NCT01401192

Brief Summary

This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

2.4 years

First QC Date

July 21, 2011

Last Update Submit

July 22, 2011

Conditions

Non-small Cell Lung Cancer

Keywords

thymidylate synthase

Outcome Measures

Primary Outcomes (1)

  • predictive value of TS expression

    To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value

    12 months

Secondary Outcomes (2)

  • response rate

    12 months

  • response rate

    12 months

Study Arms (4)

TS positive cohort & Gem/Cis Tx arm

EXPERIMENTAL

Among TS expression positive patients, some will be randomized to Gem/cis therapy

Drug: Gemcitabine plus cisplatin

TS+ cohort & Pem/Cis arm

ACTIVE COMPARATOR

Among patients with TS+, randomised to Pem/cis chemotherapy

Drug: pemetrexed plus cisplatin

TS negative cohort & Pem/Cis Tx arm

ACTIVE COMPARATOR

Among patients with TS-, some will be randomised to Pem/cis Tx arm

Drug: pemetrexed plus cisplatin

TS negative cohort & Gem/Cis Tx arm

EXPERIMENTAL

Among patients with TS-, some will be randomised to Gem/Cis Tx arm

Drug: Gemcitabine plus cisplatin

Interventions

Gemcitabine plus cisplatinDRUG

Gemcitabine 1000mg/m2 D1, D8 \& cisplatin 70mg/m2 D1 every 3 weeks

TS positive cohort & Gem/Cis Tx arm
pemetrexed plus cisplatinDRUG

Pemetrexed 500mg/m2 \& cisplatin 70mg/m2 D1 every 3 weeks

TS+ cohort & Pem/Cis arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed nonsquamous NSCLC
  • Stage IIIb, IV or recurrent NSCLC
  • Age ≥ 18years
  • ECOG performance status of 0 to 1
  • Known TS immunohistochemical analysis data
  • At least one measurable lesion by RECIST 1.1
  • No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
  • Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
  • At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
  • Adequate renal function: estimated creatinine clearance ≥ 50mL/min

You may not qualify if:

  • Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
  • Patients with post-obstructive pneumonia or uncontrolled serious infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.

    PMID: 26124486DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GemcitabineCisplatinPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Myung-Ju Ahn, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myung-Ju Ahn, Pf

CONTACT

822-3410-3459silkahn@skku.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 25, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2013

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

KR(1)