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Background: The Worldwide Innovative Network (WIN) Consortium has developed the Simplified Interventional Mapping System (SIMS) to better define the cancer molecular milieu based on genomics/transcriptomics from tumor and analogous normal tissue biopsies. SPRING is the first trial to assess a SIMS‐based tri‐therapy regimen in advanced non‐small cell lung cancer (NSCLC). Methods: Patients with advanced NSCLC (no EGFR, ALK, or ROS1 alterations; PD‐L1 unrestricted; ≤2 prior therapy lines) received avelumab, axitinib, and palbociclib (3 + 3 dose escalation design). Results: Fifteen patients were treated (five centers, four countries): six at each of dose levels 1 (DL1) and DL2; three at DL3. The most common ≥Grade 3 adverse events were neutropenia, hypertension, and fatigue. The recommended Phase II dose (RP2D) was DL1: avelumab 10 mg/kg IV q2weeks, axitinib 3 mg po bid, and palbociclib 75 mg po daily (7 days off/21 days on). Four patients (27%) achieved a partial response (PR) (progression‐free survival [PFS]: 14, 24, 25 and 144+ weeks), including two after progression on pembrolizumab. Four patients attained stable disease (SD) that lasted ≥24 weeks: 24, 27, 29, and 64 weeks. At DL1 (RP2D), four of six patients (66%) achieved stable disease (SD) ≥6 months/PR (2 each). Responders included patients with no detectable PD‐L1 expression and low tumor mutational burden. Conclusions: Overall, eight of 15 patients (53%) achieved clinical benefit (SD ≥ 24 weeks/PR) on the avelumab, axitinib, and palbociclib combination. This triplet showed antitumor activity in NSCLC, including in tumors post‐pembrolizumab progression, and was active at the RP2D, which was well tolerated. NCT03386929 clinicaltrial.gov [ABSTRACT FROM AUTHOR]

Gaps in the translation of research findings to clinical management have been recognized for decades. They exist for the diagnosis as well as the management of cancer. The international standards for cancer diagnosis are contained within the World Health Organization (WHO) Classification of Tumours, published by the International Agency for Research on Cancer (IARC) and known worldwide as the WHO Blue Books. In addition to their relevance to individual patients, these volumes provide a valuable contribution to cancer research and surveillance, fulfilling an important role in scientific evidence synthesis and international standard setting. However, the multidimensional nature of cancer classification, the way in which the WHO Classification of Tumours is constructed, and the scientific information overload in the field pose important challenges for the translation of research findings to tumour classification and hence cancer diagnosis. To help address these challenges, we have established the International Collaboration for Cancer Classification and Research (IC3R) to provide a forum for the coordination of efforts in evidence generation, standard setting and best practice recommendations in the field of tumour classification. The first IC3R meeting, held in Lyon, France, in February 2019, gathered representatives of major institutions involved in tumour classification and related fields to identify and discuss translational challenges in data comparability, standard setting, quality management, evidence evaluation and copyright, as well as to develop a collaborative plan for addressing these challenges. What's new? The World Health Organization Classification of Tumours has been informing cancer research and clinical practice by providing an international consensus on the tumour criteria for cancer diagnosis. In a new initiative coordinated by the International Agency for Research on Cancer, major institutions are now joining forces to address the remaining challenges in translational research and facilitate the application of research results to clinical practice. The newly‐established International Collaboration for Cancer Classification and Research (IC3R) aims to provide a forum for the coordination of efforts in generating evidence, setting standards, and providing best practice recommendations for tumor classification and cancer research. [ABSTRACT FROM AUTHOR]

The National Clinical Trials Network and the National Cancer Institute‐funded cooperative groups seem to be on diverging paths. Patients with cancer would be better served by a unified national cancer clinical trials system that is responsive to their priorities and unmet medical needs. [ABSTRACT FROM AUTHOR]

BACKGROUND: Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer-review of research applications. The purpose of this study was to evaluate the role and value of patient advocates from the perspective of Cancer and Leukemia Group B (CALGB) advocates and investigators. METHODS: An online survey was sent to current and past (within 5 years) patient advocates and investigators. RESULTS. Response rates were 72.7% (16 of 22) for advocates and 56.4% (102 of 181) for investigators. Patient advocates were more likely than investigators to report the following: the clinical trial process benefited from advocate involvement on committees (100% of advocates vs 72.1% of investigators; P < .05), advocates contribute to protocol development (92.8% vs 33.8%, respectively; P < .001), the cultural appropriateness of protocols (21.4% vs 10.4%, respectively; P < .05), advocates assist with patient accrual (78.6% vs 23.4%, respectively; P < .001), and advocates add value to concept development and protocol review (100% vs 63.2%, respectively; P < .001). Over half of advocates and investigators reported gaps in patient advocate knowledge and suggested that additional clinical trials training was needed. To improve clinical trials, advocates suggested their earlier involvement in protocol development and increased support from investigators. CALGB investigators recommended improving patient advocate selection and communication skills training: CONCLUSIONS: The majority of patient advocates and investigators perceived benefits from advocate involvement in the clinical trials process; patient advocates placed more value on their role than investigators. The current results indicated that strategies to improve advocacy training and advocate-investigator communication may further enhance the role of patient advocates, and future studies that clarify the role of advocates in the prioritization and development of protocol, consent, and education materials, and on patient accrual, are warranted. Cancer 2012. © 2012 American Cancer Society. [ABSTRACT FROM AUTHOR]

The rapid pace of discoveries in tumor biology, imaging technology, and human genetics hold promise for an era of personalized oncology care. The successful development of a handful of new targeted agents has generated much hope and hype about the delivery of safer and more effective new treatments for cancer. The design and conduct of clinical trials has not yet adjusted to a new era of personalized oncology and so we are more in transition to that era than in it. With the development of treatments for breast cancer as a model, we review the approaches to clinical trials and the development of novel therapeutics in the prior era of population oncology, the current transitional era, and the future era of personalized oncology. CA Cancer J Clin 2011. © 2011 American Cancer Society. [ABSTRACT FROM AUTHOR]