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Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806819
First Posted: December 11, 2008
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: Nintedanib (BIBF1120) Drug: Pemetrexed Drug: pemetrexed Drug: B12 Drug: dexamethasone (or corticosteroid equivalent) Drug: placebo Drug: Folic Acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

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 ]

    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 data cut-off (15 February 2013), Up to 30 months ]
    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 data cut-off (15 February 2013), Up to 30 months ]
    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 data cut-off (15 February 2013), Up to 30 months ]
    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 data cut-off (15 February 2013), Up to 30 months ]
    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 data cut-off (15 February 2013), Up to 30 months ]

    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 data cut-off (15 February 2013), Up to 30 months ]

    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 data cut-off (15 February 2013), Up to 30 months ]

    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 data cut-off (15 February 2013), Up to 30 months ]

    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 data cut-off (15 February 2013), Up to 30 months ]
    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 data cut-off (15 February 2013), Up to 30 months ]

    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.


  • Quality of Life (QoL) [ Time Frame: From randomisation until data cut-off (15 February 2013), Up to 30 months ]

    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 ]
    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 ]

    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
Study Completion Date: December 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Drug: 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.
Drug: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
Drug: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
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: Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
Placebo Comparator: Placebo plus 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: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
Drug: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
Drug: 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.
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.
Experimental: nintedanib (BIBF1120) monotherapy
nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed
Drug: 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.
Active Comparator: pemetrexed monotherapy
pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
Drug: Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
Drug: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed
Drug: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion
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.
Placebo Comparator: placebo monotherapy
placebo monotherapy only for patients who discontinue pemetrexed
Drug: 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806819


  Hide Study Locations
Locations
United States, California
Boehringer Ingelheim Investigational Site
Downy, California, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Boehringer Ingelheim Investigational Site
Fullerton, California, United States
Boehringer Ingelheim Investigational Site
Long Beach, California, United States
United States, Connecticut
Boehringer Ingelheim Investigational Site
Meriden, Connecticut, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Port St. Lucie, Florida, United States
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Stuart, Florida, United States
United States, Illinois
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Galesburg, Illinois, United States
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Skokie, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
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New Albany, Indiana, United States
United States, Kansas
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Witchita, Kansas, United States
United States, Kentucky
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Ashland, Kentucky, United States
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Louisville, Kentucky, United States
United States, Massachusetts
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Burlington, Massachusetts, United States
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Springfield, Massachusetts, United States
United States, Minnesota
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St. Louis park, Minnesota, United States
United States, Nebraska
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Grand Island, Nebraska, United States
United States, New Mexico
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Farmington, New Mexico, United States
United States, New York
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Dunkirk, New York, United States
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Goshen, New York, United States
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Lake Success, New York, United States
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Nyack, New York, United States
United States, North Carolina
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Asheville, North Carolina, United States
United States, Ohio
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Canton, Ohio, United States
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Sandusky, Ohio, United States
United States, Pennsylvania
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Ephrata, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
United States, Tennessee
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Germantown, Tennessee, United States
United States, Texas
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Amarillo, Texas, United States
United States, Washington
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Seattle, Washington, United States
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Spokane, Washington, United States
United States, Wisconsin
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Argentina
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Bs. As. Codigo Buenos Aires, Argentina
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Córdoba, Argentina
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Pergamino, Argentina
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Quilmes Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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San Miguel de Tucuman, Argentina
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San Miguel de Tucumán, Argentina
Australia, New South Wales
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Sydney, New South Wales, Australia
Australia, Queensland
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Brisbane, Queensland, Australia
Australia, South Australia
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Adelaide, South Australia, Australia
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Toorak Gardens, South Australia, Australia
Australia, Victoria
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Melbourne, Victoria, Australia
Australia, Western Australia
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Perth, Western Australia, Australia
Australia
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Sydney, Australia
Bosnia and Herzegovina
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Banja Luka, Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina
Brazil
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Belo Horizonte,Minas Gerais, Brazil
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Belo Horizonte, Brazil
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Cachoeira do Itapemirim-ES, Brazil
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Campinas SP, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Florianopolis, Brazil
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Goiania Goias, Brazil
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Ijui, Brazil
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Itajai, Brazil
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Jau/SP, Brazil
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Londrina, Parana, Brazil
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Pelotas Rio Grande do Sul, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador Bahia, Brazil
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Santo Andre, Sao Paulo, Brazil
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Santo Andre, Brazil
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Sao Paulo - SP, Brazil
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Sao Paulo, Brazil
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Sorocaba Sao Paulo, Brazil
Canada, Ontario
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
Canada
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Quebec, Canada
Chile
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Jardin del Mar, Renaca, Chile
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Las Condes, Chile
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Santiago, Chile
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Temuco, Chile
Colombia
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Monteria, Cordoba, Colombia
Ecuador
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Cuenca, Ecuador
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Quito, Ecuador
Germany
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Augsburg, Germany
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Berlin, Germany
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Gauting, Germany
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Halle (Saale), Germany
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Hemer, Germany
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München, Germany
Hong Kong
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Hong Kong, Hong Kong
Hungary
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Deszk, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
Ireland
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Dublin 8, Ireland
Korea, Republic of
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Daegu, Korea, Republic of
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Daejoen, Korea, Republic of
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Gangdong-gu, Seoul, Korea, Republic of
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Gyeonggi-do, Korea, Republic of
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Jeonbuk, Korea, Republic of
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Seochogu, Seoul, Korea, Republic of
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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
Latvia
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Daugavpils, Latvia
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Liepaja, Latvia
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Riga, Latvia
Macedonia, The Former Yugoslav Republic of
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Bitola, Macedonia, The Former Yugoslav Republic of
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Skopje, Macedonia, The Former Yugoslav Republic of
Malaysia
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Georgetown, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Penang, Malaysia
Mexico
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Chihuahua, Mexico
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Morelia, Mexico
Moldova, Republic of
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Chisinau, Moldova, Republic of
Netherlands
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Hertogenbosch, Netherlands
New Zealand
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Auckland, New Zealand
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Christchurch, New Zealand
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Palmerston North, New Zealand
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Wellington, New Zealand
Panama
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Carrasquilla Panama, Panama
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Panama, Panama
Peru
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Arequipa, Peru
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Cercado Arequipa, Peru
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Lima, Peru
Philippines
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Cebu, Philippines
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Davao City, Philippines
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Makati, Philippines
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Quezon, Philippines
Poland
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Olsztyn, Poland
Romania
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Baia Mare, Romania
Boehringer Ingelheim Investigational Site
Bucuresti, Romania
Boehringer Ingelheim Investigational Site
Cluj-Napoca, Romania
Boehringer Ingelheim Investigational Site
Iasi, Romania
Boehringer Ingelheim Investigational Site
Onesti, Romania
Boehringer Ingelheim Investigational Site
Timisoara, Romania
Serbia
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Belgrade, Serbia
Boehringer Ingelheim Investigational Site
Nis, Serbia
Boehringer Ingelheim Investigational Site
Sremska Kamenica, Serbia
Sweden
Boehringer Ingelheim Investigational Site
Gävle, Sweden
Boehringer Ingelheim Investigational Site
Stockholm, Sweden
Boehringer Ingelheim Investigational Site
Umeå, Sweden
Boehringer Ingelheim Investigational Site
Uppsala, Sweden
Taiwan
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Kaohsiung, Taiwan
Boehringer Ingelheim Investigational Site
Taichung, Taiwan
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Tainan City, Taiwan
Boehringer Ingelheim Investigational Site
Tainan, Taiwan
Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Thailand
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Bangkok, Thailand
Boehringer Ingelheim Investigational Site
Chiang Mai, Thailand
Turkey
Boehringer Ingelheim Investigational Site
Ankara, Turkey
Boehringer Ingelheim Investigational Site
Antalya, Turkey
Boehringer Ingelheim Investigational Site
Aydin, Turkey
Boehringer Ingelheim Investigational Site
Balcali-Adana, Turkey
Boehringer Ingelheim Investigational Site
Diyarbakir, Turkey
Boehringer Ingelheim Investigational Site
Gaziantep, Turkey
Boehringer Ingelheim Investigational Site
Kocaeli, Turkey
Ukraine
Boehringer Ingelheim Investigational Site
Chernigiv, Ukraine
Boehringer Ingelheim Investigational Site
Dnipropetrovks, Ukraine
Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
Boehringer Ingelheim Investigational Site
Uzhgorod, Ukraine
Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00806819     History of Changes
Other Study ID Numbers: 1199.14
2008-002072-10 ( EudraCT Number: EudraCT )
First Submitted: December 10, 2008
First Posted: December 11, 2008
Results First Submitted: November 14, 2014
Results First Posted: November 20, 2014
Last Update Posted: February 2, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Dexamethasone acetate
Dexamethasone
Nintedanib
Pemetrexed
BB 1101
Folic Acid
Vitamin B Complex
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors