The patients are given the opportunity to read the informed consent document and are given a chance to ask questions. If they wish to participate the patient will then sign the informed consent document in the presence of a witness. The study team member who participates in the informed consent process also documents, in a clinic note, the nature of the consent process that occurred. Protocol Version 8.0. September 19 , 2018 Page | 58 10.3 Protection Against Risk To protect participants from excess risk, the above -mentioned study procedures and dose - escalation scheme were instituted. Additional protection is provided through the data safety and monitoring plan described below. The complete care of each patient, including the clinical management of all toxicities, is provided to the patient by physicians at the Moffitt Cancer Center. The clinical data are kept in the patient's individual electronic hospital record. Research study documentation charts are kept in a locked secure room with limited access and through Oncore (a Web-based, password -protected database), with privacy protected to the full extent of the law. Authorized research investigators, the Department of Health and Human Services, and the Institutional Review Board may inspect the records. Final protocol and ICF approvals will be obtained from the IRB. Additional protection is provided in the data safety and monitoring plan described below. 10.4 Importance of the Knowledge to be Gained The development of a well -tolerated and effective regimen in a disease could potenti ally at worst add to the armamentarium of available regimens and at best change standard of care. Specific strategies to improve the care of patients relapsing following chemotherapy for lung cancer are direly needed. 10.5 Data Safety and Monitoring Plan The Data Safety & Monitoring Plan (DSMP) will ensure that this trial is well designed, responsibly managed, appropriately reported, and that it protects the rights and welfare of patients. The following internal and external review and monitoring processes pr ovide oversight and active monitoring of this trial: • The Principal Investigators (PI) • The Clinical Trials Office (CTO) • The Scientific Review Committee (SRC) • The Protocol Monitoring Committee (PMC); • The Research Compliance Division (RCD) of the Cancer Cente r's Compliance Office; • Institutional Review Board (IRB). The protocol includes a section that specifies the following with respect to Adverse Event reporting: what constitutes an adverse event (versus what is a serious adverse event), the entities to whic h adverse events should be reported, the timing of this reporting, and the person or persons responsible for reporting. This includes prompt (within one day of knowledge of the event) reporting to the IRB for unanticipated risks to subjects and reporting in writing within five working days to the IRB and sponsor. 10.6 Scientific Review Committee (SRC) The two Therapeutic boards of the SRC meet every other week one on the first Wednesday and the second one meets on the third Thursday of every month. Each SRC conducts a formal internal peer review of all clinical protocols and general scientific oversight of interventional clinical research. Protocols are reviewed for scientific Protocol Version 8.0. September 19 , 2018 Page | 59 merit, adequate study design, safety, availability of targeted study population, and feasibility of timely completion of all proposed research projects to be conducted by its assigned programs at each Cancer Center. The SRC is responsible for evaluating the risk/benefit assessment and corresponding data and safety monitoring pl an as part of the scientific review and approval process. 10.7 PI Responsibility The PI of each study is ultimately responsible for every aspect of the design, conduct and actions of all members of the research team. This includes the final analysis of the protocol. All protocols include a DSMP and procedures for its implementation commensurate with the risk and complexity of the study. The DSMP must include a structured adverse event determination, monitoring and reporting system, including standardized forms and procedures for referring and/or treating subjects experiencing adverse events. The plan must include data and safety -monitoring procedures for subjects enrolled who may be receiving a part of their protocol- required treatment at community sites. In all cases, the PI of the study will have primary responsibility for ensuring that the protocol is conducted as approved by the SRC and IRB. The PI will ensure that the monitoring plan is followed, that all data required for oversight of monitoring ar e accurately reported to a DSMB and/or to the PMC and IRB as required, that all adverse events are reported according to protocol guidelines, and that any adverse actions reflecting patient safety concerns are appropriately reported. 10.8 The Protocol Monitoring Committee (PMC) The PMC meets once a month. The PMC reviews and evaluates safety and/or efficacy data for all physician authored clinical intervention trials. The PMC ensures the safety of patients and the validity and integrity of data. PMC reviews SA Es, deviations, Interim analysis, interim and final reports from the external Data Monitoring Committee (DMC) as well as audits both internally and externally. The PMC can make the following determinations, Accepted, Acceptable with Corrective Action and T abled. Investigators of studies, which are designated to be reviewed by the PMC for data and safety monitoring, shall provide an interim analysis report of the study’s progress and summary of adverse events and deviations based on the phase of the study and the associated risk of the study or more often if applicable. The external DSMB (if applicable) shall forward its report for high -risk studies designated for external review at least annually or more often if applicable. 10.9 Suspension/Termination The PMC and/or the IRB may vote to suspend or terminate approval of a research study not being conducted in accordance with the IRB, the Cancer Center and/or regulatory requirements or that has been associated with unexpected problems or serious harm to subjects. The PMC/IRB will notify the PI in writing of such suspension or terminations. It is the responsibility of the PMC/IRB Chairperson to ensure prompt written notification of any suspensions or terminations of PMC/IRB approval to the relevant Federal Agencies, Protocol Version 8.0. September 19 , 2018 Page | 60 including OHRP, FDA, the study sponsor/funding source and if applicable, the Affiliate Program. 10.10 Monitoring of the Study and Regulatory Compliance The Principal Investigator and the Clinical Research Coordinator assigned to the case will be primarily responsible for maintaining all study related documents including the clinical research forms. Oncore is the database of record for all CRF entries and will be verified with source documentation. The review of medical records within PowerChart will be done in a manner to assure that patient confidentiality is maintained. 10.11 Internal Monitoring Plan Data will be captured in Oncore, Moffitt’s Clinical Trials Database. Regulatory documents and case report forms will be reviewed routinely by the MCC Clinical Research Monitoring Core for accuracy, completeness and source verification of data entry, validation of appropriate informed consent process, adherence to study procedures, and reporting of SAEs and protocol deviations according to MCC Monitoring Policies. 10.12 Protocol Modifications No modifications will be made to the protocol without the agreement of the investigators. Changes that significantly affect the safety of t he patients, the scope of the investigation, or the scientific quality of the study will require Scientific Review Committee and Institutional Review Board approval prior to implementation, except where the modification is necessary to eliminate apparent immediate hazard to human subjects. Any departures from the protocol must be fully documented in the case report form and the source documentation. 10.13 The Institutional Review Board (IRB) The trial will not be initiated without approval of the appropriate Institutional Review Board (IRB). All administrative requirements of the governing body of the institution will be fully complied with. This protocol, consent procedures, and any amendments must be approved by the IRB in compliance with current regulations of the Food and Drug Administration. A letter of approval will be sent to the institution(s) funding the study prior to initiation of the study and when any subsequent modifications are made. The IRB will be kept informed by the investigator as to the progress of the study as well as to any serious or unusual adverse events. 10.14 Patient Privacy In order to maintain patient confidentiality, all case report forms, study reports and communications relating to the study will identify patients by initials and assigned patient numbers. The US Food and Drug Administration (FDA) may also request access to all study records, including source documentation for inspection. 10.15 Records Retention U.S. FDA regulations (21 CFR §312.62[c]) require that records and documents pertaining to the conduct of this study and the distribution of investigational drug, including CRFs, Protocol Version 8.0. September 19 , 2018 Page | 61 consent forms, laboratory test results, and medication inventory records, must be retained by the Principal Investigator for 2 years after marketing applic ation approval. If no application is filed, these records must be kept 2 years after the study is discontinued and the U.S. FDA and the applicable national and local health authorities are notified. 10.16 Compliance with Trial Registration and Results Posting Requirements Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food and Drug Administration Amendments Act (FDAAA), the Sponsor of the trial is solely responsible for determining whether the trial and its results are subject to the requirements for submission to the Clinical Trials Data Bank, http://www.clinicaltrials.gov. Information posted will allow subjects to identify potentially appropriate trials for their disease conditions and pursue participation by calling a central contact number for further information on appropriate trial locations and trial site contact information.