Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017
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Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017 Pilot Study of Local Therapies for Oligometastatic Non-Small Cell Lung Cancer harboring Sensitizing EGFR Mutations PROTOCOL FACE PAGE FOR MSKCC THERAPEUTIC/DIAGNOSTIC PROTOCOL Principal Investigator/Department: Helena Yu MD Medicine Co-Principal Abraham Wu MD Radiation Oncology Investigator(s)/Department: James Huang MD Surgery Steven Solomon, MD Radiology Investigator(s)/Department: Jamie Chaft, MD Medicine Alexander Drilon, MD Medicine Mark Kris, MD Medicine Paul Paik, MD Medicine Charles Rudin, MD, PhD Medicine Stephen Veach, MD Medicine Marjorie Zauderer, MD Medicine Matthew Hellmann, MD Medicine Gregory Riely, MD Medicine Bob Li, MD Medicine Robert Daly, MD Medicine Piro Lito, MD PhD Medicine Leslie Tyson, NP Nursing Karen Lee, NP Nursing Linda Ahn, NP Nurisng Elizabeth Panora, NP Nursing Alison Massey, NP Nursing Maureen Kennedy, RN Nursing Afsheen Iqbal, MD Medicine Han Xiao, MD Medicine Sree Chalasani, MD Medicine Leticia Smith, APN Nursing Janet Cogswell, CRN Nursing John Fiore, MD Medicine Juliana Eng, MD Medicine Jahan Aghalar, MD Medicine Avni Desai, MD Medicine Stuart Lichtman, MD Medicine Jia Li, MD Medicine Wanqing Iris Zhi, MD PhD Medicine Lori Gofter, CRN Nursing Page 1 of 33 Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017 Kenneth Ng, MD Aryln Medicine Apollo, MD Pamela Medicine Drullinsky, MD Zoe Medicine Goldberg, MD Medicine Tiffany Troso-Sandoval, MD Medicine Erin Scansarole, CRN Nursing Krysti Corrado, CRN Nursing Alice Zervoudakis, MD Medicine Parisa Momtaz, MD Medicine Daniel McFarland, DO Medicine Gloria Wasilewski, CRN Nursing Jason Konner, MD Medicine Serena Wong, MD Medicine Jacqueline Bromberg, MD PhD Medicine Azadeh Namakydoust, MD Medicine Colette Owens, MD Medicine Loren Michel, MD Medicine Marina Shcherba, DO Medicine Kaitlin Woo, MS Biostatistics Viviane Tabar, MD Neurosurgery Peter Kingham MD Surgery Vivian Strong MD Surgery Prasad Adusumilli, MD Surgery Manjit Bains, MD Surgery Robert Downey, MD Surgery David Jones, MD Surgery Bernard Park, MD Surgery Valerie Rusch, MD Surgery Matt Bott, MD Surgery Daniela Molena, MD Surgery James Huang, MD Surgery Matthew Bott, MD Surgery James Isbell, MD Surgery Andreas Rimner, MD Radiation Oncology Timothy Chan, MD PhD Radiation Oncology Kathryn Beal, MD Radiation Oncology Yoshiya Yamada, MD Radiation Oncology Sean McBride, MD Radiation Oncology Adam Schmitt, MD Radiation Onoclogy Page 2 of 33 Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017 Karen Borofsky, MD Radiation Oncology Karen Schupak, MD Radiation Oncology Preeti Parhar, MD Radiation Oncology Melissa Zinovoy, MD Radiation Oncology Daphna Gelblum, MD Radiation Oncology Marsha Reyngold, MD PhD Radiation Oncology Jillian Tsai, MD PhD Radiation Oncology Richard Gewanter, MD Radiation Oncology Pinaki Dutta, MD PhD Radiation Oncology Borys Mychalczak, MD Radiation Oncology Boris Mueller, MD Radiation Oncology Annemarie Sheperd, MD Radiation Oncology Carla Hajj, MD Radiation Oncology John Cuaron, MD Radiation Oncology James Lee, MD Radiation Oncology Lior Braunstein, MD Radiation Oncology Nancy Lee, MD Radiation Oncology Beryl McCormick, MD Radiation Oncology Sara Hayes, MD Radiology Andrew Plodkowski, MD Radiology Etay Ziv, MD Radiology Joseph Erinjeri, MD, PhD Radiology William Alago, Jr., MD Radiology Marc Ladanyi MD Pathology Consenting Professional(s)/Department: Helena Yu, MD Medicine Jamie Chaft, MD Medicine Alexander Drilon, MD Medicine Mark Kris, MD Medicine Paul Paik, MD Medicine Charles Rudin, MD, PhD Medicine Stephen Veach, MD Medicine Marjorie Zauderer, MD Medicine Matthew Hellmann, MD Medicine Gregory Riely, MD Medicine Bob Li, MD Medicine Robert Daly, MD Medicine Piro Lito, MD PhD Medicine Han Xiao, MD Medicine Afsheen Iqbal, MD Medicine Sree Chalasani, MD Medicine Page 3 of 33 Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017 John Fiore, MD Medicine Juliana Eng, MD Medicine Jahan Aghalar, MD Medicine Avni Desai, MD Medicine Juliana Eng, MD Medicine Stuart Lichtman, MD Medicine Wanqing Iris Zhi, MD PhD Medicine Kenneth Ng, MD Arlyn Medicine Apollo, MD Pamela Medicine Drullinsky, MD Zoe Medicine Goldberg, MD Medicine Tiffany Troso-Sandoval, MD Medicine Parisa Momtaz, MD Medicine Daniel McFarland, DO Medicine Alice Zervoudakis, MD Medicine Jason Konner, MD Medicine Serena Wong, MD Medicine Jacqueline Bromberg, MD PhD Medicine Azadeh Namakydoust, MD Medicine Colette Owens, MD Medicine Loren Michel, MD Medicine Marina Shcherba, DO Medicine Please Note: A Consenting Professional must have completed the mandatory Human Subjects Education and Certification Program. One MSK Sites Manhattan Monmouth Westchester Basking Ridge Rockville Centre Commack Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, New York 10065 Page 4 of 33 Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017 Table of Contents 1.0 PROTOCOL SUMMARY AND/OR SCHEMA ..................................................................... 6 2.0 OBJECTIVES AND SCIENTIFIC AIM S .............................................................................. 7 3.0 BACKGROUND AND RATIONALE ................................................................................... 8 4.0 OVERVIEW OF STUDY DESIGN/INTERVENTION.......................................................... 11 4.1 Design........................................................................................................................... 11 4.2 Intervention ................................................................................................................... 11 5.0 THERAPEUTIC/DIAGNOSTIC AGENTS ......................................................................... 11 6.0 CRITERIA FOR SUBJECT ELIGIBILITY ......................................................................... 13 6.1 Subject Inclusion Criteria............................................................................................... 13 6.2 Subject Exclusion Criteria ............................................................................................. 14 7.0 RECRUITMENT PLAN ..................................................................................................... 14 8.0 PRETREATMENT EVALUATION .................................................................................... 15 9.0 TREATMENT/INTERVENTION PLAN.............................................................................. 15 10.0 EVALUATION DURING TREATMENT/INTERVENTION ................................................. 17 11.0 TOXICITIES/SIDE EFFECTS ........................................................................................... 18 12.0 CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOM E ASSESSMENT ..................... 22 13.0 CRITERIA FOR REMOVAL FROM STUDY ..................................................................... 23 14.0 BIOSTATISTICS .............................................................................................................. 24 15.0 RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES25 15.1 Research Participant Registration ................................................................................. 25 15.2 Randomization .............................................................................................................. 25 16.0 DATA MANAGEMENT ISSUES ....................................................................................... 25 16.1 Quality Assurance ......................................................................................................... 25 16.2 Data and Safety Monitoring ........................................................................................... 26 17.0 PROTECTION OF HUMAN SUBJECTS .......................................................................... 26 17.1 Privacy .......................................................................................................................... 28 17.2 Serious Adverse Event (SAE) Reporting ....................................................................... 28 17.2.1 ................................................................................................................................... 29 18.0 INFORMED CONSENT PROCEDURES .......................................................................... 29 19.0 REFERENCES ................................................................................................................. 30 20.0 APPENDICES .................................................................................................................. 33 Page 5 of 33 Memorial Sloan Kettering Cancer Center IRB #: 15-067 A(8) Approved: 19-AP R-2017 1.0 PROTOCOL SUMMARY AND/OR SCHEMA Title: Local Therapies for Oligometastatic Non-Small Cell Lung Cancer (NSCLC) harboring Sensitizing EGFR Mutations Objectives: Primary objective: To assess the safety and tolerability of local treatment of oligometastatic disease combined with tyrosine kinase inhibitor (TKI) therapy To determine the feasibility of accruing eligible patients to undergo the proposed treatment plan To collect preliminary data on the efficacy of the proposed treatment strategy: o Time to progression o Time to death o Local control at site of local therapy o Time on EGFR TKI before a new systemic therapy is required Correlative objectives: To compare the molecular alterations in the primary lung versus metastatic sites by performing next-generation