Clinical trial NCT01346540: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
timeFrame: Up to 21 days from first drug administration
measure: Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1.
timeFrame: Up to 21 days from first drug administration
Secondary outcomes:
measure: Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00
timeFrame: From the first drug administration until 28 days after last study drug administration, up to 804 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: 1199.82.39004 Boehringer Ingelheim Investigational Site
city: Maastricht
country: Netherlands
facility: 1199.82.3102 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1199.82.3401 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1199.82.3406 Boehringer Ingelheim Investigational Site
city: Málaga
country: Spain
facility: 1199.82.3410 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1199.82.4401 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1199.82.4402 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: