClone Investigational Site
Heidelberg, , Germany
ImClone Investigational Site
Hemer, , Germany
ImClone Investigational Site
Hofheim, , Germany
ImClone Investigational Site
Karlsruhe, , Germany
ImClone Investigational Site
Lostau, , Germany
ImClone Investigational Site
Löwenstein, , Germany
ImClone Investigational Site
Mainz, , Germany
ImClone Investigational Site
München, , Germany
ImClone Investigational Site
Münster, , Germany
ImClone Investigational Site
Regensburg, , Germany
ImClone Investigational Site
Ulm, , Germany
ImClone Investigational Site
Athens, , Greece
ImClone Investigational Site
Heraklion, Crete, , Greece
ImClone Investigational Site
Pátrai, , Greece
ImClone Investigational Site
Budapest, , Hungary
ImClone Investigational Site
Budapest, , Hungary
ImClone Investigational Site
Deszk, , Hungary
ImClone Investigational Site
Mosonmagyaróvár, , Hungary
ImClone Investigational Site
Székesfehérvár, , Hungary
ImClone Investigational Site
Szombathely, , Hungary
ImClone Investigational Site
Törökbálint, , Hungary
ImClone Investigational Site
Lido di Camaiore, Lucca, Italy
ImClone Investigational Site
Aviano, Pordenone, Italy
ImClone Investigational Site
Frosinone, , Italy
ImClone Investigational Site
Genova, , Italy
ImClone Investigational Site
Milan, , Italy
ImClone Investigational Site
Parma, , Italy
ImClone Investigational Site
Perugia, , Italy
ImClone Investigational Site
Olsztyn, , Poland
ImClone Investigational Site
Otwock, , Poland
ImClone Investigational Site
Poznan, , Poland
ImClone Investigational Site
Radom, , Poland
ImClone Investigational Site
Szczecin, , Poland
ImClone Investigational Site
Wroclaw, , Poland
ImClone Investigational Site
Coimbra, , Portugal
ImClone Investigational Site
Lisbon, , Portugal
ImClone Investigational Site
Brasov, , Romania
ImClone Investigational Site
Bucharest, , Romania
ImClone Investigational Site
Bucharest, , Romania
ImClone Investigational Site
Cluj-Napoca, , Romania
ImClone Investigational Site
Craiova, Dolj, , Romania
ImClone Investigational Site
Iași, , Romania
ImClone Investigational Site
Sibiu, , Romania
ImClone Investigational Site
Ivanovo, , Russia
ImClone Investigational Site
Kirov, , Russia
ImClone Investigational Site
Omsk, , Russia
ImClone Investigational Site
Saint Petersburg, , Russia
ImClone Investigational Site
Saint Petersburg, , Russia
ImClone Investigational Site
Saint Petersburg, , Russia
ImClone Investigational Site
Ufa, , Russia
ImClone Investigational Site
Yaroslavi, , Russia
ImClone Investigational Site
Bratislava, , Slovakia
ImClone Investigational Site
Nitra, , Slovakia
ImClone Investigational Site
Bloemfontein, Free State, South Africa
ImClone Investigational Site
Pretoria, Gauteng, South Africa
Imclone Investigational Site
Seville, Andalusia, Spain
ImClone Investigational Site
Barcelona, Catalonia, Spain
ImClone Investigational Site
Barcelona, Catalonia, Spain
ImClone Investigational Site
Terrassa, Catalonia, Spain
ImClone Investigational Site
Madrid, Communidad de Madrid, Spain
ImClone Investigational Site
Madrid, Communidad de Madrid, Spain
ImClone Investigational Site
Majadahonda, Communidad de Madrid, Spain
ImClone Investigational Site
L'Hospitalet de Llobregat, , Spain
ImClone Investigational Site
Aberdeen, , United Kingdom
ImClone Investigational Site
Bournemouth, , United Kingdom
ImClone Investigational Site
Edinburgh, , United Kingdom
ImClone Investigational Site
Guildford, , United Kingdom
ImClone Investigational Site
Leeds, , United Kingdom
ImClone Investigational Site
Preston, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2009-012574-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP11-0805
Identifier Type: OTHER
Identifier Source: secondary_id
I4X-IE-JFCB
Identifier Type: OTHER
Identifier Source: secondary_id
13908
Identifier Type: -
Identifier Source: org_study_id
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