This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments nintedanib, docetaxel
Phase phase 1
Sponsor Boehringer Ingelheim
Start date December 2014
End date January 2016
Trial size 10 participants
Trial identifier NCT02300298, 1199.90


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
patients to receive backbone chemotherapy and nintedanib

Primary Outcomes

Number of patients experiencing dose limiting toxicity (DLT) in Cycle 1
time frame: 6 weeks

Secondary Outcomes

Cmax (maximum measured concentration of the analyte in plasma)
time frame: 6 weeks
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable plasma concentration)
time frame: 6 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: 6 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion criteria: 1. Patients aged 20 years or older at the date of informed consent 2. Patients with BSA<1.5 m2 at screening 3. Patients with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype 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 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 AE from previous treatment) at screening further exclusion criteria may be applied

Additional Information

Official title An Open Label Phase I Safety run-in Trial of Oral Nintedanib Plus Docetaxel Therapy in Japanese Patients With Locally Advanced or Metastatic Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of Platinum-based First Line Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.