Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02178163 |
Recruitment Status :
Recruiting
First Posted : June 30, 2014
Last Update Posted : August 15, 2023
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Condition or disease | Intervention/treatment | Phase |
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Recurrent Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | Other: cytology specimen collection procedure Other: laboratory biomarker analysis | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1020 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | This study will assess the percentage of advanced NSCLC patients whose tumor samples can undergo genomic analysis and in whom therapy can begin based on the results of this analysis. |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | 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. |
Study Start Date : | June 2014 |
Estimated Primary Completion Date : | July 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Ancillary-Correlative (comprehensive genomic analysis)
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.
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Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling Other: laboratory biomarker analysis Correlative studies |
- Proportion of patients receiving therapy based on genomic analyses among all eligible patients [ Time Frame: Up to 21 days ]Will be estimated with 95% confidence interval (CI) using the Wilson's method.
- Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 2 years ]Response rate will be estimated with 95% Wilson's CI.
- 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 ]PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
- Overall survival (OS) [ Time Frame: From date of registration to up to 2 years ]Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178163
Contact: Gerold Bepler, M.D. | (313) 576-8665 |
United States, Michigan | |
KCI at McLaren Bay Region | Recruiting |
Bay City, Michigan, United States, 48708 | |
Contact 800-527-6266 | |
KCI at Mclaren Bloomfield Hills | Active, not recruiting |
Bloomfield Hills, Michigan, United States, 48302 | |
KCI At McLaren Clarkston | Recruiting |
Clarkston, Michigan, United States, 48346 | |
Contact 800-527-6266 | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Gerold Bepler, M.D. 800-527-6266 beplerg@karmanos.org | |
Principal Investigator: Gerold Bepler, M.D., PhD. | |
Sub-Investigator: Ammar Sukari, M.D. | |
Sub-Investigator: Hirva Mamdani, M.D. | |
Sub-Investigator: Alicia Bolling-Fischer, M.D. | |
Sub-Investigator: Jonathan D. Abramson, M.D. | |
Sub-Investigator: Shalini Thoutreddy, M.D. | |
Sub-Investigator: Samir Alsawah, M.D. | |
Sub-Investigator: Maden Arora, M.D. | |
Sub-Investigator: Sai Bikkina, M.D. | |
Sub-Investigator: Rana Bilbeisi, M.D, | |
Sub-Investigator: Aliccia Bollig-Fischer, 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: Stephanie Leslie, M.D. | |
Sub-Investigator: Sharon Levandowski, M.D. | |
Sub-Investigator: Mohammed Masri, M.D. | |
Sub-Investigator: Seraphim Pallas, M.D. | |
Sub-Investigator: Trevor Singh, M.D. | |
Sub-Investigator: David Eilender, M.D. | |
Sub-Investigator: Ronald Kauwachi, M.D. | |
Sub-Investigator: Anteneh Tesfaye, M.D. | |
Sub-Investigator: Faheem Ahmed, M.D. | |
Sub-Investigator: Usha Sree Chamarthy, M.D. | |
Sub-Investigator: Haitham Al-Okk, 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. | |
KCI at McLaren Flint | Recruiting |
Flint, Michigan, United States, 48532 | |
Contact 800-527-6266 | |
KCI at McLaren Lapeer Region | Recruiting |
Lapeer, Michigan, United States, 48446 | |
Contact 800-527-6266 | |
KCI at McLaren Macomb | Recruiting |
Mount Clemens, Michigan, United States, 48043 | |
Contact 800-527-6266 | |
KCI at McLaren Central Michigan | Recruiting |
Mount Pleasant, Michigan, United States, 48858 | |
Contact 800-527-6266 | |
KCI at Northern Michigan Petoskey | Recruiting |
Petoskey, Michigan, United States, 49770 | |
Contact 800-527-6266 | |
KCI at McLaren Port Huron | Recruiting |
Port Huron, Michigan, United States, 48060 | |
Contact 800-527-6266 |
Principal Investigator: | Gerold Bepler, M.D. | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Gerold Bepler, Principal Investigator, Barbara Ann Karmanos Cancer Institute |
ClinicalTrials.gov Identifier: | NCT02178163 |
Other Study ID Numbers: |
2014-002 NCI-2014-00913 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) W81XWH-11-1-0500 ( Other Identifier: Dept of Defense ) 2014-002 ( Other Identifier: Barbara Ann Karmanos Cancer Institute ) P30CA022453 ( U.S. NIH Grant/Contract ) |
First Posted: | June 30, 2014 Key Record Dates |
Last Update Posted: | August 15, 2023 |
Last Verified: | August 2023 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |