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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00806819




Registration number
NCT00806819
Ethics application status
Date submitted
10/12/2008
Date registered
11/12/2008
Date last updated
2/02/2017

Titles & IDs
Public title
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
Scientific title
Multicenter, Randomized, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Pemetrexed Therapy Compared to Placebo Plus Standard Pemetrexed Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
Secondary ID [1] 0 0
2008-002072-10
Secondary ID [2] 0 0
1199.14
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nintedanib (BIBF1120)
Treatment: Drugs - Pemetrexed
Treatment: Drugs - pemetrexed
Treatment: Drugs - B12
Treatment: Drugs - dexamethasone (or corticosteroid equivalent)
Treatment: Drugs - placebo
Treatment: Drugs - dexamethasone (or corticosteroid equivalent)
Treatment: Drugs - B12
Treatment: Drugs - Folic Acid
Treatment: Drugs - B12
Treatment: Drugs - dexamethasone (or corticosteroid equivalent)
Treatment: Drugs - Folic Acid
Treatment: Drugs - placebo
Treatment: Drugs - Folic Acid
Treatment: Drugs - Nintedanib (BIBF1120)
Treatment: Drugs - Pemetrexed

Experimental: nintedanib (BIBF1120) plus pemetrexed - nintedanib (BIBF1120) along with standard therapy of pemetrexed

Placebo Comparator: Placebo plus pemetrexed - Pemetrexed standard therapy

Experimental: nintedanib (BIBF1120) monotherapy - nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed

Active Comparator: pemetrexed monotherapy - pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo

Placebo Comparator: placebo monotherapy - placebo monotherapy only for patients who discontinue pemetrexed


Treatment: Drugs: Nintedanib (BIBF1120)
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.

Treatment: Drugs: Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

Treatment: Drugs: pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

Treatment: Drugs: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Treatment: Drugs: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Treatment: Drugs: placebo
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.

Treatment: Drugs: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Treatment: Drugs: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Treatment: Drugs: Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.

Treatment: Drugs: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Treatment: Drugs: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Treatment: Drugs: Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.

Treatment: Drugs: placebo
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.

Treatment: Drugs: Folic Acid
400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed.

Treatment: Drugs: Nintedanib (BIBF1120)
starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.

Treatment: Drugs: Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

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

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by Central Independent Review - Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Timepoint [1] 0 0
From randomisation until cut-off date 9 July 2012
Secondary outcome [1] 0 0
Overall Survival (Key Secondary Endpoint) - Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Timepoint [1] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [2] 0 0
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review - Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Timepoint [2] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [3] 0 0
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator - Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Timepoint [3] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [4] 0 0
Objective Tumor Response - Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator
Timepoint [4] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [5] 0 0
Duration of Confirmed Objective Tumour Response - The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator.
Timepoint [5] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [6] 0 0
Time to Confirmed Objective Tumour Response - Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator.
Timepoint [6] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [7] 0 0
Disease Control - Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.
This endpoint was analysed based on the central independent reviewer as well as the investigator.
Timepoint [7] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [8] 0 0
Duration of Disease Control - The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator.
Timepoint [8] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [9] 0 0
Change From Baseline in Tumour Size - Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.
Timepoint [9] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [10] 0 0
Clinical Improvement. - Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Timepoint [10] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [11] 0 0
Quality of Life (QoL) - QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Timepoint [11] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [12] 0 0
Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide - Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.
Timepoint [12] 0 0
Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3
Secondary outcome [13] 0 0
Incidence and Intensity of Adverse Events - Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.
Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint.
Timepoint [13] 0 0
From the first drug administration until 28 days after the last drug administration, up to 36 months

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male or female patient aged 18 years or older.

2. Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or
recurrent non small cell lung cancer (NSCLC) (non squamous histologies)

3. Relapse or failure of one first line chemotherapy (in the case of recurrent disease
one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus
adjuvant therapy).

4. At least one target tumor lesion that has not been irradiated within the past three
months and that can accurately be measured by magnetic resonance imaging (MRI) or
computed tomography (CT) in at least one dimension (longest diameter to be recorded)
as greater than or equal to 20 mm with conventional techniques or as greater than or
equal to 10 mm with spiral CT.

5. Life expectancy of at least three months.

6. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

7. Patient has given written informed consent which must be consistent with the
International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local
legislation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Previous therapy with other vascular endothelial growth factor (VEGF) inhibitors
(other than bevacizumab) or pemetrexed for treatment of NSCLC

2. Treatment with other investigational drugs or treatment in another clinical trial
within the past four weeks before start of therapy or concomitantly with this trial

3. Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment
with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities)
within the past four weeks prior to treatment with the trial drug, i.e., the minimum
time elapsed since the last anticancer therapy and the first administration of BIBF
1120 must be four weeks

4. Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several
days

5. Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with
radiotherapy, symptomatic, requiring treatment with anti-convulsants). Dexamethasone
therapy will be allowed if administered as stable dose for at least one month before
randomisation)

6. Radiographic evidence of cavitary or necrotic tumors

7. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of
major blood vessels

8. History of clinically significant haemoptysis within the past 3 months

9. Therapeutic anticoagulation

10. History of major thrombotic or clinically relevant major bleeding event in the past 6
months

11. Significant cardiovascular diseases (i.e., hypertension not controlled by medical
therapy, unstable angina, history of myocardial infarction within the past 6 months,

12. Inadequate kidney, liver, blood clotting function

13. Inadequate blood count

14. Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the
present trial

15. Current peripheral neuropathy greater than or equal to Common Terminology Criteria for
Adverse Events (CTCAE) Grade 2 except due to trauma

16. Pre-existing ascites (abdominal fluid collection) and/or clinically significant
pleural effusion ( fluid collection between the lung and chest wall)

17. Major injuries and/or surgery within the past ten days prior to start of study drug

18. Incomplete wound healing

19. Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply

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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
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,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Sydney
Recruitment hospital [2] 0 0
Boehringer Ingelheim Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [5] 0 0
Boehringer Ingelheim Investigational Site - Melbourne
Recruitment hospital [6] 0 0
Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Toorak Gardens
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Nebraska
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
Country [18] 0 0
United States of America
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Washington
Country [19] 0 0
United States of America
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Wisconsin
Country [20] 0 0
Argentina
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Bs. As. Codigo Buenos Aires
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Argentina
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Córdoba
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Argentina
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Pergamino
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Argentina
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Quilmes Buenos Aires
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Argentina
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Rosario, Santa Fe
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Argentina
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San Miguel de Tucuman
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Argentina
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San Miguel de Tucumán
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Bosnia and Herzegovina
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Banja Luka
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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Belo Horizonte,Minas Gerais
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Brazil
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Belo Horizonte
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Brazil
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Cachoeira do Itapemirim-ES
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Brazil
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Campinas SP
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Brazil
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Caxias do Sul
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Curitiba
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Florianopolis
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Goiania Goias
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Ijui
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Itajai
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Londrina, Parana
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Pelotas Rio Grande do Sul
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Porto Alegre
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Rio de Janeiro
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Salvador Bahia
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Santo Andre, Sao Paulo
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Santo Andre
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Sao Paulo - SP
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Santiago
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Chile
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Temuco
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Colombia
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Ecuador
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Cuenca
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Quito
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Augsburg
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Berlin
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Gauting
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Halle (Saale)
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Germany
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Hemer
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München
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Hong Kong
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Hungary
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Deszk
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Hungary
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Nyíregyháza
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Hungary
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Pécs
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Ireland
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Dublin 8
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejoen
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Korea, Republic of
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Gangdong-gu, Seoul
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeonbuk
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Seochogu, Seoul
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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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Latvia
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Daugavpils
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Latvia
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Liepaja
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Latvia
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Riga
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Macedonia, The Former Yugoslav Republic of
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Bitola
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Macedonia, The Former Yugoslav Republic of
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Skopje
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Malaysia
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Georgetown
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Malaysia
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Kota Kinabalu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Penang
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Mexico
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Chihuahua
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Mexico
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Morelia
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Moldova, Republic of
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Chisinau
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Netherlands
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Hertogenbosch
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Palmerston North
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New Zealand
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Wellington
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Panama
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Carrasquilla Panama
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Panama
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Panama
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Peru
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Arequipa
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Peru
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Cercado Arequipa
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Peru
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Lima
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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
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Philippines
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Quezon
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Poland
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Olsztyn
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Romania
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Baia Mare
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Iasi
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Romania
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Onesti
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Romania
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Timisoara
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Sweden
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Gävle
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Sweden
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Stockholm
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Sweden
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Umeå
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
Country [121] 0 0
Taiwan
State/province [121] 0 0
Tainan City
Country [122] 0 0
Taiwan
State/province [122] 0 0
Tainan
Country [123] 0 0
Taiwan
State/province [123] 0 0
Taipei
Country [124] 0 0
Thailand
State/province [124] 0 0
Bangkok
Country [125] 0 0
Thailand
State/province [125] 0 0
Chiang Mai
Country [126] 0 0
Turkey
State/province [126] 0 0
Ankara
Country [127] 0 0
Turkey
State/province [127] 0 0
Antalya
Country [128] 0 0
Turkey
State/province [128] 0 0
Aydin
Country [129] 0 0
Turkey
State/province [129] 0 0
Balcali-Adana
Country [130] 0 0
Turkey
State/province [130] 0 0
Diyarbakir
Country [131] 0 0
Turkey
State/province [131] 0 0
Gaziantep
Country [132] 0 0
Turkey
State/province [132] 0 0
Kocaeli
Country [133] 0 0
Ukraine
State/province [133] 0 0
Chernigiv
Country [134] 0 0
Ukraine
State/province [134] 0 0
Dnipropetrovks
Country [135] 0 0
Ukraine
State/province [135] 0 0
Kharkiv
Country [136] 0 0
Ukraine
State/province [136] 0 0
Uzhgorod
Country [137] 0 0
Ukraine
State/province [137] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed
therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in
patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed
will be obtained.
Trial website
https://clinicaltrials.gov/show/NCT00806819
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications