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Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: December 10, 2008   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00806819
  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: BIBF 1120
Drug: placebo
Drug: pemetrexed
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Pemetrexed Pemetrexed disodium BIBF 1120
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Double-Blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer Patients After Failure of First Line Therapy

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • progression free survival [ Time Frame: October 2010 ]

Secondary Outcome Measures:
  • overall survival tumor response according to modified RECIST criteria incidence and intensity of adverse events clinical improvement changes in safety laboratory parameters quality of life measurement pharmacokinetics of BIBF 1120 [ Time Frame: November 2012 ]

Estimated Enrollment: 1302
Study Start Date: December 2008
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  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 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806819

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 207 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1199.14, Eudra CT :2008-002072-10
Study First Received: December 10, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00806819     History of Changes
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 Publica de Chile;   Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Ecuador: Public Health Ministry;   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;   Serbia and Montenegro: Agency for Drugs and Medicinal Devices;   Taiwan: Department of Health;   Thailand: Food and Drug Administration;   Turkey: Ministry of Health;   United States: Food and Drug Administration;   Venezuela: Rafael Rangel National Institute of Health

Study placed in the following topic categories:
Thoracic Neoplasms
Antimetabolites
Folic Acid Antagonists
Recurrence
Carcinoma
Pemetrexed
Folic Acid
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on May 06, 2009