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NCT02178163Active, not recruiting

Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
619 (actual)
First submitted
26 Jun 2014
Start date
Aug 2014
Primary completion date
Jul 2027
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Diseases
Lung cancer
NCT number
NCT02178163

What you commit to

  • Study type: Interventional
  • Participants enrolled: 619
  • From Aug 2014 to the primary completion date, Jul 2027
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
KCI at McLaren Bay Region
Coordinator of this site? Confirm its status
Bay CityUnited StatesUnknown status
KCI at Mclaren Bloomfield Hills
Coordinator of this site? Confirm its status
Bloomfield HillsUnited StatesUnknown status
KCI At McLaren Clarkston
Coordinator of this site? Confirm its status
ClarkstonUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
KCI at McLaren Flint
Coordinator of this site? Confirm its status
FlintUnited StatesUnknown status
KCI at McLaren Greater Lansing, Mid Michigan Physicians
Coordinator of this site? Confirm its status
LansingUnited StatesUnknown status
KCI at McLaren Lapeer Region
Coordinator of this site? Confirm its status
LapeerUnited StatesUnknown status
KCI at McLaren Macomb
Coordinator of this site? Confirm its status
Mount ClemensUnited StatesUnknown status
KCI at McLaren Central Michigan
Coordinator of this site? Confirm its status
Mount PleasantUnited StatesUnknown status
KCI at Northern Michigan
Coordinator of this site? Confirm its status
PetoskeyUnited StatesUnknown status
KCI at McLaren Port Huron
Coordinator of this site? Confirm its status
Port HuronUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.