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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.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01346540
First received: April 19, 2011
Last updated: November 5, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Phase II: Progression Free Survival. [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase II: Realtionship of tumour size to clinical response. [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
  • Phase I: Evaluation of objective response. [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
  • Phase II: Overall Survival [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
  • Phase I: Evalualuation of best overall tumour response. [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01346540     History of Changes
Other Study ID Numbers: 1199.82, 2010-019707-32
Study First Received: April 19, 2011
Last Updated: November 5, 2014
Health Authority: Italy: National Institute of Health
Netherlands: Central Committee Research Involving Human Subjects
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on November 25, 2014