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New treatment option for Recurrent Non-small Cell Lung Cancer
Official title Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT02178163
What this study is testing
- What it's testing
- This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and help doctors to tailor treatment to target the specific mutations.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival tissue for genomic analysis or are willing to undergo a new biopsy...
- Zubrod performance status 0-2
- Life expectancy \>= 3 months
- Absolute neutrophil count of \> 1.5 x 10\^9/L
- Platelet count \> 100,000 x 10\^9/L
You likely can't join if
- Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it...
- Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or...
- Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the...
See the full eligibility criteria
- Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival tissue for genomic analysis or are willing to undergo a new biopsy to obtain tumor tissue for genomic analysis. Patients whose tumor has...
- Zubrod performance status 0-2
- Life expectancy \>= 3 months
- Absolute neutrophil count of \> 1.5 x 10\^9/L
- Platelet count \> 100,000 x 10\^9/L
- Serum creatinine =\ 45 mL/min
- Serum bilirubin =\< 1.5 X ULN
- Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 times institutional ULN and alkaline phosphatase =\< 2.5 times ULN, unless patient has liver...
- Laboratory tests should be done within 30 days of enrollment on the trial
- A biopsy of the patient's tumor for genomic profiling is required; this biopsy specimen can be an already obtained diagnostic specimen provided the patient has not received systemic therapy since the biopsy has been...
- Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines
- Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
- Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active...
- Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the genomic analyses, that they may not be able to enroll on a clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Bay City, Michigan, United States
- Bloomfield Hills, Michigan, United States
- Clarkston, Michigan, United States
- Detroit, Michigan, United States
- Flint, Michigan, United States
- Lansing, Michigan, United States
- Lapeer, Michigan, United States
- Mount Clemens, Michigan, United States
- Mount Pleasant, Michigan, United States
- Petoskey, Michigan, United States
- Port Huron, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bay City, Michigan, United States; Bloomfield Hills, Michigan, United States; Clarkston, Michigan, United States; Detroit, Michigan, United States; Flint, Michigan, United States; Lansing, Michigan, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.