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A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.

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ClinicalTrials.gov Identifier: NCT01346540
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

April 19, 2011
May 3, 2011
July 2, 2017
April 14, 2011
April 25, 2013   (Final data collection date for primary outcome measure)
  • Phase I: Determination of Maximum Tolerated Dose (MTD) of BIBF 1120 added to cisplatin/gemcitabine based on the occurrence of DLTs during treatment cycle 1. [ Time Frame: up to 21 days ]
  • Phase II: Progression Free Survival. [ Time Frame: up to 55 months ]
  • Phase I: Frequency, intensity and duration of adverse events, graded according to CTCAE [ Time Frame: 9 months ]
  • PhaseII: Progression Free Survival. [ Time Frame: 24 months ]
Complete list of historical versions of study NCT01346540 on ClinicalTrials.gov Archive Site
  • Phase II: Realtionship of tumour size to clinical response. [ Time Frame: up to 55 months ]
  • Phase I: Evaluation of objective response. [ Time Frame: up to 55 months ]
  • Phase II: Overall Survival [ Time Frame: up to 55 months ]
  • Phase I: Evalualuation of best overall tumour response. [ Time Frame: up to 55 months ]
  • Phase I: Incidence of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 [ Time Frame: up to 55 months ]
  • Phase I: Evaluation of objective response and best overall tumour response. [ Time Frame: 24 months ]
  • Phase I:Pharmacokinetic parameters, including area under the plasma concentration-time curve (AUC), maximum measured plasma concentration (Cmax), time from dosing to maximum plasma concentration (tmax), terminal half-life of the analyte in plasma (t1/2) [ Time Frame: 24 months ]
  • Phase II: Objective Response [ Time Frame: 24 months ]
  • Phase II: Disease Control [ Time Frame: 24 months ]
  • Phase II: Overall Survival [ Time Frame: 24 months ]
  • Phase II: Duration of Objective Response. [ Time Frame: 24 months ]
  • Phase II: Analysis of Health -Related Quality of Life Questionnaires [ Time Frame: 24 months ]
  • Phase II: Duration of Disease Control. [ Time Frame: 24 months ]
Not Provided
Not Provided
 
A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.
LUME-Lung 3: A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology

The LUME-Lung3 study is in 2 parts:

Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin.

Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: BIBF 1120
    VEGF inhibitor
  • Drug: Placebo
    BIBF 1120 placebo
  • Experimental: BIBF 1120
    VEGF inhibitor
    Intervention: Drug: BIBF 1120
  • Placebo Comparator: Placebo
    BIBF 1120 placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
165
January 17, 2017
April 25, 2013   (Final data collection date for primary outcome measure)

Inclusion criteria:

Run-in Phase I

  1. Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent Non Small Cell Lung Cancer (NSCLC) with squamous cell histology.
  2. Measurable disease according to Response Evaluation Criteria in Solid Tumours ( RECIST 1.1).
  3. Patient Eastern Cooperative Oncology Group (ECOG) score of 0-1.
  4. Male or female patients age = 18 years.
  5. Life expectancy of at least three (3) months.
  6. Written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.

    Phase II - in addition to the above criteria:

  7. Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.

Exclusion criteria:

  1. Prior therapy for advanced or metastatic or recurrent Non Small Cell Lung Cancer (NSCLC). One prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
  2. Prior treatment with other Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors (other than bevacizumab)
  3. Any contraindications for treatment with gemcitabine and/or cisplatin.
  4. Use of any investigational drug within 4 weeks of entering the 1199.82 study.
  5. History of major thrombotic or clinically relevant bleeding event in the past 6 months.
  6. Significant cardiovascular diseases (i.e. hypertension not controlled by medication.
  7. Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
  8. Active brain metastases
  9. Radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
  10. Any other current malignancy or malignancy diagnosed within the past five (5) years.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Netherlands,   Spain,   United Kingdom
France,   Germany,   Portugal
 
NCT01346540
1199.82
2010-019707-32 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP