Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Adenocarcinoma
Intervention: Nintedanib; Docetaxel
Intervention description: Nintedanib; Docetaxel
Intervention MeSH terms: Docetaxel; Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75
      mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area
      (BSA) <1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung
      cancer (NSCLC) after failure of first line platinum- based chemotherapy
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients aged 20 years or older at the date of informed consent

          2. Patients with body surface area (BSA)<1.5 m2 at screening

          3. Patients with histologically/cytologically confirmed locally advanced or metastatic
             adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line
             platinum-based chemotherapy (patients with non-target lesion only are eligible) First
             line chemotherapy may include continuation or switch maintenance therapy. One prior
             adjuvant and/or neoadjuvant chemotherapy is accepted.

          4. Patients who have life expectancy of at least 3 months

          5. Patients who are Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
             0 or 1 at screening

          6. Patients obtained written informed consent in accordance with International Conference
             on Harmonisation-Good Clinical Practice (ICH-GCP)and Japanese GCP

        Exclusion criteria:

          1. Patients who have received more than one prior line of chemotherapy (i.e., second or
             third line chemotherapy) for advanced or metastatic NSCLC (Prior monotherapies with an
             epidermal growth factor receptor tyrosine kinase inhibitors [EGFR-TKI]) or anaplastic
             lymphoma kinase (ALK) inhibitor can be allowed)

          2. Patients who have received previous therapy with other vascular endothelial growth
             factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors (other
             than bevacizumab) for the treatment of NSCLC at any time

          3. Patients who have received following treatments within 4 weeks prior to start of study
             therapy 1) Other investigational drugs 2) Chemo-, hormone-, immunotherapy, or
             monoclonal antibody.

          4. Patients who have received molecular target therapy including EGFR TKIs and ALK
             inhibitors within 2 weeks prior to start of study therapy

          5. Patents who have received radiotherapy within the past 3 months (in the case of
             limited -field [e.g. brain or bone metastasis] radiotherapy with palliative intent),
             within 2 weeks) prior to start of study therapy

          6. Patients who not recovered clinically relevant therapy related toxicities from
             previous chemotherapy and/or radiotherapy (=CTCAE grade 2 Adverse Event from previous
             treatment) at screening

        further exclusion criteria may be applied