CompletedPhase 3NCT00806819
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNintedanib (BIBF1120) and Pemetrexed

Plus 14 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 2, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?163 U.S. locations

Locations may change over time.

Who runs it?Boehringer Ingelheim

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Boehringer Ingelheim
Interventions being studied
Drug: Nintedanib (BIBF1120); Drug: Pemetrexed; Drug: pemetrexed; Drug: B12; Drug: dexamethasone (or corticosteroid equivalent); Drug: placebo; Drug: dexamethasone (or corticosteroid equivalent); Drug: B12; Drug: Folic Acid; Drug: B12; Drug: dexamethasone (or corticosteroid equivalent); Drug: Folic Acid; Drug: placebo; Drug: Folic Acid; Drug: Nintedanib (BIBF1120); Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Boehringer Ingelheim Investigational SiteDowny, California
  • Boehringer Ingelheim Investigational SiteFountain Valley, California
  • Boehringer Ingelheim Investigational SiteFullerton, California
  • Boehringer Ingelheim Investigational SiteLong Beach, California
  • Boehringer Ingelheim Investigational SiteMeriden, Connecticut
  • Boehringer Ingelheim Investigational SiteAventura, Florida
  • Boehringer Ingelheim Investigational SiteBoynton Beach, Florida
  • Boehringer Ingelheim Investigational SiteJacksonville, Florida
  • Boehringer Ingelheim Investigational SiteMiami, Florida
  • Boehringer Ingelheim Investigational SiteNew Port Richey, Florida
  • Boehringer Ingelheim Investigational SitePort Saint Lucie, Florida
  • Boehringer Ingelheim Investigational SiteStuart, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 2, 2017. Always confirm current availability with the study team.

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