Clinical trial · Interventional
Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer
A Phase II Trial of Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer After Failure of Platinum Doublet (Except Pemetrexed) Therapy
NCT01969955CI-TRIAL-00014349unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Lung | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nanoparticle albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nanoparticle albumin-bound paclitaxel
- description
- Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
- interventionNames
- Drug: nanoparticle albumin-bound paclitaxel
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- up to one year
- description
- Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Secondary outcomes (4)
- measure
- progression-free survival
- timeFrame
- up to 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed-consent form; 2. Age no less than 18 years; 3. Histologically confirmed locally advanced or metastatic squamous lung cancer; 4. Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks; 5. RECIST measurable lesions; 6. Disease progression after failure of platinum-based doublet therapy; 7. Adequate liver/renal/bone marrow function; 8. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end; 9. Compliance, and can be followed up regularly. Exclusion Criteria: 1. Pregnant or breast-feeding female, or not willing to take contraception measures during study; 2. Radiotherapy within 30 days, systematic therapy within 21 days; 3. Serious infection requiring antibiotics intervention during recruitment; 4. Allergic to study drug; 5. Require concurrent biological target therapy; 6. More than grade 1 neuropathy; 7. Uncontrolled brain metastasis or mental illness; 8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc; 9. Other malignancy within 5 years; 10. Can't be followed up or obey protocol; 11. Ineligible by the judge of the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.