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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346540
First Posted: May 3, 2011
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose

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
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 ]

Enrollment: 16
Actual Study Start Date: April 14, 2011
Study Completion Date: January 17, 2017
Primary Completion Date: April 25, 2013 (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

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346540


Locations
Italy
1199.82.39004 Boehringer Ingelheim Investigational Site
Milano, Italy
Netherlands
1199.82.3102 Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Spain
1199.82.3401 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1199.82.3406 Boehringer Ingelheim Investigational Site
Madrid, Spain
1199.82.3410 Boehringer Ingelheim Investigational Site
Málaga, Spain
United Kingdom
1199.82.4401 Boehringer Ingelheim Investigational Site
London, United Kingdom
1199.82.4402 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01346540     History of Changes
Other Study ID Numbers: 1199.82
2010-019707-32 ( EudraCT Number: EudraCT )
First Submitted: April 19, 2011
First Posted: May 3, 2011
Last Update Posted: July 2, 2017
Last Verified: June 2017

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