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CompletedNCT01023347Updated May 9, 2017

A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer

A Phase 2 interventional study of Paclitaxel (Genexol®) and Paclitaxel loaded polymeric micelle (Genexol-PM®) in Non Small Cell Lung Cancer, sponsored by Samyang Biopharmaceuticals Corporation. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Samyang Biopharmaceuticals Corporation · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jun 2008, registered Nov 2009).
Phase
Phase 2
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • NSCLC
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 276 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Samyang Biopharmaceuticals Corporation is the lead sponsor of 30 studies on the registry; 6 are open to participants now.

Browse Samyang Biopharmaceuticals Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv)
  • At least one measurable lesion(s) by RECIST criteria
  • No previous palliative chemotherapy
  • Age 18 or higher.
  • ECOG PS 0-2
  • Life expectancy of at least 3 months.
  • Adequate hematologic, hepatic, renal function
  • Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul)
  • Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit)
  • Adequate renal function (≤ serum creatinine 1.5 mg/dl)
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • No prior chemotherapy for NSCLC
  • Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
  • Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)
  • Clinically significant cardiac disease (medically uncontrollable heart disease)
  • Active infection or other serious medical illness
  • Contraindication to any drug contained in the chemotherapy regimen
  • Pregnant or lactating women were excluded.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
276 participants (actual)

Study arms

  • Active comparator
    Paclitaxel (Genexol®) and Cisplatin

    Drug: Paclitaxel (Genexol®)

  • Experimental
    Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin

    Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)

06

What researchers measure

Primary outcomes

  1. response rate

    overall responses are complete response and partial response

    Time frame: up to 6 cycles

Secondary outcomes

  1. overall survival

    OS was calculated by the time from randomization date to the date of death

    Time frame: up to 3 years

  2. progression-free survival

    PFS was calculated by the time from randomization date to objective tumor progression or death.

    Time frame: up to 3 years

  3. toxicity profiles

    Incidence of AE, laboratory test results (hematology, blood chemistry, and urine test), physical examination, vital sign, and ECOG performance were used for safety endpoints

    Time frame: up to 6 cycles

07

Study locations

1 site
  • Chungnam National University Hospital
    Daejeon, Jung-gu 301-721, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2008 to primary completion in Dec 2009, 18 months.

Of 292 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's 18 months is below that.

Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2009
First posted
Dec 2, 2009
StartActual
Jun 2008
Primary completionActual
Dec 2009
CompletionActual
Jun 2012
Last update
May 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01023347
Lead sponsor
Samyang Biopharmaceuticals Corporation
Responsible party
Sponsor
First posted
Dec 2, 2009
Start date
Jun 2008
Primary completion
Dec 2009
Completion
Jun 2012
Last update
May 9, 2017

Study contacts

Sun Young Kim, Ph.D.
principal investigator · Chungnam National University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Genexol-PM

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