Actively Recruiting
A Study to Assess Therapy Initiation in Advanced Non-small Cell Lung Cancer Patients Based on Genomic Tumor Analysis
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-07-25
1020
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has returned or is at stage IV. This analysis aims to identify specific gene changes that may help doctors tailor treatments to target those changes. The study also assesses how often therapy can be started based on these genomic results and examines patient outcomes such as progression-free survival and response rates. Participants provide tissue samples for genomic analysis using methods like mass spectrometry, PCR, and microarray. Based on the analysis, patients may begin targeted therapy. After treatment, patients are followed every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter to monitor their progress. During the study, patients undergo tissue collection and genomic testing, followed by potential therapy initiation. Researchers track the proportion of patients receiving therapy based on genomic results within 21 days. They also evaluate response rates, progression-free survival, and overall survival over up to 2 years. Safety and health status are monitored throughout the follow-up period.
CONDITIONS
Brief Title
Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with stage IV or recurrent non-small cell lung cancer
- Have archival tumor tissue or willing to undergo a biopsy for genomic analysis
- Patients whose tumor has already undergone genomic analysis are eligible
- Zubrod performance status between 0 and 2
- Life expectancy of at least 3 months
- Absolute neutrophil count greater than 1.5 x 10^9/L
- Platelet count greater than 100,000 x 10^9/L
- Serum creatinine less than or equal to 1.5 times institutional upper limit or creatinine clearance over 45 mL/min
- Serum bilirubin less than or equal to 1.5 times institutional upper limit
- Liver enzymes (SGOT, SGPT) and alkaline phosphatase less than or equal to 2.5 times institutional upper limit unless related to liver metastases
- Laboratory tests performed within 30 days before enrollment
- Biopsy specimen for genomic profiling obtained within 60 days and not from a radiated tumor site
- Signed informed consent according to institutional and federal guidelines
You will not qualify if you...
- Patients with concurrent malignancy likely to impact clinical outcome
- Serious uncontrolled medical illnesses including congestive heart failure, angina, recent heart attack or stroke within 6 months
- History of chronic active hepatitis or human immunodeficiency virus (HIV)
- Active bacterial infection
- Pregnant or breastfeeding women
- Female patients of childbearing potential who do not use contraceptive methods if enrolling on therapeutic trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants undergo collection of tissue samples for genomic analysis using mass spectrometry, PCR, and microarray. Based on the results, participants may begin therapy.
1 visit (in-person) for sample collection
Duration - Varies based on therapy initiation and progression
Participants who start therapy based on genomic analysis results receive treatment aimed at managing advanced non-small cell lung cancer.
Visit schedule determined by treating physician
Duration - Up to 5 years
After completion of study treatment, participants are followed to monitor overall response, progression-free survival, and overall survival.
Every 3 months for 2 years, every 6 months for 3 years, then annually thereafter
Trial Site Locations
Total: 11 locations
1
KCI at McLaren Bay Region
Bay City, Michigan, United States, 48708
Actively Recruiting
2
KCI at Mclaren Bloomfield Hills
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
3
KCI At McLaren Clarkston
Clarkston, Michigan, United States, 48346
Actively Recruiting
4
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
5
KCI at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
6
KCI at McLaren Greater Lansing, Mid Michigan Physicians
Lansing, Michigan, United States, 48910
Actively Recruiting
7
KCI at McLaren Lapeer Region
Lapeer, Michigan, United States, 48446
Actively Recruiting
8
KCI at McLaren Macomb
Mount Clemens, Michigan, United States, 48043
Actively Recruiting
9
KCI at McLaren Central Michigan
Mount Pleasant, Michigan, United States, 48858
Actively Recruiting
10
KCI at Northern Michigan
Petoskey, Michigan, United States, 49770
Actively Recruiting
11
KCI at McLaren Port Huron
Port Huron, Michigan, United States, 48060
Actively Recruiting
Research Team
G
Gerold Bepler, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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