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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00982111




Registration number
NCT00982111
Ethics application status
Date submitted
18/09/2009
Date registered
22/09/2009

Titles & IDs
Public title
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
Scientific title
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)
Secondary ID [1] 0 0
2009-012574-12
Secondary ID [2] 0 0
13908
Universal Trial Number (UTN)
Trial acronym
INSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Other - Necitumumab

Experimental: Necitumumab + Pemetrexed + Cisplatin - Necitumumab + Pemetrexed + Cisplatin

Active comparator: Pemetrexed + Cisplatin - Pemetrexed + Cisplatin


Treatment: Drugs: 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

Treatment: Drugs: Cisplatin
75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Treatment: Other: Necitumumab
800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Time (OS)
Timepoint [1] 0 0
Randomization to Death from Any Cause (Up to 31.6 Months)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)
Secondary outcome [2] 0 0
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])
Timepoint [2] 0 0
Baseline to Measured Progressive Disease (Up to 30.4 Months)
Secondary outcome [3] 0 0
Time to Treatment Failure (TTF)
Timepoint [3] 0 0
Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Timepoint [4] 0 0
Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks
Secondary outcome [5] 0 0
Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
Timepoint [5] 0 0
Baseline to Study Completion (Up to 31.6 Months)
Secondary outcome [6] 0 0
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)
Timepoint [6] 0 0
Baseline, Cycle 6 (Cycle = 3 weeks)
Secondary outcome [7] 0 0
Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
Timepoint [7] 0 0
Baseline, Cycle 6 (Cycle =3 Weeks)
Secondary outcome [8] 0 0
Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Percentage of Participants With EGFR Measured by IHC
Timepoint [9] 0 0
Baseline

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2020
Sample size
Target
Accrual to date
Final
633
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
ImClone Investigational Site - Kogarah
Recruitment hospital [2] 0 0
ImClone Investigational Site - Hobart
Recruitment hospital [3] 0 0
ImClone Investigational Site - East Bentleigh
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Austria
State/province [2] 0 0
Rankweil
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Duffel
Country [5] 0 0
Belgium
State/province [5] 0 0
Liège
Country [6] 0 0
Belgium
State/province [6] 0 0
Namur
Country [7] 0 0
Brazil
State/province [7] 0 0
Barretos - SP
Country [8] 0 0
Brazil
State/province [8] 0 0
Brasilia, Distrito Federal
Country [9] 0 0
Brazil
State/province [9] 0 0
Goiania - GO
Country [10] 0 0
Brazil
State/province [10] 0 0
Ijui
Country [11] 0 0
Brazil
State/province [11] 0 0
Itajai
Country [12] 0 0
Brazil
State/province [12] 0 0
Lajeado
Country [13] 0 0
Brazil
State/province [13] 0 0
Porto Alegre/RS
Country [14] 0 0
Brazil
State/province [14] 0 0
Ribeirão Preto - SP
Country [15] 0 0
Brazil
State/province [15] 0 0
Salvador
Country [16] 0 0
Brazil
State/province [16] 0 0
Santo Andre - SP
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo - SP
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Croatia
State/province [19] 0 0
Pula
Country [20] 0 0
France
State/province [20] 0 0
Caen
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Essen
Country [24] 0 0
Germany
State/province [24] 0 0
Frankfurt
Country [25] 0 0
Germany
State/province [25] 0 0
Gauting
Country [26] 0 0
Germany
State/province [26] 0 0
Großhansdorf
Country [27] 0 0
Germany
State/province [27] 0 0
Halle
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Heidelberg
Country [30] 0 0
Germany
State/province [30] 0 0
Hemer
Country [31] 0 0
Germany
State/province [31] 0 0
Hofheim
Country [32] 0 0
Germany
State/province [32] 0 0
Karlsruhe
Country [33] 0 0
Germany
State/province [33] 0 0
Lostau
Country [34] 0 0
Germany
State/province [34] 0 0
Löwenstein
Country [35] 0 0
Germany
State/province [35] 0 0
Mainz
Country [36] 0 0
Germany
State/province [36] 0 0
München
Country [37] 0 0
Germany
State/province [37] 0 0
Münster
Country [38] 0 0
Germany
State/province [38] 0 0
Regensburg
Country [39] 0 0
Germany
State/province [39] 0 0
Ulm
Country [40] 0 0
Greece
State/province [40] 0 0
Athens
Country [41] 0 0
Greece
State/province [41] 0 0
Heraklion, Crete
Country [42] 0 0
Greece
State/province [42] 0 0
Patras
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Deszk
Country [45] 0 0
Hungary
State/province [45] 0 0
Mosonmagyaróvár
Country [46] 0 0
Hungary
State/province [46] 0 0
Szombathely
Country [47] 0 0
Hungary
State/province [47] 0 0
Székesfehérvár
Country [48] 0 0
Hungary
State/province [48] 0 0
Törökbálint
Country [49] 0 0
Italy
State/province [49] 0 0
Lucca
Country [50] 0 0
Italy
State/province [50] 0 0
Pordenone
Country [51] 0 0
Italy
State/province [51] 0 0
Frosinone
Country [52] 0 0
Italy
State/province [52] 0 0
Genova
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Parma
Country [55] 0 0
Italy
State/province [55] 0 0
Perugia
Country [56] 0 0
Poland
State/province [56] 0 0
Olsztyn
Country [57] 0 0
Poland
State/province [57] 0 0
Otwock
Country [58] 0 0
Poland
State/province [58] 0 0
Poznan
Country [59] 0 0
Poland
State/province [59] 0 0
Radom
Country [60] 0 0
Poland
State/province [60] 0 0
Szczecin
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Portugal
State/province [62] 0 0
Coimbra
Country [63] 0 0
Portugal
State/province [63] 0 0
Lisboa
Country [64] 0 0
Romania
State/province [64] 0 0
Brasov
Country [65] 0 0
Romania
State/province [65] 0 0
Bucharest
Country [66] 0 0
Romania
State/province [66] 0 0
Cluj-Napoca
Country [67] 0 0
Romania
State/province [67] 0 0
Craiova, Dolj
Country [68] 0 0
Romania
State/province [68] 0 0
Iasi
Country [69] 0 0
Romania
State/province [69] 0 0
Sibiu
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Ivanovo
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Kirov
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Omsk
Country [73] 0 0
Russian Federation
State/province [73] 0 0
St. Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Ufa
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Yaroslavi
Country [76] 0 0
Slovakia
State/province [76] 0 0
Bratislava
Country [77] 0 0
Slovakia
State/province [77] 0 0
Nitra
Country [78] 0 0
South Africa
State/province [78] 0 0
Free State
Country [79] 0 0
South Africa
State/province [79] 0 0
Gauteng
Country [80] 0 0
Spain
State/province [80] 0 0
Andalucia
Country [81] 0 0
Spain
State/province [81] 0 0
Cataluña
Country [82] 0 0
Spain
State/province [82] 0 0
Communidad De Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
L'Hospitalet de Llobregat
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Aberdeen
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Bournemouth
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Edinburgh
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Guildford
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Leeds
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Parexel
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
PPD
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Medidata Solutions
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Laboratory Corporation of America
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Colorado, Denver
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Thermo Fisher Scientific, Inc
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Pacific Biomarkers
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/industry
Name [9] 0 0
Intertek
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Commercial sector/industry
Name [10] 0 0
Sysmex Inostics GmbH
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and assigned data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00982111