NCT00685750

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

Terminated NA Results posted Last updated 20 June 2019

What this trial tests

NA trial testing Collection of tumor and blood samples in Lung Cancer, Non-Small Cell in 88 participants. Terminated before completion.

Timeline

28 April 2008

Primary endpoint
17 December 2013

17 December 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	88
Start date	28 April 2008
Primary completion	17 December 2013
Estimated completion	17 December 2013
Sites	34 locations across France, Italy, Sweden, Germany, United States

Drugs / interventions tested

• Collection of tumor and blood samples

Conditions studied

• Lung Cancer, Non-Small Cell — all drugs for Lung Cancer, Non-Small Cell →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Lung Cancer, Non-Small Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Expression of Tumor Antigens Primary · 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

MAGE-A3

Group	Value	95% CI
Melanoma 1 Group	8
Melanoma 2 Group	0
Melanoma 3 Group	11
Melanoma 4 Group	1
Melanoma 5 Group	5
Melanoma 6 Group	6
Non-Small Cell Group	1
Melanoma 1 Group	7
Melanoma 2 Group	0
Melanoma 3 Group	0
Melanoma 4 Group	0
Melanoma 5 Group	5
Melanoma 6 Group	6
Non-Small Cell Group	5
Melanoma 1 Group	0
Melanoma 2 Group	0
Melanoma 3 Group	0
Melanoma 4 Group	0
Melanoma 5 Group	1
Melanoma 6 Group	1
Non-Small Cell Group	0
Melanoma 1 Group	0
Melanoma 2 Group	2
Melanoma 3 Group	9
Melanoma 4 Group	0
Melanoma 5 Group	2
Melanoma 6 Group	3
Non-Small Cell Group	2

NY-ESO-01

Group	Value	95% CI
Melanoma 1 Group	4
Melanoma 2 Group	1
Melanoma 3 Group	2
Melanoma 4 Group	1
Melanoma 5 Group	4
Melanoma 6 Group	4
Non-Small Cell Group	NA
Melanoma 1 Group	9
Melanoma 2 Group	1
Melanoma 3 Group	14
Melanoma 4 Group	0
Melanoma 5 Group	6
Melanoma 6 Group	11
Non-Small Cell Group	NA
Melanoma 1 Group	1
Melanoma 2 Group	0
Melanoma 3 Group	1
Melanoma 4 Group	0
Melanoma 5 Group	1
Melanoma 6 Group	1
Non-Small Cell Group	NA
Melanoma 1 Group	0
Melanoma 2 Group	0
Melanoma 3 Group	1
Melanoma 4 Group	0
Melanoma 5 Group	2
Melanoma 6 Group	0
Non-Small Cell Group	NA

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

Group	Value	95% CI
Melanoma 1 Group	4
Melanoma 2 Group	0
Melanoma 3 Group	4
Melanoma 4 Group	0
Melanoma 5 Group	4
Melanoma 6 Group	6
Melanoma 1 Group	9
Melanoma 2 Group	0
Melanoma 3 Group	7
Melanoma 4 Group	0
Melanoma 5 Group	3
Melanoma 6 Group	5
Melanoma 1 Group	0
Melanoma 2 Group	1
Melanoma 3 Group	2
Melanoma 4 Group	0
Melanoma 5 Group	4
Melanoma 6 Group	2
Melanoma 1 Group	1
Melanoma 2 Group	1
Melanoma 3 Group	1
Melanoma 4 Group	1
Melanoma 5 Group	1
Melanoma 6 Group	4

Number of Patients Responding to Treatment, by Best Clinical Response Type Primary · 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 t

Group	Value	95% CI
GS-positive Group	0
GS-negative Group	0
GS-invalid Group	0
GS-positive Group	1
GS-negative Group	0
GS-invalid Group	0
GS-positive Group	3
GS-negative Group	4
GS-invalid Group	1
GS-positive Group	9
GS-negative Group	4
GS-invalid Group	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Plasmacytoid dendritic cells at the forefront of anti-cancer immunity: rewiring strategies for tumor microenvironment remodeling.
   Monti M, Ferrari G, Gazzurelli L, Bugatti M, et al · · 2024 · cited 22× · PMID 39020402 · DOI 10.1186/s13046-024-03121-9