NCT00806819|CompletedPhase 3Results

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

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1199.142008-002072-10

Study Type

interventional

Target

718

Locations

31 countries

Sites

159

Timeline

RegisteredDec 2008

StartedDec 2008

CompletionDec 2015

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

718

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2008

Longer than P75 for phase_3

Geographic Reach

31 countries

159 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 years study duration

Study Start

First participant enrolled

December 1, 2008

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

November 20, 2014

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

Last Updated

February 2, 2017

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

December 10, 2008

Results QC Date

November 14, 2014

Last Update Submit

December 8, 2016

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS) as Assessed by Central Independent Review
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.
From randomisation until cut-off date 9 July 2012

Secondary Outcomes (13)

Overall Survival (Key Secondary Endpoint)
From randomisation until data cut-off (15 February 2013), Up to 30 months
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
From randomisation until data cut-off (15 February 2013), Up to 30 months
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator
From randomisation until data cut-off (15 February 2013), Up to 30 months
Objective Tumor Response
From randomisation until data cut-off (15 February 2013), Up to 30 months
Duration of Confirmed Objective Tumour Response
From randomisation until data cut-off (15 February 2013), Up to 30 months
+8 more secondary outcomes

Study Arms (5)

nintedanib (BIBF1120) plus pemetrexed

EXPERIMENTAL

nintedanib (BIBF1120) along with standard therapy of pemetrexed

Drug: Nintedanib (BIBF1120)Drug: B12Drug: dexamethasone (or corticosteroid equivalent)Drug: Folic AcidDrug: Pemetrexed

Placebo plus pemetrexed

PLACEBO COMPARATOR

Pemetrexed standard therapy

Drug: pemetrexedDrug: dexamethasone (or corticosteroid equivalent)Drug: B12Drug: placeboDrug: Folic Acid

nintedanib (BIBF1120) monotherapy

EXPERIMENTAL

nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed

Drug: Nintedanib (BIBF1120)

pemetrexed monotherapy

ACTIVE COMPARATOR

pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo

Drug: PemetrexedDrug: B12Drug: dexamethasone (or corticosteroid equivalent)Drug: Folic Acid

placebo monotherapy

PLACEBO COMPARATOR

placebo monotherapy only for patients who discontinue pemetrexed

Drug: placebo

Interventions

Nintedanib (BIBF1120)DRUG

starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.

nintedanib (BIBF1120) plus pemetrexed

PemetrexedDRUG

500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

pemetrexed monotherapy

B12DRUG

1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

pemetrexed monotherapy

dexamethasone (or corticosteroid equivalent)DRUG

4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

pemetrexed monotherapy

placeboDRUG

starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid.

placebo monotherapy

Folic AcidDRUG

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.

pemetrexed monotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patient aged 18 years or older.
Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or recurrent non small cell lung cancer (NSCLC) (non squamous histologies)
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).
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.
Life expectancy of at least three months.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Patient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.

You may not qualify if:

Previous therapy with other vascular endothelial growth factor (VEGF) inhibitors (other than bevacizumab) or pemetrexed for treatment of NSCLC
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
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
Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
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)
Radiographic evidence of cavitary or necrotic tumors
Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
History of clinically significant haemoptysis within the past 3 months
Therapeutic anticoagulation
History of major thrombotic or clinically relevant major bleeding event in the past 6 months
Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months,
Inadequate kidney, liver, blood clotting function
Inadequate blood count
Significant weight loss (\> 10 %) within the past 6 weeks prior to treatment in the present trial
Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma
+3 more criteria

Contact the study team to confirm eligibility.