This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments bibf 1120, placebo
Phase phase 1
Sponsor Boehringer Ingelheim
Start date April 2011
End date April 2018
Trial size 16 participants
Trial identifier NCT01346540, 1199.82, 2010-019707-32


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
VEGF inhibitor
bibf 1120
VEGF inhibitor
(Placebo Comparator)
BIBF 1120 placebo
BIBF 1120 placebo

Primary Outcomes

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 Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.