1. Research Center Overview
NRG Oncology
Research Center Overview
July 2019
Mitchell Machtay, MD
University Hospitals Seidman CancerCenter /Case Comprehensive Cancer Center
Cleveland OH
NRG Deputy Group Chair for Research

2. Research Center Senior Leadership
Mitch Machtay, M.D.: Deputy Group Chair for Research
Ron Alvarez, M.D.: Chair, Research Strategy Committee
Jame Abraham, M.D.: Vice-Chair, Research Strategy Committee
Maria Werner-Wasik, M.D.: Chair, Protocol Operations Management Committee
James Dignam, Ph.D.: Group Statistician
Dr. Alvarez
Dr. Abraham
Dr. Werner-Wasik
Dr. Dignam

3. 2019 YTD in Review: Research and Highlights
NCORP Grant – Anticipated Renewal.
Multiple Developing Studies with FDA/registration intent.
ASCO 2019 Major Presentations:
NRG RTOG 9802: IDHmut as a glioma predictive factor.
NRG B39/RTOG 0413: PRO’s from WBRT vs. PBI Breast.
NRG GOG 261: Carbo/Taxol for Uterine Sarcomas.
NRG GI-002-A: Rectal TNT → Chemo-RT-Veliparib is safe.
NRG LU-001: ChemoRT +Metformin not superior.
NRG CC-001: IMRT for brain metastases PRO’s
Recognitions:
ASCO: Dr. Wolmark Gianni Bonadonna Award.
ASTRO: Dr. Curran announced as 2019 Gold Medal.

4. NRG Protocol Metrics
To Date: 54 NRG trials have been activated/open to enrollment since birth of NRG (3/1/2014): 47 CTEP; 3 Intergroup; 6 NCORP
11 study activations through July 12, 2019
Anticipate 4 more by end of year.
39 new concepts in development by NRG HQ (approved by RSC).

5. The 50th Study Activated by NRG!
LU005: SCLC: A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Chemotherapy + radiation (CRT)
Limited Stage Small Cell CA R
CRT +
Atezolizumab x 1 year
STRATIFICATION
Radiation schedule, BID (3 weeks) vs daily (6.5 weeks)
Chemotherapy (cisplatin vs carboplatin)
Gender
ECOG Performance Status (0/1 vs 2)
PIs: Kristin Higgins, MD (NRG) and Helen Ross, MD (Alliance)
Industry Collaborator: Genentech

6. Newly Activated Protocol: GU Team
GU007: Phase IIR Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (with INITIAL Phase I)
Prostate CA: high risk for recurrence determined by Gleason score
GnRH Agonist Androgen Suppression Therapy +
Dose Escalated IMRT R
GnRH Agonist Androgen Suppression Therapy +
Dose Escalated IMRT
Niraparib
STRATIFICATION
Gleason Score:
Gleason ≥ 9, PSA ≤ 150 ng/mL, any T-stage
Gleason 8, PSA < 20 ng/mL, and ≥ T2
Gleason 8, PSA ≥ ng/mL, any T-stage
Gleason 7, PSA ≥ ng/mL, any T-stage
RT: Standard fractionation vs. hypofractionation
PIs: Dror Michaelson, MD, PhD and Zachary Zumsteg, MD
Industry Collaborator: Janssen

7. Newly Activated Protocol: H&N Team
HN005: A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, p16-Positive, Non-Smoking Associated Oropharyngeal Cancer
70 Gy radiation in 6 weeks using 6 fractions per week +
Cisplatin
Oropharyngeal CA
p16-positive
≤ 10 pack-year history of smoking
8th ed. clinical stages T1-2N1M0 or T3N0-N1M0 (8th ed. stage I-II excluding T0, T1-2N0, or any N2) R
60 Gy radiation in 6 weeks using 5 fractions per week +
Cisplatin
60 Gy radiation in 5 weeks using 6 fractions per week +
Nivolumab
STRATIFICATION
Zubrod Performance Status: 0 vs.1
PI: Sue S. Yom, MD, PhD
Industry Collaborator: BMS

8. Coming Attraction Protocol: GYN Team
GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/ Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Stage II-IV low-grade serous ovarian or primary peritoneal carcinoma post 1o cytoreductive surgery
Carboplatin + paclitaxel x 6 cycles
Letrozole until disease progression R
Letrozole daily until disease progression or severe toxicity
PI: Amanda Fader, M.D.

9. Coming soon! - Anticipated Activations:
NRG-BN006: Ph II/III retroviral replicating vector in ND GBM.
NRG-GI005: Ph II/III ctDNA Predictive Marker in Stage II Colon Cancer.
NRG-GY019: Ph III 2 Arm trial Carbo/Taxol/maintenance letrozole v letrozole alone for Stage II‐IV primary low grade serous ca of ovary/peritoneum.
NRG-GY021: Ph IIR olaparib vs olaparib + tremelimumab in HRD+ and HRD‐ platinum sensitive recurrent ov ca.
NRG-GU008: Phase III Trial incorporating abiraterone/apalutamide and advanced imaging into salvage treatment for patients with node‐positive prostate cancer after radical prostatectomy
In addition: 13 ‘Study Champions’ for Other Groups’ Tirals
Themes:
Immunotherapy/ICI.
De-escalation where appropriate; escalation where appropriate.
Joint studies with other NCTN Groups.
Selected studies in metastatic cancer (not just localized).

10. Some Strategic Priorities:
Opportunities for Improvement:
OEWG Timelines to Activation
Timelines to Completion of Accrual
% success rate with NCI/Steering Committees.
Continued Emphasis on New Investigators:
Increased number and diversity of New Investigators ‘OTFS’ of protocols and on Committees and Subcommittees.
Improved coordination with NCI Biospecimen Navigator System & NRG Ancillary Projects/DataSharing
Funding for Travel & NRG-relevant pilot projects
Logistics/Operations:
Re-design of Committees/Subcommittees/Working Groups and their Membership and Leadership.
Improvements to the Meeting/Agenda.
Fundraising for NRG & coordination with the 3 Foundations.

11. Thank you and Welcome to Year 51 of NSABP/RTOG/GOG!