Loading clinical trials...

Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00806819•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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
+8 more criteria

Locations (163)

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

Boehringer Ingelheim Investigational Site

Meriden, Connecticut, United States

Boehringer Ingelheim Investigational Site

Aventura, Florida, United States

Boehringer Ingelheim Investigational Site

Boynton Beach, Florida, United States

Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Key Dates

Start Date

December 1, 2008

Primary Completion Date

June 1, 2011

Completion Date

December 1, 2015

Last Updated

February 2, 2017

Enrollment

718

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

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

DRUG

Sponsors

Lead Sponsor

Boehringer Ingelheim

Related Studies

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions