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Roy S. Herbst, MD, PhD

Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology; Director, Center for Thoracic Cancers; Deputy Director, Clinical Affairs; Assistant Dean for Translational Research, Office of the Dean, School of Medicine; Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director, Translational Science

Contact Information

Roy S. Herbst, MD, PhD

Mailing Address

  • Medical Oncology

    PO Box 208028

    New Haven, CT 06520-8028

    United States

Research Summary

Dr. Herbst is committed to maintaining Yale’s status as one of the world's top centers for cancer research and patient care, through innovative programs at the cutting edge of science and clinical practice. For example, we have a facility to investigate a patient's cancer at the molecular level giving us key molecular data that our oncologists use to pursue the most promising treatments for our patients as early as possible in the course of their disease.

His work on "umbrella” trials has galvanized the field of targeted therapy and cancer drug approvals at the FDA. Nationally, he works closely with public-private partnerships to develop large master protocol clinical studies. He was co-leader for the BATTLE-1 clinical trial program, co-leads the subsequent BATTLE-2 clinical trial program. and is principal investigator (PI) of the Lung Master Protocol (Lung-MAP). These trials use molecular analysis of fresh tissue biopsies to help match patients to the best novel treatment in real time, and these results provide laboratory scientists the ability to explore and uncover potential resistance mechanisms in the clinic.

Over several decades, biomarkers have been identified that help clinicians target treatment and immunotherapies for patients with corresponding genetic mutations. Dr. Herbst has led teams that brought about the approval of several therapies (such as gefitinib, cetuximab, bevacizumab, axitinib), which have revolutionized the field and greatly enhanced patient survival. He and his Yale colleagues were among the first to describe the PD-1/PD-L1 adaptive immune response in early phase trials and to offer trials of PD-L1 inhibitors atezolizumab and pembrolizumab to lung cancer patients. His leadership in targeted therapeutics resulted in a 2020 ASCO plenary talk and publication of results of the third-generation EGFR-inhibitor osimertinib for the treatment of resected EGFR-mutant NSCLC in the New England Journal of Medicine.

Specialized Terms: Early phase clinical trials; Biomarker studies; Personalized medicine for cancer treatment. Immunotherapy for the treatment of cancer.

Coauthors

Research Interests

Lung Neoplasms; Medical Oncology; Thoracic Neoplasms; Clinical Trials, Phase I as Topic; Biomarkers, Pharmacological; Precision Medicine

Public Health Interests

Cancer

Selected Publications

Clinical Trials

ConditionsStudy Title
LungA Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)
LungPhase 2 Trial of Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous Non-Small Cell Lung Cancer
LungA Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer
LungThe Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer
LungA Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN) Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Addictive Behaviors; Mental Health & Behavioral Research; Tobacco AddictionSwitching to Potential Reduced Exposure Products in Adult Smokers (JUUL)
Diseases of the Respiratory Systems; COVID-19 Inpatient; COVID-19 OutpatientA Study Tracking Health Care Workers Exposed to COVID-19
LungPhase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
LungA Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy
Corpus Uteri; Larynx; Lung; Soft Tissue; Unknown SitesA Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
LungLUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)
LungA Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis
LungA Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)
LungDetermining Mechanisms of Sensitivity and Resistance to Anti-Cancer Therapy for Advanced Lung Cancer
LungA Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (POZITIVE20-1)
LungA Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
LungAdjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)