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NCT00806819 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
718
Enrollment target
20
Study locations

NCT00806819: Completed Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Boehringer Ingelheim.

NCT00806819 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that has completed, run by Boehringer Ingelheim. The registered enrollment target is 718 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00806819, a Phase 3 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
718 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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.

Conditions Studied

Carcinoma, Non-Small Cell Lung

Interventions

  • DRUG Pemetrexed
  • DRUG pemetrexed
  • DRUG Nintedanib (BIBF1120)
  • DRUG B12
  • DRUG dexamethasone (or corticosteroid equivalent)

Study Locations (20)

Florida

  • Boehringer Ingelheim Investigational Site - Aventura
  • Boehringer Ingelheim Investigational Site - Boynton Beach
  • Boehringer Ingelheim Investigational Site - Jacksonville
  • Boehringer Ingelheim Investigational Site - Miami
  • Boehringer Ingelheim Investigational Site - New Port Richey
  • Boehringer Ingelheim Investigational Site - Port Saint Lucie
  • Boehringer Ingelheim Investigational Site - Stuart

California

  • Boehringer Ingelheim Investigational Site - Downy
  • Boehringer Ingelheim Investigational Site - Fountain Valley
  • Boehringer Ingelheim Investigational Site - Fullerton
  • Boehringer Ingelheim Investigational Site - Long Beach

Illinois

  • Boehringer Ingelheim Investigational Site - Galesburg
  • Boehringer Ingelheim Investigational Site - Skokie

Indiana

  • Boehringer Ingelheim Investigational Site - Indianapolis
  • Boehringer Ingelheim Investigational Site - New Albany

Kentucky

  • Boehringer Ingelheim Investigational Site - Ashland
  • Boehringer Ingelheim Investigational Site - Louisville

Connecticut

  • Boehringer Ingelheim Investigational Site - Meriden

Kansas

  • Boehringer Ingelheim Investigational Site - Witchita

Massachusetts

  • Boehringer Ingelheim Investigational Site - Burlington

Trial Details

FieldValue
Enrollment Target 718 participants
Start Date 2008-12
Est. Completion 2015-12
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT00806819 record still lists

NCT00806819 is an interventional study that assigns participants to a tested intervention. The registered 718 participants enrollment target is mid-sized for trials with a published cap, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (126% higher).

The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Pemetrexed is the first listed.

NCT00806819 names 20 study sites across 8 states, led by Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00806819 about?

NCT00806819 is a clinical study titled "Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC". 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.

What is the current status of trial NCT00806819?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 718 participants. The study started on 2008-12. Estimated completion is 2015-12.

What conditions does trial NCT00806819 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT00806819?

The interventions under investigation include: Pemetrexed (DRUG), pemetrexed (DRUG), Nintedanib (BIBF1120) (DRUG), B12 (DRUG), dexamethasone (or corticosteroid equivalent) (DRUG).

Who is sponsoring clinical trial NCT00806819?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00806819 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00806819's enrollment target sits among peer trials

718 15th of 130 higher than 116 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00806819, the US trial registry maintained by the National Library of Medicine. NCT00806819 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.