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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/NCT00596830
Registration number
NCT00596830
Ethics application status
Date submitted
3/01/2008
Date registered
17/01/2008
Date last updated
13/01/2014
Titles & IDs
Public title
Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
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Scientific title
Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
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Secondary ID [1]
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A4021016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Squamous Cell
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0
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Carcinoma, Adenosquamous
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Carcinoma, Large Cell
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Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Lung - Non small cell
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-751,871 (Figitumumab)
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Experimental: A - Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
Active Comparator: B - Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
Treatment: Drugs: CP-751,871 (Figitumumab)
CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
Treatment: Drugs: Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
Treatment: Drugs: Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
Treatment: Drugs: Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
Treatment: Drugs: Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
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Intervention code [1]
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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 (OS)
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Assessment method [1]
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Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
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Timepoint [1]
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Baseline until death, assessed monthly after end of treatment, up to 30 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 was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).
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Timepoint [1]
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At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.
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Secondary outcome [2]
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Percentage of Participants With Objective Response (OR)
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Assessment method [2]
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Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as =30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.
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Timepoint [2]
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At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months
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Secondary outcome [3]
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European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [3]
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
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Timepoint [3]
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Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
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Secondary outcome [4]
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European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
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Assessment method [4]
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QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
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Timepoint [4]
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Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
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Secondary outcome [5]
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Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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Assessment method [5]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.
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Timepoint [5]
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Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
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Secondary outcome [6]
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Maximum Observed Plasma Concentration (Cmax) for Figitumumab
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Assessment method [6]
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Timepoint [6]
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Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
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Secondary outcome [7]
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Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab
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Assessment method [7]
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Timepoint [7]
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Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
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Secondary outcome [8]
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Number of Participants With Total Anti-drug Antibodies (ADA)
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Assessment method [8]
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ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.
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Timepoint [8]
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Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose
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Secondary outcome [9]
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Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels
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Assessment method [9]
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Timepoint [9]
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Cycles 1 and 4 (predose) and at end of treatment
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of non small cell lung cancer with a primary histology of
predominantly squamous cell, large cell or adenosquamous carcinoma.
- Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or
recurrent disease.
- No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant
chemotherapy must have completed for greater than or equal to 12 months prior to
randomization.
- Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to
randomization and all acute toxicities have resolved.
- ECOG performance status (PS) 0 or 1.
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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
- Patients with symptomatic central nervous system (CNS) metastases are not permitted.
- Patients requiring chronic steroid use or patients with uncontrolled diabetes are not
permitted.
- Patients with other active cancer types are not permitted.
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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
Terminated
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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
1/04/2008
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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
1/09/2012
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Sample size
Target
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Accrual to date
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Final
681
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Albury
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Recruitment hospital [2]
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Pfizer Investigational Site - Port Macquarie
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Recruitment hospital [3]
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Pfizer Investigational Site - Geelong
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Recruitment hospital [4]
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Pfizer Investigational Site - Wodonga
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2444 - Port Macquarie
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3690 - Wodonga
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Recruitment outside Australia
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Alabama
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Genova
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Italy
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Orbassano (TO)
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Italy
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Padova
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Italy
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Roma
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Gyeonggi-do
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Seoul
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Poland
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Gdansk
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Krakow
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Ponce
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Moscow
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Russian Federation
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State/province [102]
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Sochi
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Country [103]
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Russian Federation
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State/province [103]
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0
St-Petersburg
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Country [104]
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Russian Federation
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State/province [104]
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St. Petersburg
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Country [105]
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Slovakia
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State/province [105]
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Nitra-Zobor
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Country [106]
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Slovakia
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State/province [106]
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Nove Zamky
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Country [107]
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Slovakia
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State/province [107]
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Poprad
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Country [108]
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Spain
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State/province [108]
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Barcelona
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Country [109]
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Spain
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State/province [109]
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Cantabria
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Country [110]
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Spain
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State/province [110]
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Navarra
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Country [111]
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Spain
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State/province [111]
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Cordoba
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Country [112]
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Spain
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State/province [112]
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Madrid
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Country [113]
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Spain
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State/province [113]
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Valencia
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Country [114]
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Switzerland
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State/province [114]
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Fribourg
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Country [115]
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Switzerland
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State/province [115]
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Zuerich
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Country [116]
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Taiwan
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State/province [116]
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Kaohsiung Hsien
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Taiwan
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State/province [117]
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Tainan
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Country [118]
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Taiwan
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State/province [118]
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Taipei
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Country [119]
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Turkey
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State/province [119]
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Adana
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Country [120]
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Turkey
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State/province [120]
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Ankara
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Country [121]
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Ukraine
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State/province [121]
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Dnipropetrovsk
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Country [122]
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Ukraine
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State/province [122]
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Donetsk
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Country [123]
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Ukraine
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Kyiv
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Country [124]
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Ukraine
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State/province [124]
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Lviv
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Country [125]
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Ukraine
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Sumy
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Ethics approval
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Summary
Brief summary
Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin
prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or
metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00596830
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00596830
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