Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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.

NCT ID: NCT02178163Sponsor: Barbara Ann Karmanos Cancer InstituteLast updated: 2025-07-25

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens. SECONDARY OBJECTIVES: I. To estimate the percentage of patients in whom genomic analysis can be performed. II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results. OUTLINE: Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.

Arms & interventions

  • Othercytology specimen collection procedure

    Correlative studies

  • Otherlaboratory biomarker analysis

    Correlative studies

Outcome measures

Primary

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

    Will be estimated with 95% confidence interval (CI) using the Wilson's method.

    Time frame: Up to 21 days

Secondary

  • Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1

    Time frame: Up to 2 years

  • Progression free survival (PFS)

    Time frame: Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years

  • Overall survival (OS)

    Time frame: From date of registration to up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (11)

KCI at McLaren Bay Region

Bay City, Michigan, 48708

Recruiting
· Contact

KCI at Mclaren Bloomfield Hills

Bloomfield Hills, Michigan, 48302

Recruiting
· Contact

KCI At McLaren Clarkston

Clarkston, Michigan, 48346

Recruiting
· Contact

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Gerold Bepler, M.D. · Contact
Gerold Bepler, M.D., PhD. · Principal Investigator
Ammar Sukari, M.D. · Sub Investigator
Hirva Mamdani, M.D. · Sub Investigator
Jonathan D. Abramson, M.D. · Sub Investigator
Shalini Thoutreddy, M.D. · Sub Investigator
Samir Alsawah, M.D. · Sub Investigator
Sai Bikkina, M.D. · Sub Investigator
Rana Bilbeisi, M.D, · Sub Investigator
Elena Coppola, M.D. · Sub Investigator
Salman Fateh, M.D. · Sub Investigator
Sandeep Grewal, M.D. · Sub Investigator
Youssef Hanna, M.D. · Sub Investigator
Christian Hyde, M.D. · Sub Investigator
Frank Knechtl, M.D. · Sub Investigator
Cheryl Kovalski, M.D. · Sub Investigator
Elizabeth Layhe, M.D. · Sub Investigator
Mohammed Masri, M.D. · Sub Investigator
Seraphim Pallas, M.D. · Sub Investigator
Anup Lal, M.D. · Sub Investigator
Dipesh Uprety, M.D. · Sub Investigator
Brooke Spencer (Trotter), M.D. · Sub Investigator
Numan Fateh, M.D. · Sub Investigator
Borys Hrinczenko, M.D. · Sub Investigator
Daniel Isaac, D.O. · Sub Investigator
Jatin Rana, M.D. · Sub Investigator
Ashley Matusz-Fisher, M.D. · Sub Investigator
Faras Alsawah, M.D. · Sub Investigator
Tarik Hadid, M.D. · Sub Investigator
Irene Connolly, M.D. · Sub Investigator
Orimisan Adekolujo, M.D. · Sub Investigator
Kalub Fedak, M.D. · Sub Investigator

KCI at McLaren Flint

Flint, Michigan, 48532

Recruiting
· Contact

KCI at McLaren Greater Lansing, Mid Michigan Physicians

Lansing, Michigan, 48910

Recruiting
· Contact

KCI at McLaren Lapeer Region

Lapeer, Michigan, 48446

Recruiting
· Contact

KCI at McLaren Macomb

Mount Clemens, Michigan, 48043

Recruiting
· Contact

KCI at McLaren Central Michigan

Mount Pleasant, Michigan, 48858

Recruiting
· Contact

KCI at Northern Michigan

Petoskey, Michigan, 49770

Recruiting
· Contact

KCI at McLaren Port Huron

Port Huron, Michigan, 48060

Recruiting
· Contact