NCT00685750|TerminatedResults

Study Stopped

Slow enrolment over the last 2 years with none in the past 1 year. No increase in the number of completed subjects for 1 year and no more ongoing study subjects

Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma

Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

109752

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredMay 2008

StartedApr 2008

CompletionDec 2013

Brief Summary

This study intends to analyze the expression of specific sets of markers in tumor samples and in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma. The data obtained in this study will be used to guide future development of immunotherapies for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of markers potentially predictive of clinical response to specific anticancer therapies.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach

5 countries

34 active sites

Status

terminated

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

5.6 years study duration

Study Start

First participant enrolled

April 28, 2008

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2013

Completed

5.5 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed

Last Updated

June 20, 2019

Status Verified

March 1, 2019

Enrollment Period

5.6 years

First QC Date

May 23, 2008

Results QC Date

September 29, 2017

Last Update Submit

March 22, 2019

Conditions

Lung Cancer, Non-Small Cell

Keywords

tumor antigenbiomarkers

Outcome Measures

Primary Outcomes (6)

Number of Subjects With Expression of Tumor Antigens
The outcome presents the number of participants with expression of MAGE-A3 and NY-ESO-1 tumor antigens, after administration of standard of care treatment course compared to before administration
Before and after administration of standard of care treatment course, up to 3 months
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic
The outcome presents the number of participants with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic from before and after standard cancer treatment, for comparison.
Before and after administration of standard of care treatment course, up to 3 months
The Serum Proteome
After administration of standard of care treatment course
Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.
After administration of standard of care treatment course
Number of NSCLC Patients With Gene-expression Signature and Tumor Antigens in Distinct Concomitant Tumor Lesions Obtained at the Same Time From the Same Patient.
After administration of standard of care treatment course
Number of Patients Responding to Treatment, by Best Clinical Response Type
This outcome was assessed for metastatic melanoma patients treated with ipilimumab, in order to explore the predictive value to clinical activity of pre-identified immune-related gene-expression signature, by evaluating the patient's best clinical response to this treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
At 6 months after the initiation of the ipilimumab therapy

Study Arms (7)

ME1

OTHER

Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment