Personalized cancer care: genetic analysis may unlock targeted treatments for advanced lung cancer
NCT ID NCT02178163
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial investigates whether comprehensive genomic analysis of tumor tissue can help doctors choose targeted therapies for patients with advanced non-small cell lung cancer. Participants provide tumor samples (from past biopsies or new ones) for genetic testing. The goal is to see if this approach increases the number of patients who receive mutation-matched treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- comprehensive genomic analysis of tumor specimens
- What this could lead to
- If successful, this approach could help doctors select more effective, personalized treatments for advanced lung cancer based on each tumor's genetic profile.
- What could go wrong
- This is an early-stage observational study, not a treatment trial. It may not show that genomic-guided therapy improves outcomes, and some patients may not have actionable mutations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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619 people
The number who actually took part.
- Started
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Aug 2014
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 already undergone genomic analysis will be eligible. * 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 =\< 1.5 times the institutional upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) of \> 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 metastases and the managing physician believes that the elevation in liver enzymes is only related to the liver metastases * 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 obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site that has been radiated. * Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines Exclusion Criteria: * 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 hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible * 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 trial if they are pregnant; all sexually active patients will be informed that patients enrolling on a therapeutic trial have to use contraceptive methods to prevent pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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KCI At McLaren Clarkston
Clarkston, Michigan, 48346, United States
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KCI at McLaren Bay Region
Bay City, Michigan, 48708, United States
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KCI at McLaren Central Michigan
Mount Pleasant, Michigan, 48858, United States
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KCI at McLaren Flint
Flint, Michigan, 48532, United States
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KCI at McLaren Greater Lansing, Mid Michigan Physicians
Lansing, Michigan, 48910, United States
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KCI at McLaren Lapeer Region
Lapeer, Michigan, 48446, United States
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KCI at McLaren Macomb
Mount Clemens, Michigan, 48043, United States
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KCI at McLaren Port Huron
Port Huron, Michigan, 48060, United States
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KCI at Mclaren Bloomfield Hills
Bloomfield Hills, Michigan, 48302, United States
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KCI at Northern Michigan
Petoskey, Michigan, 49770, United States
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