NCT01193959

Brief Summary

Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

August 26, 2010

Last Update Submit

September 8, 2022

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.

    one year

Secondary Outcomes (1)

  • Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy.

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-small cell lung cancer patients treated with single agent pemetrexed

You may qualify if:

  • Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution
  • Patients treated with single agent pemetrexed for metastatic disease
  • Availability of full clinical data

You may not qualify if:

  • Cytological diagnosis of advanced Non-small cell lung cancer
  • Lack of tumor tissue at our institution
  • Lack of full clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Armando SANTORO, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2010

First Posted

September 2, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

September 10, 2022

Record last verified: 2022-09

Locations

IT(1)