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  MS04 - New Systemic Adjuvant/Neo-Adjuvant Strategies in Early Stage Lung Cancer: Targeted Therapy and I/O (ID 67)

  • Event: WCLC 2019
  • Type: Mini Symposium
  • Track: Treatment of Early Stage/Localized Disease
  • Presentations: 1
  • Now Available
  • Moderators:Eldsamira Mascarenhas, Jose Belda-Sanchis
  • Coordinates: 9/08/2019, 15:15 - 16:45, Hilton Head (1978)

  • 29581

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    MS04.04 - Optimal Clinical Trial Design for Adjuvant Systemic Therapy (Now Available) (ID 3458)

    15:15 - 16:45  |  Presenting Author(s): Janet Edwards
    • Abstract
    • Presentation
    • Slides

    Abstract
    

    Surgery is the gold standard local therapy for medically operable patients with stage I or II NSCLC. Adjuvant chemotherapy is indicated for high risk patients with stage IB disease as well as those with stage II disease. While cytotoxic chemotherapy remains the standard of care in the adjuvant setting, the modest benefits offered leave much room to advance therapy and improve survival in patients with early stage NSCLC (1). One particular area of enthusiasm surrounds the potential role of novel agents such as immunotherapies in the treatment of early NSCLC, given the benefits seen in the advanced NSCLC setting (2). Select ongoing studies addressing novel adjuvant therapeutic regimens in NSCLC are summarized in Table 1. This presentation examines issues surrounding advancement of knowledge in systemic therapy in the adjuvant setting. First, clinical trials must identify and address questions of relevance to both care providers and patients. These include optimal biomarker testing, the use of biomarkers as predictive and prognostic factors, the role of targeted and immunotherapies, novel and combination regimens, optimal duration of therapy and the role of maintenance therapy. Second, outcomes with clinical relevance which are also of interest to cancer patients should be prioritized such as prolongation of survival and improvement in quality of life. Third, studies should be designed in a robust manner focusing on improved efficiency and generalizability. Novel trial designs such as platform studies employing umbrella and basket protocols, driven by biomarkers with flexible objectives should be considered to accelerate clinical development and generate enthusiasm in the community of practitioners treating NSCLC. In platform studies, a single master protocol is employed in which multiple treatments are evaluated simultaneously. Platform designs can be implemented in an adaptive fashion, allowing treatments to be added as they become available, dropped for futility, or declared superior during the course of a trial (3). Inclusion and exclusion criteria, which are often quite restrictive in explanatory trial designs such as conventional randomized controlled trials, limit generalizability and are often not reflective of the real world setting. Consideration of a more pragmatic approach with broadened inclusion criteria may increase both enrollment and applicability in the broader clinical context. Other novel study designs focused on precision medicine such as co-clinical trials provide an attractive alternative to traditional early phase clinical trials. The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) trial is reviewed as an example of a biomarker driven platform study with the potential to provide actionable molecular targets, guide personalized approaches to the care of patients with early NSCLC, and establish standard of practice in those without defined genetic targets (4). Finally, in this post surgical setting, involvement of surgeons in the design and implementation of trials should be encouraged. This could serve to maximize identification and enrollment of patients. Also the integration of surgical questions with those of medical therapy will allow further advancement in the personalized care of patients. In conclusion, the ongoing challenge will be to efficiently and robustly answer questions that matter to researchers, clinicians and patients in a rapidly changing treatment landscape, keeping in mind the ultimate goals of improved survival and quality of life. References (1) Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. Pignon et al. 2008 Jul 20;26(21):3552-9. (2) Antonia et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. 2018 Dec 13;379(24):2342-2350 (3) Saville and Berry. Efficiencies of platform clinical trials: A vision of the future. Clin Trials. 2016 Jun;13(3):358-66. (4) The ALCHEMIST Lung Cancer Trials [website]. National Cancer Institute. Updated July 24, 2017. https://www.cancer.gov/types/lung/research/alchemist. Accessed July 27, 2017. 3. Cancer Research Institute [website]. Clinical trials. 2017.

    

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