Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS Positive Patients With Non-small Cell Lung Cancer | — | UNRESOLVED | — |
| Squamous Cell Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
- interventionNames
- Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- 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 outcomes (7)
- measure
- Progression-free survival
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available