- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132884
Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
CancerCodeTM Informed, Molecularly Targeted Therapies in Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. The three month progression free survival (PFS) of patients treated with targeted agents in the second line setting based on the tumor molecular signature as defined by CancerCode will be 40% vs 20% with standard cytotoxic chemotherapy.
SECONDARY OBJECTIVES:
I. Response rate (RR). II. Overall survival (OS). III. Proportion of Arm-B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results.
IV. Concordance of variants identified when sequencing is performed on samples from the same patient collected at baseline and follow-up time points.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive standard of care therapy based on the discretion of the treating physician.
ARM B: Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC) - locally advanced, stage IIIB OR stage IV or stage IVM1A (malignant pleural or pericardial effusion or pleural implants) OR recurrence after primary surgery or radiotherapy (refer to 2010 American Joint Committee on Cancer [AJCC] staging, 7th edition [Ed])
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)-1.1 criteria; previous irradiated tumor is acceptable if there is at least a 20% increase in the size of the previously irradiated lesion
- Patients must be suitable candidates for treatment with standard regimens; this includes having adequate hematologic parameters, liver function and renal function based on labs that are deemed acceptable for treatment by the investigators
- Previous radiation allowed provided that 2 weeks has passed since radiation and/or the patient has recovered from the side effects
- Availability of archival diagnostic tissue (paraffin tissue block, cytospin block from a fine needle aspirate, or unstained slides from resected tumor, core biopsy, or fine needle aspirate) is required
- Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use effective methods of contraception during active treatment and for the duration of the study
Exclusion Criteria:
- Prior treatment with any investigational or targeted therapies
- Patients with known activating mutations in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma receptor tyrosine kinase (ALK) or c-ros oncogene 1, receptor tyrosine kinase (ROS-1) (this test [ROS-1] will be done only on select patients and at the discretion of treating physicians) translocation positive; the mutational status of all patients will be determined prior to study entry
- Prior malignancy within the past 3 years other than complete resection of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy
- Prior systemic therapy within 14 days of initiating protocol treatment
- Symptomatic brain metastasis or asymptomatic brain metastasis that are 1 cm or greater in size; patients with asymptomatic sub-centimeter brain metastasis are eligible
- Uncontrolled or unstable medical or psychiatric co-morbidities which would clearly limits patients participation
- Current, recent (within 2 weeks of enrollment of this study), or planned participation in an experimental drug study
- Unstable angina
- Pregnant (positive serum pregnancy test) or breast feeding
- History of any disease that could lead to impaired absorption of drugs
- Inability to comply with study and/or follow-up procedures
- Prior allogeneic bone marrow or organ
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A (standard of care treatment)
Patients receive standard of care treatment based on the discretion of the treating physician.
|
Correlative studies
Receive standard of care treatment
Other Names:
|
Experimental: Arm B (genetic sequencing and targeted therapy)
Patients undergo collection of tissue and blood samples for analysis via sequencing.
Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
|
Correlative studies
Undergo collection of tissue and blood samples
Other Names:
Receive specific targeted therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months
|
A chi-square test (one-sided; alpha = .1)
will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting.
For each patient "success" will be defined as being progression free for at least 3 months following initiation of second line therapy.
Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier.
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Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate Defined by RECIST 1.1
Time Frame: Up to 2 years
|
The response rate (with 95% two-sided confidence intervals) will be computed separately by arm.
One-sided chi-square or Fisher's exact tests (alpha = .1)
will be used to evaluate differences in response rates between arms.
|
Up to 2 years
|
Proportion of Arm B Patients Whose Second Line Therapy is Changed as a Result of Physician Access to CancerCode-50 Results
Time Frame: Up to 2 years
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To assess the effect of sequencing on clinical practice and decision making the proportion of Arm B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results will be computed.
This comparison will be based on information provided by the treating physician before being exposed to the sequencing results, and information obtained from a from post-treatment chart review.
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Up to 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance of Variants (Arm B)
Time Frame: Up to 2 years
|
The concordance of variants identified when sequencing will be performed on samples from the same patient collected at baseline and follow-up time points will also be measured.
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Up to 2 years
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Incidence of Non-protocol Testing (Arm A)
Time Frame: Up to 2 years
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The incidence of non-protocol testing of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.
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Up to 2 years
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Response Rate Defined by RECIST 1.1 (Arm A)
Time Frame: Up to 2 years
|
The response rate of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.
|
Up to 2 years
|
Progression Free Survival (Arm A)
Time Frame: Time from start of second line treatment to time of progression or death, whichever occurs first, assessed up to 2 year
|
The progression free survival of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.
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Time from start of second line treatment to time of progression or death, whichever occurs first, assessed up to 2 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hossein Borghaei, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Pleural Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Pleural Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Pleural Effusion, Malignant
- Pleural Effusion
- Pericardial Effusion
Other Study ID Numbers
- CGI-068 (Other Identifier: Fox Chase Cancer Center)
- P30CA006927 (U.S. NIH Grant/Contract)
- NCI-2014-00717 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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