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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00981058
Registration number
NCT00981058
Ethics application status
Date submitted
18/09/2009
Date registered
22/09/2009
Date last updated
2/08/2024
Titles & IDs
Public title
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
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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)
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Secondary ID [1]
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CP11-0806
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Secondary ID [2]
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13909
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Universal Trial Number (UTN)
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Trial acronym
SQUIRE
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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: Other - Necitumumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Experimental: Necitumumab + Gemcitabine + Cisplatin -
Active comparator: Gemcitabine + Cisplatin -
Treatment: Other: 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.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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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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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.
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Timepoint [1]
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Randomization to Death from Any Cause (Up to 31 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 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.
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Timepoint [1]
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Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
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Secondary outcome [2]
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Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective 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 31 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 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.
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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 31 Months)
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Secondary outcome [4]
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Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
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Assessment method [4]
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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 [4]
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Baseline, Cycle 6 (Cycle = 3 Weeks)
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Secondary outcome [5]
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Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
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Assessment method [5]
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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 [5]
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Baseline, Cycle 6 (Cycle = 3 Weeks)
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Secondary outcome [6]
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Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
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Assessment method [6]
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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.
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Timepoint [6]
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31 Months
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Secondary outcome [7]
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Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
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Assessment method [7]
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Timepoint [7]
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Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
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Secondary outcome [8]
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Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
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Assessment method [8]
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A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.
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Timepoint [8]
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Baseline through 31 Months
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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
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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 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
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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
7/01/2010
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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
30/05/2024
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Sample size
Target
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Accrual to date
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Final
1093
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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ImClone Investigational Site - Garran
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Recruitment hospital [2]
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ImClone Investigational Site - Westmead
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Recruitment hospital [3]
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ImClone Investigational Site - Wollongong
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Recruitment hospital [4]
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ImClone Investigational Site - East Bentleigh
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Recruitment hospital [5]
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ImClone Investigational Site - Geelong
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2145 - Westmead
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2500 - Wollongong
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Recruitment postcode(s) [4]
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3165 - East Bentleigh
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment outside Australia
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Illinois
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Indiana
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Philippines
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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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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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Szczecin
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Torun
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Poland
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Wroclaw
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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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Brasov
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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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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
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Ufa
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Nitra
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Slovakia
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Poprad
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South Africa
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Free State
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Gauteng
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Kwazulu-Natal
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Andalucía
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Castilla Y Leon
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Cataluña
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L'Hospitalet de Llobregat
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Spain
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Madrid
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United Kingdom
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Dundee
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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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United Kingdom
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London
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Manchester
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United Kingdom
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Preston
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Funding & Sponsors
Primary sponsor type
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Name
Eli Lilly and Company
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Parexel
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PPD
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Medidata Solutions
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Commercial sector/industry
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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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Other
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Thermo Fisher Scientific FS
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ICON Clinical Research
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Other
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Pacific Biomarkers
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Sysmex Inostics GmbH
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Intertek
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00981058
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Trial related presentations / publications
Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafranski W, Ramlau R, Balint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13. Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20. Reck M, Socinski MA, Luft A, Szczesna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12. Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.
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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 scientific queries
No information has been provided regarding IPD availability
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/NCT00981058
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