A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01770795

Enrollment

Registered

2013-01-18

Start date

2011-01-31

Completion date

Unknown

Last updated

2013-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, gemcitabine, genexol-PM, paclitaxel

Brief summary

To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients

Interventions

DRUGGenexol-PM/Gemcitabine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	one year

Secondary

Measure	Time frame
progression free survival	one year
overall survival	one year
toxicities	one year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026