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

NCT02132884 | Terminated Results DMC

• 3 other identifiers: CGI-068NCI-2014-00717P30CA006927
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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.

  Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months

Secondary Outcomes (2)

• Response Rate Defined by RECIST 1.1

  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

  Up to 2 years

Other Outcomes (4)

• Concordance of Variants (Arm B)

  Up to 2 years

• Incidence of Non-protocol Testing (Arm A)

  Up to 2 years

• Response Rate Defined by RECIST 1.1 (Arm A)

  Up to 2 years

Study Arms (2)

Arm A (standard of care treatment)

ACTIVE COMPARATOR

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

Procedure: therapeutic procedure; Other: laboratory biomarker analysis

Arm B (genetic sequencing and targeted therapy)

EXPERIMENTAL

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.

Other: cytology specimen collection procedure; Drug: targeted therapy; Other: laboratory biomarker analysis

Interventions

cytology specimen collection procedure OTHER

Undergo collection of tissue and blood samples

Also known as: cytologic sampling

Arm B (genetic sequencing and targeted therapy)

therapeutic procedure PROCEDURE

Receive standard of care treatment

Also known as: Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy, TX

Arm A (standard of care treatment)

targeted therapy DRUG

Receive specific targeted therapy

Arm B (genetic sequencing and targeted therapy)

laboratory biomarker analysis OTHER

Correlative studies

Arm A (standard of care treatment); Arm B (genetic sequencing and targeted therapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Coal Tar; Therapeutics

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Results Point of Contact

• Title: Dr. Hossein Borghaei
• Organization: Fox Chase Cancer Center

Hossein.Borghaei@fccc.edu

215-2141515

Study Officials

• Hossein Borghaei

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 4, 2019
• Results First Posted: January 16, 2018

Record last verified: 2019-08

Locations

US (1)