LUNGevity Foundation’s Transforming Clinical Trials Initiative (TCTI) develops collaborative strategies to enhance innovation and patient access to safe and effective lung cancer tools and treatments as quickly as possible.
The summer slowdown did not hit TCTI. We have provided comments to FDA draft guidance documents and NCI Requests for Information, provided perspectives on recent Oncologic Drug Advisory Committee meetings, presented in a variety of forums, and planned and executed Part 1 of our Annual Regulatory Series. Thank you to all our working group members, roundtable participants, and supporters. Your support drives us forward, ensuring we can collaboratively address pressing challenges and identify actionable solutions for patients with lung cancer.
LUNGevity Regulatory Series Part 1 Recap
LUNGevity’s Annual Regulatory Series Part 1 drew over 50 participants to Washington, DC on September 22nd—including drug sponsors, U.S. FDA representatives, academic clinicians, and patient advocates—to discuss pressing challenges in clinical trial design and execution. Discussions centered around two themes:
- Alleviating Saturation and Supporting Expansion of U.S. Clinical Trial Sites
- Ensuring the Appropriate Control Arms in Randomized Controlled Trials
Actionable solutions and opportunities proposed at the meeting will influence LUNGevity working groups and focus areas into 2026.
LUNGevity Submits Comments on FDA Draft Guidance and NIH Request for Information
As part of our work to support the advancement of innovation and access to therapies and diagnostics, LUNGevity provided the following comments on draft guidance documents and requests for information relevant to the lung cancer community:
- Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects
- RFI: Inviting Comments on the NIH Artificial Intelligence (AI) Strategy
Read more about LUNGevity's policy priorities and previous comment letters on our website.
Regulatory Policy Perspectives
LUNGevity closely monitors the ever-changing regulatory policy landscape and provides timely perspectives through our new blog on the news, what it means for the lung cancer community, and how LUNGevity is addressing these issues.
- Dose-Finding and US Representativeness under the Spotlight at the ODAC’s July 2025 Meeting
- How the May 2025 Oncologic Drugs Advisory Committee (ODAC) Meeting Could Still Impact Future Lung Cancer Clinical Trials
Data Report Published on Clinical Trial Site Awareness and Experience with Participant Financial Support Programs
The Equitable Access to Clinical Trials Initiative, supported by the LUNGevity Foundation, partnered with the Association of American Cancer Institutes (AACI) to develop and perform a survey of cancer centers on their current practices, barriers, and needed resources for realizing financial support for trial participants.
Learnings from this report highlight the need for continued education and awareness across trial sites, as well as the further development of site-specific resources to guide trial site personnel in ensuring that trial participants can access financial support.
Project SignifiCanT: Discussing Appropriate Control Arms and Duration of Response Endpoints
Project SignifiCanT (Statistics in Cancer Trials), established by the FDA Oncology Center of Excellence, promotes collaboration and engagement among diverse stakeholders in designing and analyzing cancer clinical trials.
LUNGevity jointly organized two forums this past quarter.
- The April 8 Project SignifiCanT forum “Statistical Considerations for Changes in Standard of Care During Ongoing Randomized Cancer Clinical Trials” informed the discussion at Part 1 of our Annual Regulatory Series on determining the appropriate control arm.
- The September 30 forum “Statistical Considerations for Interpreting Duration of Response in Cancer Clinical Trials” aligns with ongoing LUNGevity research into the use and interpretation of duration of response as a regulatory endpoint.
Panel Participation at Society for Immunotherapy of Cancer Summit on Perioperative Clinical Trials
LUNGevity partners with the Society for Immunotherapy of Cancer (SITC), sitting on the Neoadjuvant Clinical Trial Design Working Group. Additionally, LUNGevity participated in a panel discussion at the SITC Summit on the Future of Neoadjuvant Clinical Trial Design, sharing recent work by the Foundation on perioperative clinical trial designs.
Materials from the summit can be accessed here: Neoadjuvant Virtual Summit - Society for Immunotherapy of Cancer (SITC)
If you would like to learn more about these and other ongoing TCTI initiatives at LUNGevity and get involved (including work focused on perioperative trial designs, streamlining the schedule of assessments, validation of blood-based lung cancer screening tests, and more) please email [email protected].
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