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.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Placebo; Drug: BIBF 1120

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346540

1199.82

2010-019707-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

BIBF 1120

Experimental group

Description:

VEGF inhibitor

Treatment:

Drug: BIBF 1120

Placebo

Placebo Comparator group

Description:

BIBF 1120 placebo

Treatment:

Drug: Placebo