DavidRSpigelMD

Oncology • Nashville, TN

Physician

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Office
250 25th Ave N
Ste 100
Nashville, TN 37203
Phone+1 615-329-0570
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Education & Training

Brigham and Women's Hospital/Massachusetts General Hospital/Dana-Farber Cancer InstituteFellowship, Hematology and Medical Oncology, 2000 - 2003
Indiana University School of MedicineResidency, Internal Medicine, 1996 - 2000
University of Tennessee Health Science Center College of MedicineClass of 1996

Certifications & Licensure

TN State Medical License 2003 - 2026
MA State Medical License 2000 - 2005
American Board of Internal Medicine Medical Oncology

Awards, Honors, & Recognition

Regional Top Doctor Castle Connolly, 2014

Clinical Trials

Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer Start of enrollment: 2004 Apr 01
Completed
Phase 1, Phase 2
Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer Start of enrollment: 2005 Jul 01
Completed
Phase 2
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer Start of enrollment: 2005 May 01
Completed
Phase 2
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer Start of enrollment: 2004 Apr 01
Completed
Phase 2
Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer Start of enrollment: 2005 Jul 01
Completed
Phase 2
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer Start of enrollment: 2006 Jan 01
Completed
Phase 2
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer Start of enrollment: 2006 Feb 01
Completed
Phase 2
Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer Start of enrollment: 2006 Feb 01
Completed
Phase 2
Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer Start of enrollment: 2006 Mar 01
Completed
Phase 2
5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer Start of enrollment: 2006 Mar 01
Completed
Phase 2
Irinotecan, Carboplatin, Bevacizumab, and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer Start of enrollment: 2006 Mar 01
Completed
Phase 2
A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel Start of enrollment: 2006 Mar 01
Terminated
Phase 1
A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer Start of enrollment: 2004 Sep 01
Completed
Phase 1, Phase 2
Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer Start of enrollment: 2006 Nov 01
Terminated
Phase 2
First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC Start of enrollment: 2007 Mar 01
Completed
Phase 2
Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC) Start of enrollment: 2008 Feb 01
Completed
Phase 2
Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib Start of enrollment: 2008 Mar 01
Completed
Phase 2
Imatinib and PTK787/ZK222584 in Refractory and/or Advanced Solid Tumors Start of enrollment: 2004 Jul 01
Completed
Phase 1
Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC Start of enrollment: 2007 Dec 01
Completed
Phase 2
Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer Start of enrollment: 2009 Feb 01
Unknown status
Phase 3
Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer Start of enrollment: 2008 Sep 01
Completed
Phase 2
PK Trial of Sorafenib & Erlotinib in Patients With Refractory Solid Tumors Start of enrollment: 2008 Oct 01
Completed
Phase 1
Trial of Poor Performance Status Patients (ToPPS) Start of enrollment: 2009 Jun 01
Completed
Phase 2
Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer Start of enrollment: 2009 Jun 01
Completed
Phase 2
A Study of NK012 in Patients With Relapsed Small Cell Lung Cancer Start of enrollment: 2009 Jul 01
Completed
Phase 2
Randomized, Double-Blind Trial of Erlotinib/Pazopanib or Erlotinib/Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer Start of enrollment: 2010 Jan 01
Completed
Phase 2
Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC Start of enrollment: 2010 Jun 01
Completed
Phase 2
A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer Start of enrollment: 2009 Dec 01
Completed
Phase 2
A Study of IMGN901 for Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer Start of enrollment: 2010 Nov 01
Terminated
Phase 1, Phase 2
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer Start of enrollment: 2011 Jan 11
Terminated
Phase 3
Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib Start of enrollment: 2014 Mar 01
Completed
Phase 2
Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer Start of enrollment: 2012 Oct 01
Completed
A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib Start of enrollment: 2012 Oct 01
Completed
Phase 1, Phase 2
Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer Start of enrollment: 2013 Sep 09
Terminated
Phase 1
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib Start of enrollment: 2013 Jun 28
Completed
Phase 3
Phase II Trial of Carboplatin and Pemetrexed +/- OGX-427 in Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer Start of enrollment: 2013 Jul 01
Completed
Phase 2
Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Start of enrollment: 2013 Aug 01
Completed
Phase 2
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy Start of enrollment: 2012 Jan 07
Terminated
Phase 1, Phase 2
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants Start of enrollment: 2013 Aug 01
Completed
Phase 2
Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer Start of enrollment: 2013 Sep 01
Completed
Phase 2
A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen Start of enrollment: 2014 Apr 09
Completed
Phase 3
A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer Start of enrollment: 2014 Mar 01
Terminated
Phase 2
Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer Start of enrollment: 2014 Mar 01
Terminated
Phase 2
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations Start of enrollment: 2014 Apr 01
Terminated
Phase 2
Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer Start of enrollment: 2014 Jun 16
Terminated
Phase 2
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer Start of enrollment: 2014 Oct 03
Active, not recruiting
Phase 3
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy Start of enrollment: 2015 Oct 05
Terminated
Phase 1, Phase 2
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Publications & Presentations

PubMed

Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomize...
Heinz-Josef Lenz, Aparna Parikh, David R Spigel, Allen L Cohn, Takayuki Yoshino, Mark Kochenderfer, Elena Elez, Spencer H Shao, Dustin Deming, Regan Holdridge, Timothy...> ;Journal for Immunotherapy of Cancer. 2024 Mar 13
A phase 2 study of AZD4635 in combination with durvalumab or oleclumab in patients with metastatic castration-resistant prostate cancer.
Gerald S Falchook, James Reeves, Sunil Gandhi, David R Spigel, Edward Arrowsmith, Daniel J George, Janet Karlix, Gayle Pouliot, Maureen M Hattersley, Eric T Gangl, Gar...> ;Cancer Immunology, Immunotherapy. 2024 Mar 2
A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer.
Erica L Mayer, Nabihah Tayob, Siyang Ren, Jennifer J Savoie, David R Spigel, Howard A Burris 3rd, Paula D Ryan, Lyndsay N Harris, Eric P Winer, Harold J Burstein> ;Breast Cancer Research and Treatment. 2024 Feb 1
4 citations
Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase II NeoCOAST Platform Trial.
Tina Cascone, Gozde Kar, Jonathan D Spicer, Rosario García-Campelo, Walter Weder, Davey B Daniel, David R Spigel, Maen Hussein, Julien Mazieres, Julio Oliveira, Edwin ...> ;Cancer Discovery. 2023 Nov 1
5 citations
A Phase Ib Study Assessing the Safety, Tolerability, and Efficacy of the First-in-Class Wee1 Inhibitor Adavosertib (AZD1775) as Monotherapy in Patients with Advanced S...
Todd M Bauer, Kathleen N Moore, Janet S Rader, Fiona Simpkins, Alain C Mita, J Thaddeus Beck, Lowell Hart, Quincy Chu, Amit Oza, Anna V Tinker, Esteban Rodrigo Imedio,...> ;Targeted Oncology. 2023 Jul 1
10 citations
Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results.
Timothy A Yap, Elisa Fontana, Elizabeth K Lee, David R Spigel, Martin Højgaard, Stephanie Lheureux, Niharika B Mettu, Benedito A Carneiro, Louise Carter, Ruth Plummer,...> ;Nature Medicine. 2023 Jun 1
2 citations
A phase Ib study of adavosertib, a selective Wee1 inhibitor, in patients with locally advanced or metastatic solid tumors.
Gerald S Falchook, Jasgit Sachdev, Esteban Rodrigo Imedio, Sanjeev Kumar, Ganesh M Mugundu, Suzanne Jenkins, Juliann Chmielecki, Suzanne Jones, David R Spigel, Melissa...> ;Investigational New Drugs. 2023 Jun 1
14 citations
First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckM...
Neal E Ready, Clarisse Audigier-Valette, Jonathan W Goldman, Enriqueta Felip, Tudor-Eliade Ciuleanu, María Rosario García Campelo, Kevin Jao, Fabrice Barlesi, Stéphani...> ;Journal for Immunotherapy of Cancer. 2023 Feb 1
8 citations
Durable responders in advanced NSCLC with elevated TMB and treated with 1L immune checkpoint inhibitor: a real-world outcomes analysis.
Richard S P Huang, David P Carbone, Gerald Li, Alexa Schrock, Ryon P Graf, Liangliang Zhang, Karthikeyan Murugesan, Jeffrey S Ross, Khaled Tolba, Jacob Sands, Geoffrey...> ;Journal for Immunotherapy of Cancer. 2023 Jan 1
26 citations
Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline, Version 2022.2.
Dwight H Owen, Navneet Singh, Nofisat Ismaila, Elizabeth Blanchard, Paul Celano, Narjust Florez, Dharamvir Jain, Natasha B Leighl, Hirva Mamdani, Gregory Masters, Pame...> ;Journal of Clinical Oncology. 2023 Feb 10
10 citations
Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2022.2.
Dwight H Owen, Navneet Singh, Nofisat Ismaila, Elizabeth Blanchard, Paul Celano, Narjust Florez, Dharamvir Jain, Natasha B Leighl, Hirva Mamdani, Gregory Masters, Pame...> ;Journal of Clinical Oncology. 2023 Feb 10
7 citations
Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: a pooled analysis.
H Borghaei, T-E Ciuleanu, J-S Lee, A Pluzanski, R Bernabe Caro, M Gutierrez, Y Ohe, M Nishio, J Goldman, N Ready, D R Spigel, S S Ramalingam, L G Paz-Ares, J F Gainor,...> ;Annals of Oncology. 2023 Feb 1
2 citations
Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, ...
Daniel J George, David R Spigel, Lucio N Gordan, Samith T Kochuparambil, Ana M Molina, Jeff Yorio, Arash Rezazadeh Kalebasty, Heidi McKean, Nishan Tchekmedyian, Scott ...> ;BMJ Open. 2022 Sep 14
40 citations
Personalized neoantigen vaccine NEO-PV-01 with chemotherapy and anti-PD-1 as first-line treatment for non-squamous non-small cell lung cancer.
Mark M Awad, Ramaswamy Govindan, Kristen N Balogh, David R Spigel, Edward B Garon, Meghan E Bushway, Asaf Poran, Joong Hyuk Sheen, Victoria Kohler, Ekaterina Esaulova,...> ;Cancer Cell. 2022 Sep 12
9 citations
Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817.
Luis G Paz-Ares, Tudor-Eliade Ciuleanu, Adam Pluzanski, Jong-Seok Lee, Justin F Gainor, Gregory A Otterson, Clarisse Audigier-Valette, Neal Ready, Michael Schenker, He...> ;Journal of Thoracic Oncology. 2023 Jan 1
38 citations
Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline.
Navneet Singh, Sarah Temin, Sherman Baker Jr, Elizabeth Blanchard, Julie R Brahmer, Paul Celano, Narjust Duma, Peter M Ellis, Ivy B Elkins, Rami Y Haddad, Paul J Heske...> ;Journal of Clinical Oncology. 2022 Oct 1
37 citations
Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline.
Navneet Singh, Sarah Temin, Sherman Baker Jr, Elizabeth Blanchard, Julie R Brahmer, Paul Celano, Narjust Duma, Peter M Ellis, Ivy B Elkins, Rami Y Haddad, Paul J Heske...> ;Journal of Clinical Oncology. 2022 Oct 1
1 citations
A real-world retrospective study of the use of Ki-67 testing and treatment patterns in patients with HR+, HER2- early breast cancer in the United States.
Jacqueline Brown, Savannah Scardo, Michael Method, Dan Schlauch, Amanda Misch, Shaita Picard, Erika Hamilton, Suzanne Jones, Howard Burris, David Spigel> ;BMC Cancer. 2022 May 6
5 citations
RESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer.
Luis Paz-Ares, David R Spigel, Yuanbin Chen, Maria Jove, Oscar Juan-Vidal, Patricia Rich, Theresa Hayes, Vanesa Gutiérrez Calderón, Reyes Bernabe Caro, Alejandro Navar...> ;Cancer. 2022 May 1
294 citations
Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
David R Spigel, Corinne Faivre-Finn, Jhanelle E Gray, David Vicente, David Planchard, Luis Paz-Ares, Johan F Vansteenkiste, Marina C Garassino, Rina Hui, Xavier Quanti...> ;Journal of Clinical Oncology. 2022 Apr 20
4 citations
Impact of Workforce Challenges and Funds Flow on Cancer Clinical Trial Development and Conduct.
Nathan A Pennell, Connie Szczepanek, David Spigel, Suresh S Ramalingam> ;American Society of Clinical Oncology Educational Book. American Society of Clinical Oncology. Annual Meeting. 2022 Apr 1
1 citations
Long-term avelumab in advanced non-small-cell lung cancer: summaries andanalyses from JAVELIN Solid Tumor.
Borys Hrinczenko, Nicholas Iannotti, Sanjay Goel, David Spigel, Howard Safran, Matthew H Taylor, Jaafar Bennouna, Deborah J Wong, Karen Kelly, Claire Verschraegen, Mar...> ;Future Oncology. 2022 Apr 1
2 citations
Discordance in Tumor Mutation Burden from Blood and Tissue Affects Association with Response to Immune Checkpoint Inhibition in Real-World Settings.
Emma G Sturgill, Amanda Misch, Carissa C Jones, Daniel Luckett, Xiaotong Fu, Dan Schlauch, Suzanne F Jones, Howard A Burris, David R Spigel, Andrew J McKenzie> ;The Oncologist. 2022 Mar 11
30 citations
Atezolizumab Treatment of Tumors with High Tumor Mutational Burden from MyPathway, a Multicenter, Open-Label, Phase IIa Multiple Basket Study.
Claire F Friedman, John D Hainsworth, Razelle Kurzrock, David R Spigel, Howard A Burris, Christopher J Sweeney, Funda Meric-Bernstam, Yong Wang, Jonathan Levy, Jessica...> ;Cancer Discovery. 2022 Mar 1
8 citations
Tumor-Specific and Tumor-Agnostic Molecular Signatures Associated With Response to Immune Checkpoint Inhibitors
Daniel Schlauch, Xiaotong Fu, Suzanne F. Jones, Howard A. Burris, David R. Spigel, James A. Reeves, Andrew J. McKenzie> ;JCO Precision Oncology. 2021 Oct 22
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Journal Articles

Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC
Roy S Herbst, Giuseppe Giaccone, David R Spigel, The New England Journal of Medicine
Differential Regulation of PD-L1 Expression by Immune and Tumor Cells in NSCLC and the Response to Treatment with Atezolizumab (Anti–PD-L1)
Alan Sandler, David S Shames, Hartmut Koeppen, Jamie Chaft, Scott N Gettinger, Alexander Spira, Daniel S Chen, Naiyer A Rizvi, David R Spigel, Proceedings of the National Academy of Sciences
Overall Survival with Durvalumab After Chemoradiotherapy in Stage III NSCLC
David R Spigel, Davey Daniel, Jhanelle E Gray, Augusto Villegas, Tarek Mekhail, Alberto Chiappori, The New England Journal of Medicine
Predictive Biomarkers for Response to EGFR-Directed Monoclonal Antibodies for Advanced Squamous Cell Lung Cancer
D R Spigel, E S Kim, S S Ramalingam, M A Socinski, C Obasaju, C J Langer, R B Natale, P D Bonomi, H Wakelee, Annals of Oncology
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Lectures

Reimbursement and Payment of Multiplex Testing in the United States
2018 ASCO Annual Meeting - Chicago, Illinois - 06/3/2018
Welcome and Introductions
2018 ASCO Annual Meeting - Chicago, Illinois - 06/2/2018

Authored Content

Evaluation of Health-Related Quality of Life and Symptoms in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer Treated with Nivolumab or Docetaxel in CheckMate 057September 2018

Press Mentions

Asher Bio Announces Dosing of First Patient in Phase 1a/1b Clinical Trial of AB248, a Cis-Targeted IL-2 Immunotherapy Product Candidate, for the Treatment of Locally Advanced or Metastatic Solid TumorsJanuary 17th, 2023
McKesson and HCA Healthcare Announce Plans to Form an Oncology Research Joint Venture to Advance Cancer Care and Increase Access to Oncology Clinical ResearchJune 23rd, 2022
Long-Term Survival Benefit in NSCLC with Another Anti-PD-1/L1 DrugFebruary 15th, 2022
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