Clinical trial · Interventional
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
NCT01770795CI-TRIAL-00009010completedPhase 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)
To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genexol-PM/Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Genexol-PM/Gemcitabine
- interventionNames
- Drug: Genexol-PM/Gemcitabine
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- one year
Secondary outcomes (3)
- measure
- progression free survival
- timeFrame
- one year
- measure
- overall survival
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age over 18 * histologically or cytologically confirmted non-small cell lung cancer * stage IIIb with pleural effusion or stage IV * ECOG PS 0-2 * at least one measurable lesion * expected life span more than 3 months * normal bone marrow, liver, renal function * no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases * more than 6 months from the last adjuvant chemotherapy Exclusion Criteria: * active infection * severe comorbitidies * pregnant or lactating women * other invasive malignancies * poorly controlled symptomatic brain metastases
References
Publications (0)
Data not yet available
No reference posted for this study.