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.
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: BIBF 1120; Placebo
Intervention description: VEGF inhibitor; BIBF 1120 placebo
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.