An interventional study of Collection of tumor and blood samples in Lung Cancer, Non-Small Cell, sponsored by GlaxoSmithKline. Terminated at 34 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Screening
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.
This protocol posting has been updated due to a protocol amendment.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 88 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cutaneous Melanoma, unresectable stage III or stage IV • The patient has histologically documented unresectable stage III or stage IV metastatic cutaneous melanoma.
AND
NSCLC, any stage if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection • The patient has NSCLC at any stage (as defined by the International Staging System) if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection.
AND
[Note: Induction radiotherapy is permitted.]
The recruitment of patients to the NSCLC group has been ended prematurely.
Exclusion Criteria:
Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment
Procedure: Collection of tumor and blood samples
Patients with cutaneous metastatic melanoma receiving first line treatment other than dacarbazine or temozolomide only
Procedure: Collection of tumor and blood samples
Patients with cutaneous metastatic melanoma receiving any second-or higherline chemotherapy treatment
Procedure: Collection of tumor and blood samples
Patients with cutaneous metastatic melanoma receiving local irradiation of cutaneous/subcutaneous tumor lesions
Procedure: Collection of tumor and blood samples
Patients with cutaneous metastatic melanoma receiving local imiquimod
Procedure: Collection of tumor and blood samples
Non-small cell lung cancer patients
Procedure: Collection of tumor and blood samples
Patients with cutaneous metastatic melanoma receiving ipilimumab
Procedure: Collection of tumor and blood samples
Samples will be collected before and after standard treatment
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
Time frame: 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.
Time frame: Before and after administration of standard of care treatment course, up to 3 months
The Serum Proteome
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 6 months after the initiation of the ipilimumab therapy
| Milestone | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group | Non-Small Cell Group |
|---|---|---|---|---|---|---|---|
| Started | 17 | 3 | 21 | 2 | 15 | 20 | 10 |
| Completed | 17 | 3 | 19 | 2 | 15 | 20 | 9 |
| Not completed | 0 | 0 | 2 | 0 | 0 | 0 | 1 |
| Withdrew: Tumor sampling failure | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Patient didn't receive the treatment | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Eligibility criteria not fulfilled | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
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
| Participants | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group | Non-Small Cell Group |
|---|---|---|---|---|---|---|---|
| MAGE-A3 — Remained Positive | 8 | 0 | 11 | 1 | 5 | 6 | 1 |
| MAGE-A3 — Remained negative | 7 | 0 | 0 | 0 | 5 | 6 | 5 |
| MAGE-A3 — Turned Positive | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| MAGE-A3 — Turned Negative | 0 | 2 | 9 | 0 | 2 | 3 | 2 |
| MAGE-A3 — Not tested | 1 | 0 | 0 | 1 | 2 | 1 | 0 |
| MAGE-A3 — Invalid testing | 1 | 1 | 1 | 0 | 0 | 3 | 2 |
| NY-ESO-01 — Remained Positive | 4 | 1 | 2 | 1 | 4 | 4 | NA |
| NY-ESO-01 — Remained negative | 9 | 1 | 14 | 0 | 6 | 11 | NA |
| NY-ESO-01 — Turned Positive | 1 | 0 | 1 | 0 | 1 | 1 | NA |
| NY-ESO-01 — Turned Negative | 0 | 0 | 1 | 0 | 2 | 0 | NA |
| NY-ESO-01 — Not tested | 2 | 0 | 2 | 1 | 2 | 1 | NA |
| NY-ESO-01 — Invalid testing | 1 | 1 | 1 | 0 | 0 | 3 | NA |
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.
| Participants | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group |
|---|---|---|---|---|---|---|
| Remained positive | 4 | 0 | 4 | 0 | 4 | 6 |
| Remained Negative | 9 | 0 | 7 | 0 | 3 | 5 |
| Turned Positive | 0 | 1 | 2 | 0 | 4 | 2 |
| Turned Negative | 1 | 1 | 1 | 1 | 1 | 4 |
| Not tested | 2 | 0 | 6 | 1 | 3 | 0 |
| Invalid testing | 1 | 1 | 1 | 0 | 0 | 3 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
| Participants | GS-positive Group | GS-negative Group | GS-invalid Group |
|---|---|---|---|
| Complete response | 0 | 0 | 0 |
| Partial response | 1 | 0 | 0 |
| Stable Disease | 3 | 4 | 1 |
| Progressive Disease | 9 | 4 | 0 |
| Not evaluable | 1 | 2 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Melanoma 1 Group | — | — | — |
| Melanoma 2 Group | — | — | — |
| Melanoma 3 Group | — | — | — |
| Melanoma 4 Group | — | — | — |
| Melanoma 5 Group | — | — | — |
| Melanoma 6 Group | — | — | — |
| Non-Small Cell Group | — | — | — |
| Age, Continuous(Years) | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group | Non-Small Cell Group | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 67.4 ± 12.1 | 50.7 ± 12.5 | 64.5 ± 11.5 | 77.0 ± 5.7 | 65.5 ± 13.5 | 61.8 ± 16.7 | 59.5 ± 9.7 | 63.8 ± 13.3 |
| Sex: Female, Male(Participants) | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group | Non-Small Cell Group | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 11 | 3 | 9 | 0 | 9 | 11 | 2 | 45 |
| Male | 6 | 0 | 12 | 2 | 6 | 9 | 8 | 43 |
| Race and Ethnicity Not Collected(Participants) | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group | Non-Small Cell Group | Total |
|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | 0 |
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline