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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

Must not have

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 hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious illnesses like uncontrolled heart issues, recent heart attack, chronic hepatitis, HIV, or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients receiving therapy based on genomic analyses among all eligible patients

Secondary study objectives

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 • NCT02012296

76%

Fatigue

58%

Hot flashes

30%

Diarrhea

30%

Pain

27%

Hyperglycemia

24%

Back pain

18%

Nausea

18%

Dizziness

18%

Dyspnea

18%

Arthralgia

15%

Anorexia

15%

Depression

15%

Anxiety

15%

Hypertension

15%

Edema limbs

15%

Headache

15%

Pain in extremity

12%

Urinary frequency

12%

Constipation

12%

Cough

12%

Fall

12%

Abdominal pain

12%

Arthritis

12%

Bone pain

Urinary incontinence

Insomnia

Flank pain

Generalized muscle weakness

Genital edema

Hematuria

Memory impairment

Platelet count decreased

Pruritis

Anemia

Sinus disorder

Renal calculi

Confusion

Dyspepsia

Muscle weakness lower limb

Peripheral sensory neuropathy

Renal and urinary disorders - Other

Skin and subcutaneous tissue disorders - Other

Vomiting

Alkaline phosphatase increase

Blood bilirubin increased

Blurred vision

Skin infection

Alopecia

Cystitis noninfective

Fracture

General disorders and administration site conditions - Other

Hypokalemia

Upper respiratory infection

Weight gain

Infections and infestations - Other

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Enzalutamide)

Treatment (Enzalutamide, Mifepristone)

Not Randomized

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met