Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

NCT ID: NCT02132884

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-08-31

Brief Summary

This randomized clinical trial studies how well genetic sequencing-informed targeted therapy works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify these specific types of tumor cells in patients with non-small cell lung cancer.

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.

Conditions

Malignant Pericardial Effusion; Malignant Pleural Effusion; Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (standard of care treatment)

Patients receive standard of care treatment based on the discretion of the treating physician.

Group Type: ACTIVE_COMPARATOR

therapeutic procedure

Intervention Type: PROCEDURE

Receive standard of care treatment

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

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.

Group Type: EXPERIMENTAL

cytology specimen collection procedure

Intervention Type: OTHER

Undergo collection of tissue and blood samples

targeted therapy

Intervention Type: DRUG

Receive specific targeted therapy

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

cytology specimen collection procedure

Undergo collection of tissue and blood samples

Intervention Type: OTHER

therapeutic procedure

Receive standard of care treatment

Intervention Type: PROCEDURE

targeted therapy

Receive specific targeted therapy

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

cytologic sampling; Therapeutic Interventions; Therapeutic Method; Therapeutic Technique; Therapy; TX

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hossein Borghaei

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2014-00717

Identifier Type: REGISTRY

Identifier Source: secondary_id

CGI-068

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CGI-068

Identifier Type: -

Identifier Source: org_study_id