National Cancer Survivors Month

Breaking Impossible

Written by Jason Tharp

www.jasontharp.com

When you're handed a diagnosis of cancer, it feels as if the world is moving in slow motion, stuck on a continuous loop of the C-word. While life around you keeps spinning, it feels as though an elephant has climbed onto your back, requesting a lift. It's debilitating, dreadful, downright awful, and leaves a feeling of betrayal. If you're someone easily swayed by shame, you might look for ways to blame yourself. Are you a self-loathing enthusiast? Don't fret; you'll devote ample time to dissecting your mistakes. But what if none of this was your fault and it just happened?

The NRG-BN011 Study for Glioblastoma

Jason Tharp is the Patient Advocate Representative on the NRG Oncology Brain Tumor Committee, which is currently promoting the NRG-BN011 study. NRG-BN011 is a clinical study for people with a type of brain tumor called a ‘glioblastoma’ that have not yet received treatment other than surgery for their disease. Participants in this trial will need to be tested to see if their tumor has a biomarker called “methylated” MGMT. A biomarker gives information about how the tumor may respond to treatment. The MGMT methylation test helps predict if the tumor will respond to temozolomide, the standard chemotherapy drug used for glioblastomas. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. NRG-BN011 will test to see if the addition of a second chemotherapy drug called lomustine to the usual treatment of radiation and temozolomide chemotherapy can help extend your life or stabilize your cancer. Lomustine is currently approved by the Food and Drug Administration (FDA)- to treat brain tumors, however, it is usually used for recurrent tumors. Researchers are doing this study to find out if this approach is better, the same, or worse than the usual approach for your brain tumor.

Learn more about this trial at ClinicalTrials.gov

Protocol documents and materials are located on the CTSU website.

NRG-BN011 has a patient-facing study webpage available as well on the NRG website at www.nrgoncology.org/BN011.

Uterine Cancer Awareness Month

PI Perspective: The Journey of NRG-GY018

Written by NRG-GY018 Principal Investigator, Ramez Eskander, MD

Unlike other solid malignancies, there has been limited improvement in survival for women with metastatic or recurrent endometrial cancer (EC) over the last 4 decades. NRG-GY018 was designed to determine if the addition of the immune checkpoint inhibitor, pembrolizumab, to carboplatin and paclitaxel followed by pembrolizumab maintenance would result in improved survival. Based on prior trials in other solid tumors, most notably colorectal cancer, it was anticipated that a more robust improvement would be identified in the mismatch repair deficient (dMMR) EC population.

As such, the trial was designed to enroll 2 separate and independent patient populations, mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) EC. Furthermore, preclinical, and clinical data suggested that the addition of immunotherapy to chemotherapy, may help induce immunogenic cell death, priming an immune response in tumors that are historically not responsive to single agent immune checkpoint inhibition.

NRG Study News and New Protocols Under Development

SBRT to the Primary Tumor Followed by Conventional Radiation Therapy and Chemotherapy for Patients with Locally Advanced Non-Small Cell Lung Cancer (NRG-LU008)

NRG Oncology recently activated the phase III NRG-LU008 clinical trial for patients with locally advanced, inoperable, node-positive non-small cell lung cancer (NSCLC). This trial will be testing the addition of stereotactic body radiation therapy (SBRT) delivered to the primary lung tumor followed by conventional radiotherapy (RT) and concurrent platinum-based chemotherapy for this patient population.



Patients with stage II or III inoperable, node-positive NSCLC will be enrolled onto the trial and stratified by PD-L1 expression and T-stage. Trial participants will then be randomly assigned to one of two potential treatment arms. Patients on Treatment Arm 1 will receive conventional RT to all sites of known thoracic disease concurrently with chemotherapy, whereas patients on Treatment Arm 2 will receive SBRT to the primary tumor followed by conventional RT to sites of nodal metastases concurrently with chemotherapy. Both treatment arms will then receive up to 12 months of consolidation immunotherapy. The primary aims of this trial are to compare overall survival and progression-free survival between treatment arms.

NRG-LU008 Video Interview with Dr. Simone

Dr. Charles Simone discusses the NRG-LU008 study: Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

Watch the full interview

Comparing Stereotactic Radiosurgery to Hippocampal-Avoidant Whole Brain Radiotherapy for Patients with High Brain Metastasis Velocity at Distant Brain Relapse Following Stereotactic Radiosurgery (NRG-BN009)

NRG Oncology recently reactivated the phase III NRG-BN009 clinical trial following a major amendment that made changes to the study design to address insurance barriers with a goal of increasing enthusiasm among patients and physicians for engagement on this study.



NRG-BN009 will accrue patients with distant brain relapse with brain metastasis velocity of greater than or equal to four brain metastases a year since their last treatment with stereotactic radiosurgery (SRS). Trial participants will receive either the study experimental treatment of hippocampal-avoidant whole brain radiotherapy (HA-WBRT) or the standard of care treatment of SRS. Changes to the study approach did not impact the overall primary objective of the study to determine if HA-WBRT can improve freedom from neurologic death for these high-risk brain metastasis patients. 

ComboMATCH Investigators are Translating Robust Pre-Clinical Evidence for New Anti-Cancer Drug Combinations into a Series of Early-Phase Clinical Trials

Five leading cancer research organizations in the United States are jointly announcing the start of patient enrollment in Molecular Analysis for Combination Therapy Choice (ComboMATCH), a unique, precision medicine initiative to test new combinations of cancer drugs guided by tumor biology.

The Alliance for Clinical Trials in Oncology, Children's Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG Cancer Research Network plan to conduct many early-phase treatment trials through this platform in collaboration with the National Cancer Institute (NCI) National Clinical Trials Network (NCTN). NCI is part of the National Institutes of Health.

Read the joint NCTN press release 

The “SAMURAI” Study (NRG-GU012) Video Interview with

Dr. Hall 

NRG-GU012, also known as the SAMURAI study, is a phase II trial of stereotactic ablative radiation therapy (SABR) for metastatic renal cell carcinoma receiving immunotherapy. We talked with Dr. William Hall, at #NRG2023 in Orlando to discuss this study further.

Watch the full interview





New Protocols Under Development

NRG Early Career & New Investigator Fellows

NRG Oncology Awards 11 Fellows for the Early Career & New Investigator Mentored Fellowship Program

FORTE Study Update

Register for the FORTE Workshop on July 21, 2023, at the NRG Summer Meeting in Philadelphia to hear updates on this important colorectal cancer prevention clinical trial!

NRG-CC005/FORTE Coordinator: Talking Points

Have you been working on screening, enrolling, and following up with participants on behalf of the FORTE clinical trial? Did you think "It would be great if I had a tool for this purpose!" when working on a specific task? Contact the FORTE team so we can work together and develop tools for your specific needs! Fill out this survey to provide your input on how NRG Oncology can help you with FORTE at your site.

Did you miss the FORTE Site Call on May 17? Watch the recording today: https://youtu.be/xu5XOdxnym0. 

NRG NCORP Updates



NRG Oncology’s National Community Oncology Research Program (NCORP) leaders Encourage Artificial Intelligence application to Cancer Care Delivery Research (CCDR)

Drs. Julian Hong (University of California at San Francisco) and Anant Madabhushi (Emory University) Co-moderated a series of stimulating AI presentations; presenters underscored the import of equitable implementation and knowledge about algorithmic fairness to ensure AI ameliorates, not exacerbates, persisting health disparities. Drs. Hong’s and Madabhushi’ s lofty standing in the field helped secure discerning presenters Dr. Irene Chen (University of California, at Berkeley) and Wilbur Lam (Emory University). Dr. Chen challenged participants to reconsider the entire machine learning pipeline in order to advance health equity. Dr. Lam provided sage insights regarding “point of care” challenges and opportunities AI presents.

Over 100 stakeholders enrolled in April’s “AI in CCDR” webinar; This voluminous participation affirms CCDR’s reach within NCORP and beyond. Drs. Hong’s and Madabhushi’s engagement in NRG’s CCDR mission underscores the committee’s salience and national standing. Drs. Hong and Madabhushi, like presenters Chen and Lam, reside at the vanguard of technological innovation. Their expertise begets optimism for NRG’s CCDR innovation, exemplified by health equity. 

Watch the recording of the webinar here.



NRG Protocol Support Committee (PSC) Column

PSC at the NRG 2023 Summer Meeting

Written by the NRG Oncology PSC Education & Training Working Group

The NRG Oncology Summer meeting is fast approaching! The Protocol Support Committee (PSC) has been working hard to put together a variety of programing specifically for our clinical trial nurse (CTN) and clinical research associate (CRA) members. We are excited to share a sneak peek of what to expect at the 2023 NRG Oncology July Meeting in Philadelphia:

Register Today for the NRG 2023 Summer Meeting