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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00806819




Registration number
NCT00806819
Ethics application status
Date submitted
10/12/2008
Date registered
11/12/2008
Date last updated
2/02/2017

Titles & IDs
Public title
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
Scientific title
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
Secondary ID [1] 0 0
2008-002072-10
Secondary ID [2] 0 0
1199.14
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nintedanib (BIBF1120)
Treatment: Drugs - Pemetrexed
Treatment: Drugs - pemetrexed
Treatment: Drugs - B12
Treatment: Drugs - dexamethasone (or corticosteroid equivalent)
Treatment: Drugs - placebo
Treatment: Drugs - dexamethasone (or corticosteroid equivalent)
Treatment: Drugs - B12
Treatment: Drugs - Folic Acid
Treatment: Drugs - B12
Treatment: Drugs - dexamethasone (or corticosteroid equivalent)
Treatment: Drugs - Folic Acid
Treatment: Drugs - placebo
Treatment: Drugs - Folic Acid
Treatment: Drugs - Nintedanib (BIBF1120)
Treatment: Drugs - Pemetrexed

Experimental: nintedanib (BIBF1120) plus pemetrexed - nintedanib (BIBF1120) along with standard therapy of pemetrexed

Placebo comparator: Placebo plus pemetrexed - Pemetrexed standard therapy

Experimental: nintedanib (BIBF1120) monotherapy - nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed

Active comparator: pemetrexed monotherapy - pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo

Placebo comparator: placebo monotherapy - placebo monotherapy only for patients who discontinue pemetrexed


Treatment: Drugs: Nintedanib (BIBF1120)
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.

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

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

Treatment: Drugs: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Treatment: Drugs: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Treatment: Drugs: placebo
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.

Treatment: Drugs: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Treatment: Drugs: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Treatment: Drugs: 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.

Treatment: Drugs: B12
1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Treatment: Drugs: dexamethasone (or corticosteroid equivalent)
4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Treatment: Drugs: 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.

Treatment: Drugs: placebo
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.

Treatment: Drugs: 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.

Treatment: Drugs: Nintedanib (BIBF1120)
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.

Treatment: Drugs: Pemetrexed
500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by Central Independent Review
Timepoint [1] 0 0
From randomisation until cut-off date 9 July 2012
Secondary outcome [1] 0 0
Overall Survival (Key Secondary Endpoint)
Timepoint [1] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [2] 0 0
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
Timepoint [2] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [3] 0 0
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator
Timepoint [3] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [4] 0 0
Objective Tumor Response
Timepoint [4] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [5] 0 0
Duration of Confirmed Objective Tumour Response
Timepoint [5] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [6] 0 0
Time to Confirmed Objective Tumour Response
Timepoint [6] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [7] 0 0
Disease Control
Timepoint [7] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [8] 0 0
Duration of Disease Control
Timepoint [8] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [9] 0 0
Change From Baseline in Tumour Size
Timepoint [9] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [10] 0 0
Clinical Improvement.
Timepoint [10] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [11] 0 0
Quality of Life (QoL)
Timepoint [11] 0 0
From randomisation until data cut-off (15 February 2013), Up to 30 months
Secondary outcome [12] 0 0
Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide
Timepoint [12] 0 0
Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3
Secondary outcome [13] 0 0
Incidence and Intensity of Adverse Events
Timepoint [13] 0 0
From the first drug administration until 28 days after the last drug administration, up to 36 months

Eligibility
Key inclusion 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 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
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 exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
718
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Sydney
Recruitment hospital [2] 0 0
Boehringer Ingelheim Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [5] 0 0
Boehringer Ingelheim Investigational Site - Melbourne
Recruitment hospital [6] 0 0
Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Toorak Gardens
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Connecticut
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Florida
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Illinois
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Indiana
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Umeå
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Kaohsiung
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Tainan City
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Tainan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Ankara
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Turkey
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Antalya
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Aydin
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Balcali-Adana
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Diyarbakir
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Gaziantep
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Turkey
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Kocaeli
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Ukraine
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Chernigiv
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Ukraine
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Dnipropetrovks
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Ukraine
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Kharkiv
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Uzhgorod
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Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00806819
Trial related presentations / publications
Lesaffre E, Edelman MJ, Hanna NH, Park K, Thatcher N, Willemsen S, Gaschler-Markefski B, Kaiser R, Manegold C. Statistical controversies in clinical research: futility analyses in oncology-lessons on potential pitfalls from a randomized controlled trial. Ann Oncol. 2017 Jul 1;28(7):1419-1426. doi: 10.1093/annonc/mdx042.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00806819