Metastatic #lungcancer — effective targeted therapy for 10 years and counting!

Lung cancer research gives patients hope, time with loved ones, and better quality of life. Ten years ago today, I entered a targeted therapy clinical trial for my ROS1+ lung cancer, taking an oral drug called crizotinib (trade name Xalkori). I’m still taking it (it’s now approved by the FDA and in many other countries) and have had no evidence of disease since I started it. Pretty amazing, since I had been given an expiration date of 2 years at the outside for my metastatic non-small cell lung cancer.

In honor of Lung Cancer Awareness Month, please donate to lung cancer research. The ROS1ders will be offering research grants next year! Any amount will help.


Eleven Years and Counting …

Today marks 11 years since I was first diagnosed with advanced lung cancer.

Eleven years with the mostly deadly cancer. Imagine that!

When I was diagnosed, my life expectancy was 2 years on the outside, and that was higher than the average because I was relatively young and otherwise healthy. The majority of lung cancer patients died within a year of diagnosis.

Thanks to online patient communities, targeted therapies, biomarker testing, clinical trials, and dedicated clinicians like Dr. Ross Camidge, whose smiling face appears next to mine in this picture, I’m still here. These things, along with additional new treatments like immunotherapy, new biomarkers, lung cancer screening, and ongoing medical research are changing the face of lung cancer. The expected survival of advanced lung cancer patients has risen by several YEARS since I was diagnosed.

Today, I’m grateful. Grateful for the medical research and treatments that have kept me alive with a good quality of life. Grateful for the additional time I’ve had with my family and this amazing universe. Grateful for finding a new purpose as a lung cancer research advocate collaborating on The ROS1ders, IASLC Supportive Training for Advocates on Research and Science (STARS), and other projects. And especially, I’m grateful for the wonderful friends and colleagues I’ve met along the way.

My prayer is that someday ALL people will have ready access to effective treatments and compassionate care for their health conditions, no matter what they look like, where they live, how much money they have, or how others believe they should be treated.

FDA Listening Session on Molecular Subsets of NSCLC — 21-Jan-2021

The US FDA is hosting a listening session to gather patient perspectives on oncogene-driven lung cancer. Representatives from several biomarker patient groups will speak; I will be speaking on behalf of The ROS1ders. Representatives from the FDA will share ways they are addressing the concerns raised by the patients.

When: Thursday, January 21, 2:30 pm to 4 pm ET.

Where: To receive a link to the event, register free at

If you’re unable to attend, you can watch the recording later.

March 30, 2020 Update to the Joint Statement on #Coronavirus #COVID19 From #LungCancer Advocacy Groups

The post below is shared with permission. It can also be found on the websites of the lung cancer advocacy organizations listed at the end of this blog post.


As of March 30, 2020, cases of the virus surge in countries around the world. The United States now has the highest number of COVID-19 cases globally. The CDC has issued a travel advisory for the New York tri-state area, which has the highest number of cases in the country.

In this week’s update, we discuss lung cancer treatment and clinical trials in the era of COVID-19. The information presented in this update, though current, is a work-in-progress built on very little data. Implementation across institutions and trial sites will vary based on availability of resources and healthcare workers.

Also, please don’t forget to check out the Resources list.

Lung cancer treatment and COVID-19

The oncology community is currently balancing treatment decisions for lung cancer patients, in light of the COVID-19 pandemic. Two factors are being used to decide what’s best for our patients:

  • Whether a delay in cancer diagnostic tests or treatment presents more risk than potential COVID-19 exposure in the clinic
  • Whether a difference in treatment approach can help reduce clinic visits and interactions with others

The CDC continues to recommend social distancing to help decrease transmission of COVID-19 within the community. Social distancing measures, such as cancelling public gatherings and avoiding crowds, can slow the spread of the virus and spread cases out over a longer period of time, which can help hospitals provide care while avoiding being overwhelmed by patients. Social distancing helps “flatten the curve” in the spread of an infectious disease. This is especially critical because hospitals and health systems are working at full capacity. Flattening the curve ensures that systems are functional and people who require care the most can get the attention they need. The CDC recommends a distance of 6 feet or 2 meters as the minimum distance between individuals as part of COVID-19 mitigation strategy.

Currently, lung cancer patients may need to engage with the oncology care system for the following reasons:

  • clinic visits
  • tissue and liquid biopsies
  • surgical procedures
  • infusion sessions for chemotherapy or immunotherapy (or both)
  • refill targeted therapy drugs
  • radiation treatments
  • hospital admissions
  • blood draws for laboratory tests, and
  • imaging tests to check if treatments are working

Also, family members may sometimes accompany patients when they are visiting their doctors.

Recent studies out of China suggest that hospital admissions and repeated clinic visits increase the risk of COVID-19 exposure for patients. Further, a JAMA Oncology study reported that the infection risk for cancer patients in a tertiary care institution was 2-fold higher than the cumulative incidence observed in the city of Wuhan over the same time period. In light of these data and the rapidly evolving COVID-19 pandemic, the oncology community has come up with the following suggestions for cancer treatment. Please be advised that these recommendations are subject to change.

Small Cell Lung Cancer (SCLC):

If you have a confirmed diagnosis, you may not wish to delay treatment (such as chemotherapy and radiation). You and your doctor should discuss what’s right for you.

Early stage non-small cell lung cancer (NSCLC) (Stage I to IIIB):

  • If you have already had surgery, your doctor may decide to not start with adjuvant chemotherapy and/or radiation.
  • If you have not yet had surgery, you and your doctor may decide to wait on the surgery or your doctor may suggest stereotactic body radiation therapy (SBRT).
  • If you are currently having chemo-radiation, your doctor may decide to continue with your treatment or wait on additional treatment.

Advanced stage non-small cell lung cancer (NSCLC) (Stage IIIC-IV):

  • If you are on a targeted therapy (pill), you may continue with your treatment as planned. Make sure to check with your doctor and pharmacist to ensure an adequate supply of your cancer medication.
  • If you are already on immunotherapy or chemotherapy, your doctor may decide to continue with your treatment, space out infusions, or postpone treatment. They may decide to have you receive infusions at your local clinic or even home infusion, as needed.
  • If you are already undergoing radiation therapy, your doctor may choose to hold off on additional treatment, reduce the number of treatments, or keep you on treatment as planned, based on your individual health situation. 

Several recent forums have discussed the management of lung cancer during the COVID-19 pandemic. Topics that are currently being addressed by lung cancer providers/thought leaders include:

  • How to determine whether pneumonitis is resulting from checkpoint inhibitor or COVID-19 infection
  • Should immunotherapy be withheld from patients whose tumors do not have known driver mutations (as determined by molecular testing)?
  • Spacing out or postponing infusions for patients on pemetrexed or immunotherapy maintenance
  • Reducing the number of fractions used in radiation therapy
  • Uncertainty regarding how COVID-19 treatments in clinical trials (such as remdesivir and hydroxychloroquine) may interact with immunotherapy drugs and tyrosine kinase inhibitors
  • The growing role for liquid biopsies in places where surgical biopsies are not currently practical (use of mobile phlebotomy too)
  • Challenges of spacing out chemotherapy schedules in light of current reimbursement
  • Growing role for telemedicine (effective for managing patients but loss of doctor-patient bond)
  • Educating others on their care teams to overcome lung cancer nihilism and stigma

All treatment decisions should be made jointly by you and your doctor. Do not change your treatment plan or doctor’s visit without consulting your doctor first.

Telehealth or remote consults may be an option for checking in with your doctor. Also, there may be the option to be referred to a “COVID-19-free” hospital or treatment center.

Clinical trials and COVID-19

Clinical trials continue to be a source of life-saving therapies for lung cancer patients. The COVID-19 pandemic has affected the conduct of clinical trials due to the following reasons:

  • Questions related to safety of patients traveling to trial sites and undergoing trial-related procedures
  • Potential shortage of healthcare providers to conduct trial-related activities
  • Interruptions to the supply chain of the drug(s) being tested

The US Food and Drug Administration has recently issued guidance to help clinical trial sponsors figure out the best approaches to ensure that trials can proceed within resource-constrained settings. A clinical trial sponsor in this case is defined as any entity (for example, a pharmaceutical company) involved in the development and testing of drugs and other interventions in clinical trials. Below we have summarized key points from the FDA guidance that are important from the patient perspective.

For clinical trials that are already ongoing:

  • Sponsors should consider each circumstance, assess the potential impact on the safety of trial, and modify study conduct accordingly. Decisions regarding this could include continuing trial recruitment, continuing use of the new drug(s) for patients already involved in the trial, and the need to change patient monitoring schedules throughout the trial. Clinical trial participants should be kept updated on any changes that a sponsor decides to implement.
  • Sponsors, doctors involved in the trials, and Institutional Review Boards (IRBs) may decide that the protection of a patient’s safety, welfare, and rights would be best served by continuing or by discontinuing use of the investigational product or participation in the trial. However, such decisions will depend on the specific circumstances of the clinical trial and the patients enrolled.
  • Given that trial participants may be unable to come to investigational sites due to protocol-specified visits, sponsors should assess whether alternative methods for safety evaluations could be implemented when necessary and feasible. Additionally, in deciding to continue or discontinue use or administration of the new drug(s), sponsors should consider whether the safety of participants can be ensured by implementing the alternative approach of monitoring such as local scans and blood tests. Sometimes, patients may require additional safety monitoring.

Several sponsors already have different measures in place to allow conduct of clinical trials and avoid as much disruption as possible, such as:

  • Allowing patients to have blood draws and CT scans at local cancer centers and clinics
  • Shipping drug supplies to patients, especially for targeted therapy (pills) trials
  • Remote consent
  • Mobile phlebotomy

If you are part of a clinical trial, we recommend you discuss your trial participation immediately with your research team.  If you were considering enrolling in a clinical trial, you may want to discuss with your treating physician what options are available for you. Any decision about trial participation should be made jointly by you and your healthcare team.

Resources and websites:

  1. IASLC’s Guide to COVID-19 and Lung Cancer –
  2. The National Cancer Institute has a special website for COVID-19 and emergency preparedness. Coronavirus: What People with Cancer Should Know –
  3. We are following updates provided by the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC), which can be found here:
  1. The American Medical Association is also maintaining a resource website for healthcare providers. You can find more information here:
  1. If you cannot avoid air travel, check out this handy article on “Dirtiest Places on Airplanes: How to Avoid Germs

GO2 Foundation for Lung Cancer
(Amy Moore, PhD )
LUNGevity Foundation (Upal Basu Roy, PhD, MPH )
Lung Cancer Foundation of America (Kim Norris )
Lung Cancer Research Foundation (Jan Baranski, PhD
LungCAN (Kimberly Lester

Help guide efforts to modernize — submit comments by 14-March-2020

ALL HANDS ON DECK! Engaged patients, patient advocates, research advocates:  this means YOU. (the federal website that lists all available clinical trials) is being modernized, and they want to hear from YOU. Please submit your comments and suggestions about the clinical trials submission process, site functionality, data standards, ease of searching, etc by 14-Mar-2020 at

A public meeting will be held April 30 to discuss the submissions.

What is an IRB and why should patients care?

Image credit:  This Photo by Unknown Author is licensed under CC BY-ND

Swimming in federal alphabet soup (SACHRP version)

I’m pleased to share that I’m now officially a federal employee–I’m a newly minted member of HHS OHRP SACHRP.

Say what? Let’s spell out the acronyms.

HHS = US Department of Health and Human Services (HHS) is an agency of the Executive Branch of the US Government. The Secretary of HHS is a member of the President’s Cabinet. The HHS mission is “to enhance and protect the health and well-being of all Americans.”

OHRP = Office for Human Research Protections (OHRP) is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS. OHRP “provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).”

SACHRP = Secretary’s Advisory Committee on Human Research Protections (SACHRP) “provides expert advice and recommendations to the Secretary of HHS on issues pertaining to the protection of human subjects in research.”

So why does this matter?

I’ll know more about my role after I attend my first meeting in Washington DC at the end of July. I hope to provide a patient perspective on (and hopefully help influence) the conduct and ethics of cancer research and clinical trials. Three potential areas of clinical trials I’d like to see clarified are (1) reimbursement of patient expenses for cancer trial participation, (2) the use of social media during a clinical trial, such as communication between patients in the same trial, and (3) reasonable guidelines to increase patient access to test results generated by their samples and data sharing between research projects.

Below is the official announcement posted this morning on the OHRP listserv. I am one of seven new SACHRP members just appointed to a three-year term. I’m in a pretty accomplished group!


OHRP wishes to express our sincere appreciation to all nominees who requested consideration for membership on the Secretary’s Advisory Committee on Human Research Protection (SACHRP).

We are pleased to announce the appointment of the following new members:

  1. Mary Ellen Allen, J.D.

Mary Ellen Allen is Assistant General Counsel, Specialist, Healthcare Law Group, at Genentech, Inc. She has extensive experience and expertise in human subject protections and clinical research, including FDA regulations and guidelines, privacy, GCP, compliance, diagnostics and innovation. As Associate General Counsel, Specialist at Genentech she supports the company’s global clinical development programs and provides legal support regarding General Data Protection Regulation (GDPR) Readiness and implementation, data sharing, and personalized healthcare matters. She is Legal Lead for Roche’s Human Genetics initiatives, including Individual Return of Genomic Results to Study Participants program, and supports the Roche Bioethics organization, including pre-approval and post-trial access to investigational drugs, and am a member of Roche Bioethics Network, Roche Scientific and Ethics Advisory Group Operating Committee, and Roche global Pharma Biorepository Governance Committee.

  1. Jyoti Angal, D.S., MPH

Dr. Angal is the Director of the Regulatory Knowledge Core within the Collaborative Research Center for American Indian Health, funded by NIMHD that provides a platform to bring together tribal communities and health researchers from multiple disciplines to work together in the development of cutting-edge transdisciplinary research that will address the significant health disparities experienced by American Indians in South Dakota, North Dakota and Minnesota. In her role, she provides leadership to tribal partners to establish independent, systematic research review processes, including setting up a tribal research review board. Her interests include building capacity for ensuring the highest standards for human subjects protections. In addition to her position, she provides regulatory oversight for several NIH funded longitudinal research studies. Dr. Angal is also the Director of Clinical Research at Avera Research Institute Center for Pediatric & Community Research, Avera McKennan Hospital and University Health Center, Sioux Falls, SD.

  1. Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I

As the Director of the Yale University Human Research Protection Program, Ms. Coleman serves as the Human Research Protection Administrator for the University and is responsible for the oversight and administration of Yale’s comprehensive Human Research Protection Program, which includes providing administrative and regulatory support for the Yale IRBs, RDRC, and RIDC. In her role, she is responsible for a number of functional duties including, serving as the lead for inquiries regarding audits and inquiries from regulatory agencies and accreditation bodies; assessing HRPP policies and practices for operational efficiency and compliance with applicable laws, guidelines, accreditation standards, and local context requirements; and collaborating with University stakeholders on operational initiatives related to research. Ms. Coleman also serves on several Yale University committees including the Institutional Conflict of Interest Committee, Investigator Conflict of Interest Committee, Institutional Biosafety Committee, Institutional Research Compliance Committee, Data Safety Monitoring Committee, and other committees focused on research policy matters.

  1. Janet Freeman-Daily, MSc, ENG

Janet Freeman-Daily is a stage IV Lung Cancer Survivor and Patient Advocate. In her previous career, Janet was an aerospace systems engineer where, among other things, she learned to be a technical translator.  She now brings that same experience and science to lung cancer via writing, blogging, public speaking, as well as collaborating with other patients, care partners, advocates, healthcare providers and researchers.  Janet is active on social media with her own blogspot, Gray Connections, and is a moderator of #LCSM Chat, promoting ePatient self-advocacy.  When asked what her goal is, Janet says, “I intend to keep advocating for lung cancer patients until I’m out of treatment options and energy.” She is co-founder, The ROS1ders at (05/2015-present) and Global ROS1 Initiative, and co-developer and Project Director, Hope with Answers video conversations, in collaboration with Lung Cancer Foundation of America (LCFA) and International Association for the Study of Lung Cancer (IASLC).

  1. Robert “Skip” Nelson, M.D., M.Div. Ph.D.

Dr. Nelson is currently Senior Director, Pediatric Drug Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Before joining Johnson & Johnson in January 2018, Dr. Nelson was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration, providing consultation throughout FDA on clinical and ethical issues arising in the development of FDA-regulated products for children, and serving as a standing member of the internal FDA Pediatric Review Committee. Dr. Nelson was a member and then Chair of the FDA Pediatric Advisory Committee prior to joining FDA in 2006.

  1. Walter L. Straus, M.D., MPH, FACP, FCPP

Dr. Walter Straus is Associate Vice-President and Therapeutic Area Head for Infectious Disease Therapeutics and Vaccines in Global Clinical Safety and Pharmacovigilance at Merck and Co., Inc. In this capacity his team serves as the company’s patient safety steward, and is responsible for overseeing aggregate clinical safety assessment of late stage products in development as well as post-licensure safety monitoring and assessment for all Merck vaccines and infectious disease therapeutics.  During his tenure at Merck, he has been a co-author on corporate policies pertaining to human research protection and corporate responsibility. He is a member of the Board of Directors of Public Responsibility in Medicine and Research, a member of the Executive Committee of the Harvard Multi-Regional Clinical Trials Network, and a Fellow of the American College of Physicians and of the College of Physicians of Philadelphia.

  1. Consuelo H. Wilkins, MD, MSCI

Consuelo H. Wilkins, MD, MSCI, is the Executive Director of the Meharry-Vanderbilt Alliance and Associate Professor of Medicine at both Vanderbilt University Medical Center and Meharry Medical College. Dr. Wilkins is a clinical investigator and engagement researcher who is an Associate Director of the Vanderbilt Institute for Clinical and Translational Science, where she oversees programs in community engagement and team science. Dr. Wilkins is currently a Principal Investigator of the Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health, which focuses on decreasing disparities among African Americans and Latinos using precision medicine; and the Vanderbilt Recruitment Innovation Center, a national center dedicated to enhancing recruitment and retention in clinical trials. She is widely recognized for her innovative work developing and testing methods and tools to engage patients and communities in research and was recently named director of the Engagement Core of the All of Us Research Program, a national precision medicine project which will enroll a million or more participants.

8 years in the Cancerverse

ROS1der cofounders Lisa Goldman, Janet Freeman-Daily and Tori Tomalia at the C2 Awards Ceremony in New York City May 2, 2019.

Eight years ago today, I first heard the words, “You have lung cancer.”

In 2011, I was diagnosed with stage IIIa non-small cell lung cancer (NSCLC). I had traditional chemo and radiation. Once treatment ended, my cancer immediately spread to a new site. Then I learned about online patient communities, and biomarker testing for genomic alterations, and clinical trials. I had more chemo and radiation. My cancer spread again. Then I tested positive for ROS1+ NSCLC, and entered a clinical trial. Now my  cancer has been undetectable by scans for over 6.5 years thanks to research.

Eight years ago today, I first heard the words, “You have lung cancer.”

In 2011, the majority of lung cancer patients were diagnosed after the cancer had already spread, and half the patients died within a year of diagnosis. Now we have lung cancer screening for those at high-risk of lung cancer, to catch the disease in early stages when it is curable. We have new therapies that are allowing some patients to live well for 4 years or more. In 2011, the standard of care guidelines published by the National Comprehensive Cancer Network for non-small cell lung cancer were updated about once every 5 years.  Now the guidelines are updated about 5 times a year to keep pace with the record number of new treatment approvals that are proving effective for an every-increasing number of patients.

Eight years ago today, I first heard the words, “You have lung cancer.”

In 2011, I had no idea what cancer advocates did. I’d never met any. As I began to feel better, I wondered why I was still alive when so many others had died. Gradually I began supporting others in online forums, telling my lung cancer story, learning about treatment options and research, and sharing my patient perspective with the lung cancer community, medical professionals, and policy makers in hopes of increasing funding, acclerating research, and improving outcomes for other lung cancer patients. Now there are dozens of other lung cancer patients and caregivers advocating as well.

Eight years ago today, I first heard the words, “You have lung cancer.”

From that singular moment of disbelief and panic, I started on a journey that has changed my priorities, and my approach to life in general.  I now focus on living life to the best of my ability (whatever my abilities might be at the moment), on what matters most to those I love, on what will make a difference for other lung cancer patients–especially those who have my rare type of cancer.

I wonder what the next 8 years will bring.


Join me for @TheALCF Lung Cancer Living Room 1/15 5:30 PM Pacific

Please join lung cancer patients/survivors Teri Kennedy, Jeff Julian, Don Stranathan, Andy Trahan, and me, along with Dr. Amy Moore (Director of Science and Research, Bonnie J. Addario Lung Cancer Foundation, also know as ALCF) Tuesday January 15, 2019 5:30-7:30 pm Pacific Time for a discussion on “Navigating the Latest Advances in Lung Cancer Treatment.” I’ll have an opportunity to talk about The ROS1ders and the research project we created  in partnership with ALCF.

Join us in person in San Carlos, California, watch live on Facebook, or watch later on YouTube or in the Living Room Library.