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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.

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: April 19, 2011
Last updated: October 31, 2016
Last verified: October 2016

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

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: BIBF 1120
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: April 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120
VEGF inhibitor
Drug: BIBF 1120
VEGF inhibitor
Placebo Comparator: Placebo
BIBF 1120 placebo
Drug: Placebo
BIBF 1120 placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01346540

Boehringer Ingelheim Investigational Site
Milano, Italy
Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Boehringer Ingelheim Investigational Site
Barcelona, Spain
Boehringer Ingelheim Investigational Site
Madrid, Spain
Boehringer Ingelheim Investigational Site
Málaga, Spain
United Kingdom
Boehringer Ingelheim Investigational Site
London, United Kingdom
Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01346540     History of Changes
Other Study ID Numbers: 1199.82
2010-019707-32 ( EudraCT Number: EudraCT )
Study First Received: April 19, 2011
Last Updated: October 31, 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 25, 2017