Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lume Lung 2 : Nintedanib Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00806819
First received: December 10, 2008
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

The trial will be performed to evaluate if Nintedanib 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 Nintedanib/pemetrexed will be obtained.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Pemetrexed
Drug: Folic Acid
Drug: Nintedanib
Drug: Nintedanib plus pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Multicenter Phase III Trial of Nintedanib Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer Patients After Failure of First Line Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression Free Survival (PFS) as Assessed by Central Independent Review [ Time Frame: From randomisation until cut-off date 9 July 2012 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Overall Survival (Key Secondary Endpoint) [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]
    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.

  • Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]
    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.

  • Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]
    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.

  • Objective Tumor Response [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]
    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

  • Duration of Confirmed Objective Tumour Response [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]

    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.


  • Time to Confirmed Objective Tumour Response [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]

    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.


  • Disease Control [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]

    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.


  • Duration of Disease Control [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in Tumour Size [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]
    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.

  • Clinical Improvement. [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]

    Clinical improvement was defined as the time from 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


  • Quality of Life (QoL) [ Time Frame: From randomisation until cut-off date 15 February 2013 ] [ Designated as safety issue: No ]

    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.


  • Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Incidence and Intensity of Adverse Events [ Time Frame: From the first drug administration until 28 days after the last drug administration, up to 36 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 718
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nintedanib plus pemetrexed
Nintedanib along with standard therapy of pemetrexed
Drug: 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.
Drug: Nintedanib Drug: Nintedanib plus pemetrexed
Active Comparator: Pemetrexed
Pemetrexed standard therapy
Drug: Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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. 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.

Exclusion criteria:

  1. Previous therapy with other 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 brain and 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 Nintedanib 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806819

  Hide Study Locations
Locations
United States, California
1199.14.1092 Boehringer Ingelheim Investigational Site
Downy, California, United States
1199.14.1093 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
1199.14.1164 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
1199.14.1181 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
United States, Connecticut
1199.14.1080 Boehringer Ingelheim Investigational Site
Meriden, Connecticut, United States
United States, Florida
1199.14.1199 Boehringer Ingelheim Investigational Site
Aventura, Florida, United States
1199.14.1194 Boehringer Ingelheim Investigational Site
Boynton Beach, Florida, United States
1199.14.1160 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1199.14.1061 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1199.14.1057 Boehringer Ingelheim Investigational Site
New Port Richey, Florida, United States
1199.14.1054 Boehringer Ingelheim Investigational Site
Port St. Lucie, Florida, United States
1199.14.1055 Boehringer Ingelheim Investigational Site
Stuart, Florida, United States
United States, Illinois
1199.14.1188 Boehringer Ingelheim Investigational Site
Galesburg, Illinois, United States
1199.14.1261 Boehringer Ingelheim Investigational Site
Skokie, Illinois, United States
United States, Indiana
1199.14.1152 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
1199.14.1196 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
1199.14.1058 Boehringer Ingelheim Investigational Site
New Albany, Indiana, United States
United States, Kansas
1199.14.1097 Boehringer Ingelheim Investigational Site
Witchita, Kansas, United States
United States, Kentucky
1199.14.1079 Boehringer Ingelheim Investigational Site
Ashland, Kentucky, United States
1199.14.1172 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Massachusetts
1199.14.1051 Boehringer Ingelheim Investigational Site
Burlington, Massachusetts, United States
1199.14.1182 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Minnesota
1199.14.1098 Boehringer Ingelheim Investigational Site
St. Louis park, Minnesota, United States
United States, Nebraska
1199.14.1086 Boehringer Ingelheim Investigational Site
Grand Island, Nebraska, United States
United States, New Mexico
1199.14.1094 Boehringer Ingelheim Investigational Site
Farmington, New Mexico, United States
United States, New York
1199.14.1165 Boehringer Ingelheim Investigational Site
Dunkirk, New York, United States
1199.14.1099 Boehringer Ingelheim Investigational Site
Goshen, New York, United States
1199.14.1256 Boehringer Ingelheim Investigational Site
Lake Success, New York, United States
1199.14.1151 Boehringer Ingelheim Investigational Site
Nyack, New York, United States
United States, North Carolina
1199.14.1254 Boehringer Ingelheim Investigational Site
Asheville, North Carolina, United States
United States, Ohio
1199.14.1174 Boehringer Ingelheim Investigational Site
Canton, Ohio, United States
1199.14.1071 Boehringer Ingelheim Investigational Site
Sandusky, Ohio, United States
United States, Pennsylvania
1199.14.1179 Boehringer Ingelheim Investigational Site
Ephrata, Pennsylvania, United States
1199.14.1065 Boehringer Ingelheim Investigational Site
Langhorne, Pennsylvania, United States
1199.14.1169 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
1199.14.1056 Boehringer Ingelheim Investigational Site
Germantown, Tennessee, United States
United States, Texas
1199.14.1096 Boehringer Ingelheim Investigational Site
Amarillo, Texas, United States
United States, Washington
1199.14.1158 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
1199.14.1259 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
United States, Wisconsin
1199.14.1186 Boehringer Ingelheim Investigational Site
Madison, Wisconsin, United States
1199.14.1088 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
Argentina
1199.14.2061 Boehringer Ingelheim Investigational Site
Bs. As. Codigo Buenos Aires, Argentina
1199.14.2052 Boehringer Ingelheim Investigational Site
Córdoba, Argentina
1199.14.2062 Boehringer Ingelheim Investigational Site
Pergamino, Argentina
1199.14.2067 Boehringer Ingelheim Investigational Site
Quilmes Buenos Aires, Argentina
1199.14.2068 Boehringer Ingelheim Investigational Site
Rosario, Santa Fe, Argentina
1199.14.2055 Boehringer Ingelheim Investigational Site
San Miguel de Tucuman, Argentina
1199.14.2056 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán, Argentina
Australia, New South Wales
1199.14.8056 Boehringer Ingelheim Investigational Site
Sydney, New South Wales, Australia
Australia, Queensland
1199.14.8057 Boehringer Ingelheim Investigational Site
Brisbane, Queensland, Australia
Australia, South Australia
1199.14.8053 Boehringer Ingelheim Investigational Site
Adelaide, South Australia, Australia
1199.14.8051 Boehringer Ingelheim Investigational Site
Toorak Gardens, South Australia, Australia
Australia, Victoria
1199.14.8054 Boehringer Ingelheim Investigational Site
Melbourne, Victoria, Australia
Australia, Western Australia
1199.14.8055 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
Australia
1199.14.8059 Boehringer Ingelheim Investigational Site
Sydney, Australia
Bosnia and Herzegovina
1199.14.7151 Boehringer Ingelheim Investigational Site
Banja Luka, Bosnia and Herzegovina
1199.14.7152 Boehringer Ingelheim Investigational Site
Sarajevo, Bosnia and Herzegovina
Brazil
1199.14.2161 Boehringer Ingelheim Investigational Site
Belo Horizonte, Brazil
1199.14.2183 Boehringer Ingelheim Investigational Site
Belo Horizonte, Brazil
1199.14.2176 Boehringer Ingelheim Investigational Site
Belo Horizonte,Minas Gerais, Brazil
1199.14.2185 Boehringer Ingelheim Investigational Site
Cachoeira do Itapemirim-ES, Brazil
1199.14.2182 Boehringer Ingelheim Investigational Site
Campinas SP, Brazil
1199.14.2156 Boehringer Ingelheim Investigational Site
Caxias do Sul, Brazil
1199.14.2165 Boehringer Ingelheim Investigational Site
Curitiba, Brazil
1199.14.2154 Boehringer Ingelheim Investigational Site
Florianopolis, Brazil
1199.14.2173 Boehringer Ingelheim Investigational Site
Goiania Goias, Brazil
1199.14.2157 Boehringer Ingelheim Investigational Site
Ijui, Brazil
1199.14.2158 Boehringer Ingelheim Investigational Site
Itajai, Brazil
1199.14.2159 Boehringer Ingelheim Investigational Site
Jau/SP, Brazil
1199.14.2177 Boehringer Ingelheim Investigational Site
Londrina, Parana, Brazil
1199.14.2171 Boehringer Ingelheim Investigational Site
Pelotas Rio Grande do Sul, Brazil
1199.14.2160 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1199.14.2166 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1199.14.2167 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1199.14.2164 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1199.14.2151 Boehringer Ingelheim Investigational Site
Salvador Bahia, Brazil
1199.14.2178 Boehringer Ingelheim Investigational Site
Santo Andre, Brazil
1199.14.2170 Boehringer Ingelheim Investigational Site
Santo Andre, Sao Paulo, Brazil
1199.14.2180 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1199.14.2181 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1199.14.2155 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1199.14.2162 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1199.14.2168 Boehringer Ingelheim Investigational Site
Sao Paulo - SP, Brazil
1199.14.2172 Boehringer Ingelheim Investigational Site
Sorocaba Sao Paulo, Brazil
Canada, Ontario
1199.14.1554 Boehringer Ingelheim Investigational Site
Thunder Bay, Ontario, Canada
1199.14.1556 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1199.14.1557 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1199.14.1558 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1199.14.1553 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Canada
1199.14.1552 Boehringer Ingelheim Investigational Site
Quebec, Canada
Chile
1199.14.2259 Boehringer Ingelheim Investigational Site
Jardin del Mar, Renaca, Chile
1199.14.2254 Boehringer Ingelheim Investigational Site
Las Condes, Chile
1199.14.2251 Boehringer Ingelheim Investigational Site
Santiago, Chile
1199.14.2253 Boehringer Ingelheim Investigational Site
Santiago, Chile
1199.14.2256 Boehringer Ingelheim Investigational Site
Temuco, Chile
Colombia
1199.14.2352 Boehringer Ingelheim Investigational Site
Monteria, Cordoba, Colombia
Ecuador
1199.14.3252 Boehringer Ingelheim Investigational Site
Cuenca, Ecuador
1199.14.3255 Boehringer Ingelheim Investigational Site
Quito, Ecuador
Germany
1199.14.4554 Boehringer Ingelheim Investigational Site
Augsburg, Germany
1199.14.4551 Boehringer Ingelheim Investigational Site
Berlin, Germany
1199.14.4555 Boehringer Ingelheim Investigational Site
Gauting, Germany
1199.14.4552 Boehringer Ingelheim Investigational Site
Halle (Saale), Germany
1199.14.4567 Boehringer Ingelheim Investigational Site
Hemer, Germany
1199.14.4553 Boehringer Ingelheim Investigational Site
München, Germany
Hong Kong
1199.14.8251 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1199.14.8252 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1199.14.8253 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1199.14.8255 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
Hungary
1199.14.7251 Boehringer Ingelheim Investigational Site
Deszk, Hungary
1199.14.7252 Boehringer Ingelheim Investigational Site
Nyíregyháza, Hungary
1199.14.7253 Boehringer Ingelheim Investigational Site
Pécs, Hungary
Ireland
1199.14.7351 Boehringer Ingelheim Investigational Site
Dublin 8, Ireland
Korea, Republic of
1199.14.8563 Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
1199.14.8557 Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
1199.14.8562 Boehringer Ingelheim Investigational Site
Daejoen, Korea, Republic of
1199.14.8560 Boehringer Ingelheim Investigational Site
Gangdong-gu, Seoul, Korea, Republic of
1199.14.8556 Boehringer Ingelheim Investigational Site
Gyeonggi-do, Korea, Republic of
1199.14.8551 Boehringer Ingelheim Investigational Site
Gyeonggi-do, Korea, Republic of
1199.14.8552 Boehringer Ingelheim Investigational Site
Gyeonggi-do, Korea, Republic of
1199.14.8565 Boehringer Ingelheim Investigational Site
Jeonbuk, Korea, Republic of
1199.14.8561 Boehringer Ingelheim Investigational Site
Seochogu, Seoul, Korea, Republic of
1199.14.8559 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.14.8553 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.14.8554 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.14.8558 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.14.8555 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.14.8564 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
Latvia
1199.14.7451 Boehringer Ingelheim Investigational Site
Daugavpils, Latvia
1199.14.7452 Boehringer Ingelheim Investigational Site
Liepaja, Latvia
1199.14.7453 Boehringer Ingelheim Investigational Site
Riga, Latvia
Macedonia, The Former Yugoslav Republic of
1199.14.7552 Boehringer Ingelheim Investigational Site
Bitola, Macedonia, The Former Yugoslav Republic of
1199.14.7553 Boehringer Ingelheim Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of
1199.14.7554 Boehringer Ingelheim Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of
Malaysia
1199.14.8653 Boehringer Ingelheim Investigational Site
Georgetown, Malaysia
1199.14.8654 Boehringer Ingelheim Investigational Site
Kota Kinabalu, Malaysia
1199.14.8651 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
1199.14.8652 Boehringer Ingelheim Investigational Site
Kuching, Malaysia
1199.14.8655 Boehringer Ingelheim Investigational Site
Penang, Malaysia
1199.14.8656 Boehringer Ingelheim Investigational Site
Penang, Malaysia
Mexico
1199.14.2754 Boehringer Ingelheim Investigational Site
Chihuahua, Mexico
1199.14.2752 Boehringer Ingelheim Investigational Site
Morelia, Mexico
Moldova, Republic of
1199.14.7651 Boehringer Ingelheim Investigational Site
Chisinau, Moldova, Republic of
Netherlands
1199.14.7752 Boehringer Ingelheim Investigational Site
Hertogenbosch, Netherlands
New Zealand
1199.14.8753 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1199.14.8751 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
1199.14.8754 Boehringer Ingelheim Investigational Site
Palmerston North, New Zealand
1199.14.8752 Boehringer Ingelheim Investigational Site
Wellington, New Zealand
Panama
1199.14.2852 Boehringer Ingelheim Investigational Site
Carrasquilla Panama, Panama
1199.14.2853 Boehringer Ingelheim Investigational Site
Panama, Panama
Peru
1199.14.2958 Boehringer Ingelheim Investigational Site
Arequipa, Peru
1199.14.2952 Boehringer Ingelheim Investigational Site
Cercado Arequipa, Peru
1199.14.2951 Boehringer Ingelheim Investigational Site
Lima, Peru
1199.14.2953 Boehringer Ingelheim Investigational Site
Lima, Peru
1199.14.2954 Boehringer Ingelheim Investigational Site
Lima, Peru
1199.14.2955 Boehringer Ingelheim Investigational Site
Lima, Peru
1199.14.2956 Boehringer Ingelheim Investigational Site
Lima, Peru
1199.14.2959 Boehringer Ingelheim Investigational Site
Lima, Peru
Philippines
1199.14.8854 Boehringer Ingelheim Investigational Site
Cebu, Philippines
1199.14.8856 Boehringer Ingelheim Investigational Site
Davao City, Philippines
1199.14.8853 Boehringer Ingelheim Investigational Site
Makati, Philippines
1199.14.8851 Boehringer Ingelheim Investigational Site
Quezon, Philippines
1199.14.8852 Boehringer Ingelheim Investigational Site
Quezon, Philippines
Poland
1199.14.6651 Boehringer Ingelheim Investigational Site
Olsztyn, Poland
Romania
1199.14.6753 Boehringer Ingelheim Investigational Site
Baia Mare, Romania
1199.14.6752 Boehringer Ingelheim Investigational Site
Bucuresti, Romania
1199.14.6751 Boehringer Ingelheim Investigational Site
Cluj-Napoca, Romania
1199.14.6756 Boehringer Ingelheim Investigational Site
Iasi, Romania
1199.14.6754 Boehringer Ingelheim Investigational Site
Onesti, Romania
1199.14.6755 Boehringer Ingelheim Investigational Site
Timisoara, Romania
Serbia
1199.14.7851 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1199.14.7852 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1199.14.7853 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1199.14.7855 Boehringer Ingelheim Investigational Site
Nis, Serbia
1199.14.7854 Boehringer Ingelheim Investigational Site
Sremska Kamenica, Serbia
Sweden
1199.14.7052 Boehringer Ingelheim Investigational Site
Gävle, Sweden
1199.14.7054 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1199.14.7055 Boehringer Ingelheim Investigational Site
Umeå, Sweden
1199.14.7053 Boehringer Ingelheim Investigational Site
Uppsala, Sweden
Taiwan
1199.14.9057 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
1199.14.9062 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1199.14.9054 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1199.14.9055 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1199.14.9056 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1199.14.9053 Boehringer Ingelheim Investigational Site
Tainan City, Taiwan
1199.14.9051 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1199.14.9052 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1199.14.9061 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Thailand
1199.14.9152 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1199.14.9153 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1199.14.9154 Boehringer Ingelheim Investigational Site
Chiang Mai, Thailand
Turkey
1199.14.7951 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1199.14.7963 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1199.14.7956 Boehringer Ingelheim Investigational Site
Antalya, Turkey
1199.14.7961 Boehringer Ingelheim Investigational Site
Aydin, Turkey
1199.14.7953 Boehringer Ingelheim Investigational Site
Balcali-Adana, Turkey
1199.14.7957 Boehringer Ingelheim Investigational Site
Diyarbakir, Turkey
1199.14.7958 Boehringer Ingelheim Investigational Site
Gaziantep, Turkey
1199.14.7960 Boehringer Ingelheim Investigational Site
Kocaeli, Turkey
Ukraine
1199.14.6955 Boehringer Ingelheim Investigational Site
Chernigiv, Ukraine
1199.14.6953 Boehringer Ingelheim Investigational Site
Dnipropetrovks, Ukraine
1199.14.6951 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1199.14.6958 Boehringer Ingelheim Investigational Site
Uzhgorod, Ukraine
1199.14.6956 Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00806819     History of Changes
Other Study ID Numbers: 1199.14, 2008-002072-10
Study First Received: December 10, 2008
Results First Received: November 14, 2014
Last Updated: November 14, 2014
Health Authority: Argentina: Ministry of Health
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Bosnia: Federal Ministry of Health
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ecuador: Public Health Ministry
Germany: Ministry of Health
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Korea: Food and Drug Administration
Latvia: State Agency of Medicines
Macedonia: Ministry of Health
Malaysia: Ministry of Health
Mexico: Ministry of Health
Moldova: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
New Zealand: Medsafe
Panama: Commemorative Institute GORGAS of Studies of Health
Peru: Ministry of Health
Philippines: Department of Health
Poland: Ministry of Health
Romania: Ministry of Public Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Sweden: The National Board of Health and Welfare
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Nintedanib
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014