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

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT00685750

Acronym / sponsor ID

109752

Conditions

Lung Cancer, Non-Small Cell

Keywords

tumor antigen, biomarkers

Study type

Interventional

Recruitment status

TerminatedReason 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

Enrolment

88 participants (actual)

Lead sponsor

GlaxoSmithKlineIndustry (pharma, biotech, devices)

Study start

28 Apr 2008 (actual)

Primary completion

17 Dec 2013 (actual)

Study completion

17 Dec 2013 (actual)

First posted

28 May 2008 (estimated)

Results

Posted 20 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Screening

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

7

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Subjects With Expression of Tumor Antigens

   Time frame: Before and after administration of standard of care treatment course, up to 3 months

   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

2. Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic

   Time frame: Before and after administration of standard of care treatment course, up to 3 months

   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.

3. The Serum Proteome

   Time frame: After administration of standard of care treatment course

4. Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.

   Time frame: After administration of standard of care treatment course

5. 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.

   Time frame: After administration of standard of care treatment course

6. Number of Patients Responding to Treatment, by Best Clinical Response Type

   Time frame: At 6 months after the initiation of the ipilimumab therapy

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

34 sites in 5 countries: see every site and its status.