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Genomic Analysis
Genomic Analysis for Advanced Lung Cancer
N/A
Recruiting
Led By Gerold Bepler, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site that has been radiated.
Zubrod performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will analyze the DNA of patients with stage IV lung cancer to look for mutations. If they find any, they will then try to tailor treatment to target those mutations.
Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer who have a life expectancy of at least 3 months and are in relatively good health. They must not have had recent serious heart issues, active hepatitis, HIV, or other cancers that could affect the outcome. Pregnant women are excluded.Check my eligibility
What is being tested?
The study involves collecting tissue samples from patients to perform comprehensive genomic analysis. This may help identify specific DNA mutations in the cancer cells and allow doctors to customize treatments targeting these mutations.See study design
What are the potential side effects?
Since this trial focuses on genomic analysis rather than treatment intervention, it does not involve direct side effects like those associated with medications or therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a recent biopsy (not from a radiated site) that hasn't been followed by systemic therapy.
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I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have stage IV or recurrent NSCLC and can provide tissue for genomic analysis.
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My kidney function, measured by creatinine levels, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients receiving therapy based on genomic analyses among all eligible patients
Secondary outcome measures
Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1
Overall survival (OS)
Progression free survival (PFS)
Side effects data
From 2020 Phase 1 & 2 trial • 88 Patients • NCT0201229682%
Fatigue
45%
Hot flashes
42%
Anorexia
39%
Constipation
27%
Pain
27%
Generalized muscle weakness
21%
Back pain
18%
Diarrhea
18%
Headache
18%
Hypertension
18%
Dizziness
18%
Nausea
15%
Weight loss
15%
Arthralgia
15%
Upper respiratory infection
12%
Abdominal pain
12%
Memory impairment
12%
Peripheral sensory neuropathy
12%
Hematuria
12%
Vomiting
12%
Fall
12%
Pain in extremity
12%
Urinary frequency
9%
Dyspnea
9%
Pelvic pain
9%
Hyperglycemia
9%
General disorders and administration site conditions - Other
9%
Anxiety
9%
Edema limbs
6%
White blood cell decreased
6%
Breast pain
6%
Alopecia
6%
Ear pain
6%
Flank pain
6%
Urinary incontinence
6%
Renal and urinary disorders - Other
6%
Investigations - Other
6%
Cystitis noninfective
6%
Fracture
6%
Hypokalemia
6%
Weight gain
6%
Watering eyes
6%
Paresthesia
6%
Neoplasms benign, malignant and unspecified
6%
Flu like symptoms
6%
Arthritis
6%
Bone pain
6%
Cough
6%
Urinary retention
3%
Neutrophil count decreased
3%
Small intestinal obstruction
3%
Depression
3%
Dyspepsia
3%
Platelet count decreased
3%
Confusion
3%
Ileus
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin infection
3%
Non-cardiac chest pain
3%
Blurred vision
3%
Muscle weakness lower limb
3%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzalutamide, Mifepristone)
Treatment (Enzalutamide)
Not Randomized
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ancillary-Correlative (comprehensive genomic analysis)Experimental Treatment2 Interventions
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy.
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
8,236 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,930,730 Total Patients Enrolled
Gerold Bepler, M.D.Principal Investigator - Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Hospital, Barbara Ann Karmanos Cancer Institute, DMC Harper University Hospital, DMC Hutzel Women's Hospital
Philipps-University (Medical School)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your absolute neutrophil count is higher than 1.5 x 10^9/L.I have a recent biopsy (not from a radiated site) that hasn't been followed by systemic therapy.My liver function tests are within acceptable limits, or any high results are due to liver cancer.I can take care of myself and am up and about more than 50% of my waking hours.I have another cancer, but my doctor thinks it won't affect this treatment.I am not pregnant or breastfeeding and willing to use birth control if I join the trial.I do not have serious illnesses like uncontrolled heart issues, recent heart attack, chronic hepatitis, HIV, or active infections.Your platelet count is higher than 100,000 per microliter of blood.I have stage IV or recurrent NSCLC and can provide tissue for genomic analysis.Your bilirubin levels in the blood are not higher than 1.5 times the upper limit of normal.You are expected to live for at least 3 more months.My kidney function, measured by creatinine levels, is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Ancillary-Correlative (comprehensive genomic analysis)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor accepting volunteers?
"Affirmative, the statistics on clinicaltrials.gov confirms that this experiment is presently recruiting volunteers. It was first announced in June 2014 and last edited in late September 2022 with a target of 96 participants from 3 different medical centres."
Answered by AI
What is the highest capacity of participants for this experiment?
"Affirmative, the evidence on clinicaltrials.gov proves that this research endeavour is accepting enrolments. This trial was initially made available to prospective participants on June 1st 2014 and has since been updated as recently as September 22nd 2022. 96 patients must be recruited from 3 different locations for the study to proceed."
Answered by AI
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