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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00982111
Registration number
NCT00982111
Ethics application status
Date submitted
18/09/2009
Date registered
22/09/2009
Date last updated
11/01/2022
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
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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)
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Secondary ID [1]
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2009-012574-12
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Secondary ID [2]
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13908
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Universal Trial Number (UTN)
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Trial acronym
INSPIRE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Other interventions - 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
Other interventions: Necitumumab
800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival Time (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization to Death from Any Cause (Up to 31.6 Months)
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
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Timepoint [1]
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Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)
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Secondary outcome [2]
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Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])
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Assessment method [2]
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ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
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Timepoint [2]
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Baseline to Measured Progressive Disease (Up to 30.4 Months)
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Secondary outcome [3]
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Time to Treatment Failure (TTF)
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Assessment method [3]
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TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.
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Timepoint [3]
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Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)
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Secondary outcome [4]
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Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
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Assessment method [4]
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Timepoint [4]
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Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks
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Secondary outcome [5]
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Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
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Assessment method [5]
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A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
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Timepoint [5]
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Baseline to Study Completion (Up to 31.6 Months)
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Secondary outcome [6]
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Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)
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Assessment method [6]
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The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
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Timepoint [6]
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Baseline, Cycle 6 (Cycle = 3 weeks)
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Secondary outcome [7]
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Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)
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Assessment method [7]
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The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
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Timepoint [7]
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Baseline, Cycle 6 (Cycle =3 Weeks)
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Secondary outcome [8]
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Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
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Assessment method [8]
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EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Percentage of Participants With EGFR Measured by IHC
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Assessment method [9]
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EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.
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Timepoint [9]
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Baseline
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/12/2020
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Sample size
Target
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Accrual to date
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Final
633
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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ImClone Investigational Site - Kogarah
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Recruitment hospital [2]
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ImClone Investigational Site - Hobart
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Recruitment hospital [3]
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ImClone Investigational Site - East Bentleigh
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3165 - East Bentleigh
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Austria
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Rankweil
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Austria
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Wien
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Belgium
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Duffel
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Belgium
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Liège
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Belgium
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Namur
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Brazil
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State/province [7]
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Barretos - SP
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Brazil
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Brasilia, Distrito Federal
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Brazil
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Goiania - GO
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Brazil
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Ijui
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Brazil
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Itajai
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Brazil
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Lajeado
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Porto Alegre/RS
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Brazil
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Ribeirão Preto - SP
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Brazil
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Salvador
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Brazil
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Santo Andre - SP
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São Paulo - SP
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Quebec
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Croatia
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Pula
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Caen
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France
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Paris
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Berlin
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Essen
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Frankfurt
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Gauting
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Halle
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Hemer
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Hofheim
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Ulm
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Patras
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Deszk
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Lucca
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Italy
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Genova
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Italy
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Radom
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Craiova, Dolj
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Romania
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Iasi
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Romania
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Sibiu
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Ivanovo
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Omsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Ufa
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Nitra
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South Africa
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South Africa
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Gauteng
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Spain
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Andalucia
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Spain
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Cataluña
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Spain
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Communidad De Madrid
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Spain
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L'Hospitalet de Llobregat
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United Kingdom
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Aberdeen
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United Kingdom
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Bournemouth
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United Kingdom
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Edinburgh
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United Kingdom
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Guildford
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United Kingdom
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Leeds
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United Kingdom
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Preston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Commercial sector/Industry
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Quintiles, Inc.
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Commercial sector/Industry
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Parexel
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PPD
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Medidata Solutions
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Laboratory Corporation of America
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Other
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University of Colorado, Denver
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Thermo Fisher Scientific, Inc
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Other
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Pacific Biomarkers
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Commercial sector/Industry
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Intertek
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Commercial sector/Industry
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Sysmex Inostics GmbH
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00982111
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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)
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Eli Lilly and Company
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00982111
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