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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00981058




Registration number
NCT00981058
Ethics application status
Date submitted
18/09/2009
Date registered
22/09/2009
Date last updated
11/02/2020

Titles & IDs
Public title
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Scientific title
A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
CP11-0806
Secondary ID [2] 0 0
13909
Universal Trial Number (UTN)
Trial acronym
SQUIRE
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
Other interventions - Necitumumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin

Experimental: Necitumumab + Gemcitabine + Cisplatin -

Active Comparator: Gemcitabine + Cisplatin -


Other interventions: Necitumumab
800 milligrams (mg) Intravenously IV infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Treatment: Drugs: Gemcitabine
1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.

Treatment: Drugs: Cisplatin
75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Time (OS) - Overall survival 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 by the Kaplan-Meier method.
Timepoint [1] 0 0
Randomization to Death from Any Cause (Up to 31 Months)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) - PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were 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 participants were 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.
Timepoint [1] 0 0
Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
Secondary outcome [2] 0 0
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR]) - 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.
Timepoint [2] 0 0
Baseline to Measured Progressive Disease (Up to 31 Months)
Secondary outcome [3] 0 0
Time to Treatment Failure (TTF) - TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.
Timepoint [3] 0 0
Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
Secondary outcome [4] 0 0
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D) - 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).
Timepoint [4] 0 0
Baseline, Cycle 6 (Cycle = 3 Weeks)
Secondary outcome [5] 0 0
Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS) - 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.
Timepoint [5] 0 0
Baseline, Cycle 6 (Cycle = 3 Weeks)
Secondary outcome [6] 0 0
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC) - EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess 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.
Timepoint [6] 0 0
31 Months
Secondary outcome [7] 0 0
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Timepoint [7] 0 0
Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
Secondary outcome [8] 0 0
Number of Participants With a Serum Anti-Necitumumab Antibody Assessment - A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.
Timepoint [8] 0 0
Baseline through 31 Months

Eligibility
Key inclusion criteria
- Has histologically or cytologically confirmed squamous NSCLC

- Has Stage IV disease at the time of study entry

- Measurable or nonmeasurable disease at the time of study entry as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (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 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 (failure rate < 1%) 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 participant is 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 pregnancy
test within 7 days prior to randomization

- Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by
PCR) and EGFR gene copy number (by FISH); minimum of four slides, paraffin-embedded
tissue, required
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has nonsquamous NSCLC (adenocarcinoma/large cell or other)

- Has received prior anticancer therapy with monoclonal antibodies, signal transduction
inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor
(VEGF), or VEGF receptor

- Has 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)

- Has undergone major surgery or received any investigational therapy in the 4 weeks
prior to randomization

- Has 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

- Has any National Cancer Institute - Common Terminology Criteria for Adverse Events
(NCI-CTCAE) Version 3.0 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

- Has a known allergy / history of hypersensitivity reaction to any of the treatment
components, including any ingredient used in the formulation of necitumumab
(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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
ImClone Investigational Site - Garran
Recruitment hospital [2] 0 0
ImClone Investigational Site - Westmead
Recruitment hospital [3] 0 0
ImClone Investigational Site - Wollongong
Recruitment hospital [4] 0 0
ImClone Investigational Site - East Bentleigh
Recruitment hospital [5] 0 0
ImClone Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
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United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
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Ohio
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United States of America
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Pennsylvania
Country [14] 0 0
United States of America
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Tennessee
Country [15] 0 0
United States of America
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Virginia
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Austria
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Linz
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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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Liege
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Belgium
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Namur
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Brazil
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Barretos
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Brazil
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Brasilia, Distrito Federal
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Brazil
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Goiania
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Brazil
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Ijui
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Brazil
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Itajai
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Lajeado
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Porto Alegre/RS
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Salvador
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Santo Andre
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Sao Paulo
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São Paulo - SP
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Canada
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New Brunswick
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Ontario
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Canada
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Saskatchewan
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Croatia
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Dubrovnik
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Croatia
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Pula
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Croatia
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Zagreb
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France
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Brest Cedex
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Caen
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Lille
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Lyon
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Marseille
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Paris
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France
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Rennes
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France
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Saint-Jean
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France
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Toulon Armées
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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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Hamburg
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Heidelberg
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Hemer
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Hofheim
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Karlsruhe
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Germany
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Lostau
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Germany
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Löwenstein
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Germany
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München
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Germany
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Münster
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Germany
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Regensburg
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Germany
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Ulm
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Greece
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Athens
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Greece
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Heraklion, Crete
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Deszk
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Hungary
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Farkasgyepü
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Mosonmagyaróvár
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Szombathely
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Hungary
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Székesfehérvár
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Hungary
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Törökbálint
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Italy
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Lucca
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Italy
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Pordenone
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Italy
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Frosinone
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Genova
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Milano
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Italy
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Monza
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Italy
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Parma
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Italy
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Perugia
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Korea, Republic of
State/province [87] 0 0
Incheon
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Korea, Republic of
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Jeonju-si
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Korea, Republic of
State/province [89] 0 0
Seongnam
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Philippines
State/province [92] 0 0
Cebu City
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Philippines
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Cebu
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Philippines
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Davao City
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Philippines
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Makati City
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Olsztyn
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Otwock
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Poland
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Poznan
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Poland
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Radom
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Poland
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Rzeszow
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Poland
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Szczecin
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Poland
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Torun
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Poland
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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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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Piatra Neamt
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Romania
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Sibiu
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Russian Federation
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Ivanovo
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Russian Federation
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Kirov
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
State/province [123] 0 0
Ufa
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Russian Federation
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Yaroslavl
Country [125] 0 0
Serbia
State/province [125] 0 0
Belgrade
Country [126] 0 0
Serbia
State/province [126] 0 0
Kragujevac
Country [127] 0 0
Serbia
State/province [127] 0 0
Nis
Country [128] 0 0
Serbia
State/province [128] 0 0
Sremska Kamenica
Country [129] 0 0
Singapore
State/province [129] 0 0
Singapore
Country [130] 0 0
Slovakia
State/province [130] 0 0
Bratislava
Country [131] 0 0
Slovakia
State/province [131] 0 0
Nitra
Country [132] 0 0
Slovakia
State/province [132] 0 0
Poprad
Country [133] 0 0
South Africa
State/province [133] 0 0
Free State
Country [134] 0 0
South Africa
State/province [134] 0 0
Gauteng
Country [135] 0 0
South Africa
State/province [135] 0 0
Kwazulu-Natal
Country [136] 0 0
Spain
State/province [136] 0 0
Andalucía
Country [137] 0 0
Spain
State/province [137] 0 0
Castilla Y Leon
Country [138] 0 0
Spain
State/province [138] 0 0
Cataluña
Country [139] 0 0
Spain
State/province [139] 0 0
Communidad De Madrid
Country [140] 0 0
Spain
State/province [140] 0 0
Barcelona
Country [141] 0 0
Spain
State/province [141] 0 0
L'Hospitalet de Llobregat
Country [142] 0 0
Spain
State/province [142] 0 0
Madrid
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taichung
Country [144] 0 0
Thailand
State/province [144] 0 0
Chiang Mai
Country [145] 0 0
Thailand
State/province [145] 0 0
Songkhla
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Aberdeen
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Bournemouth
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Dundee
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Edinburgh
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Guildford
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Liverpool
Country [152] 0 0
United Kingdom
State/province [152] 0 0
London
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Manchester
Country [154] 0 0
United Kingdom
State/province [154] 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
Parexel
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
PPD
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Medidata Solutions
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Laboratory Corporation of America
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Colorado, Denver
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Thermo Fisher Scientific
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/Industry
Name [7] 0 0
ICON Clinical Research
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
Sysmex Inostics GmbH
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Commercial sector/Industry
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Intertek
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Ethics approval
Ethics application status

Summary
Brief summary
The research study is testing the investigational drug necitumumab (IMC-11F8) 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 gemcitabine will be more effective in improving participant disease than the standard
chemotherapy combination alone.
Trial website
https://clinicaltrials.gov/show/NCT00981058
Trial related presentations / publications
Public notes

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)
Address 0 0
Eli Lilly and Company
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Phone 0 0
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Email 0 0
Contact person for public queries
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Email 0 0
Contact person for scientific queries

Summary results
Other publications