Lung Cancer, Non-Small Cell, Neoplasms
Conditions
Keywords
Tumor biopsy, Molecular Disease Characterization Initiative, Oncology, Clinical trial
Brief summary
This is a single arm interventional molecular analysis study with no administration of investigational product and no masking. This multicenter study will involve participants with advanced/metastatic disease for the purpose of collecting tumor tissue and blood samples for broad molecular analysis and examining the expression of specific biomarkers using validated clinical assays.
Interventions
PROCEDURETumor biopsy
Archived or fresh tumor biopsy samples will be collected.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is a candidate for molecular screening for a GlaxoSmithKline (GSK) precision therapeutic clinical study (the Intended Treatment Protocol) that is being conducted in parallel at or nearby the MDCI recruitment site. * Participant is willing to travel to a site recruiting for the intended GSK treatment protocol (or alternative treatment protocol), if feasible, and if, in the investigator's opinion, the participant would benefit from enrolment into the intended GSK treatment protocol at an alternative clinical site. * Participants with confirmed advanced/metastatic diagnosis of solid malignancy in one of the following disease-areas: Non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Breast, ovarian, and colorectal cancer (CRC). * Participants with life expectancy of greater than (\>) 6 months. * Participants who are able to provide blood samples. * Participants who are able to provide an archival formalin-fixed paraffin-embedded (FFPE) tumor specimen from a current lesion/most current setting (from no more than 2 years ago). If an archival tumor specimen is not available, surplus tissue from standard of care procedures is acceptable before fresh biopsy may be obtained. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than \[\<\]1 percent \[%\] per year), preferably with low user dependency; A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) as required by local regulations) within 24 hours before tumor biopsy; and if a urine test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Exclusion criteria
* Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status \>2. * Participants with history of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months. * For female participants, pregnancy. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with the participant's safety, obtaining informed consent or compliance to the screening study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Inducible T-cell Co-Stimulator (ICOS) Status | Up to approximately 17 months | Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The ICOS is the biomarkers and data for participants with its positive status has been presented. |
| Number of Participants With Positive New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1)/Cancer Testis Antigen 2 (LAGE-1a) Status | Up to approximately 17 months | Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The NY-ESO-1 and LAGE-1a are biomarker and data for number of participants with its positive status has been presented. |
| Number of Participants With Positive Programmed Death Protein 1 Ligand (PD-L1) Status | Up to approximately 17 months | Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The PD-L1 is a biomarker and data for number of participants with its positive status has been presented. |
Countries
Spain, United States
Participant flow
Recruitment details
The study was terminated for reasons pertaining to feasibility.
Participants by arm
| Arm | Count |
|---|---|
| Participants Who Underwent Tumor Biopsy Participants with advanced/metastatic diagnosis of malignancy disease underwent tumor biopsy. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Study Terminated by Sponsor | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Participants Who Underwent Tumor Biopsy |
|---|---|
| Age, Continuous | 58.2 YEARS STANDARD_DEVIATION 9.85 |
| Race/Ethnicity, Customized White | 6 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Primary
Number of Participants With Positive Inducible T-cell Co-Stimulator (ICOS) Status
Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The ICOS is the biomarkers and data for participants with its positive status has been presented.
Time frame: Up to approximately 17 months
Population: Enrolled population included all participants who signed the informed consent form (ICF) and met inclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Underwent Tumor Biopsy | Number of Participants With Positive Inducible T-cell Co-Stimulator (ICOS) Status | 2 Participants |
Primary
Number of Participants With Positive New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1)/Cancer Testis Antigen 2 (LAGE-1a) Status
Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The NY-ESO-1 and LAGE-1a are biomarker and data for number of participants with its positive status has been presented.
Time frame: Up to approximately 17 months
Population: Enrolled population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Underwent Tumor Biopsy | Number of Participants With Positive New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1)/Cancer Testis Antigen 2 (LAGE-1a) Status | 1 Participants |
Primary
Number of Participants With Positive Programmed Death Protein 1 Ligand (PD-L1) Status
Blood samples were collected for clinical biomarker testing and a tumor specimen was collected as per tumor specimen collection requirements. The specimen was evaluated by immunohistochemistry (IHC) to determine the expression of tumor specific antigens and immune markers. The PD-L1 is a biomarker and data for number of participants with its positive status has been presented.
Time frame: Up to approximately 17 months
Population: Enrolled population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Underwent Tumor Biopsy | Number of Participants With Positive Programmed Death Protein 1 Ligand (PD-L1) Status | 0 Participants |