Lume Lung 2 : BIBF 1120 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: August 6, 2014
Last verified: August 2014
  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: Pemetrexed
Drug: Placebo plus pemetrexed
Drug: Folic Acid
Drug: BIBF1120
Drug: BIBF1120 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 BIBF 1120 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • tumor response according to modified RECIST criteria [ Time Frame: 6 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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • clinical improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • changes in safety laboratory parameters from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • quality of life measurement (EQ-5D, EORTC, QLQ C-30, EORTC QLQ LC 13) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • pharmacokinetics of BIBF 1120 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 826
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 plus pemetrexed
BIBF 1120 along with standard therapy of pemetrexed
Drug: Folic Acid Drug: BIBF1120 Drug: BIBF1120 plus pemetrexed
Active 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: Placebo plus 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 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
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

  Show 203 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More 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
Last Updated: August 6, 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:
Nintedanib
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Folic Acid
Vitamin B Complex
Pemetrexed
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014