A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.

Official Title
-----------------
An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer

Conditions
-----------------
KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females at least 18 years of age Diagnosis of NSCLC with locally advanced or metastatic disease Positive for KRAS mutation or Squamous cell histology Previously treated with one platinum-based chemotherapy Disease status must be that of measurable and/or evaluable disease Performance status of 0 to 1 on the ECOG Scale Prior chemotherapy completed at least 3 weeks prior to study enrollment Prior radiation therapy allowed to < 25% of the bone marrow Patient compliance and geographic proximity that allow adequate follow-up Adequate organ function Patients with reproductive potential must use contraceptive methods Signed informed consent from patient Exclusion Criteria: Active infection Pregnancy or planning to become pregnant Breast feeding Serious concomitant systemic disorders Second primary malignancy Patients who are symptomatic from brain metastasis Presence of detectable (by physical exam) third-space fluid collections More than 1 prior cytotoxic chemotherapy regimen for advanced disease Prior treatment with docetaxel History of severe hypersensitivity reaction to polysorbate 80 Peripheral neuropathy at study entry Patients known to be HIV positive Patients known to be seropositive for hepatitis C hepatitis B Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)<br> | Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate |  | Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks. | 
| Overall survival |  | Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation | 
| Duration of response |  | Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks | 
| Time to response |  | change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug | 
| Disease control rate |  | Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks | 
| Safety and tolerability, as measured by number of participants with adverse events. |  | Measured from first dose of study drug until 30 days after study discontinuation. | 
| Objective response rate |  | change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks, |