Clinical Trials

Given the patient's osseous disease, the panel discusses bone-directed therapy integration.

All panelists select lorlatinib at 600 mg for this patient based on response rates, duration of disease control, favorable tolerability, and its design intent to achieve superior CNS penetration compared to earlier-generation ROS1 inhibitors, which is particularly relevant given the patient's age, symptomatic disease burden, and risk of future CNS progression.

The first clinical case presents a 58-year-old female never-smoker with persistent cough, mild dyspnea, and new right-sided pleural effusion.

The panel addresses scenarios where patients arrive on treatments other than the panel's preferred agent.

Beyond efficacy, the panel identifies the key factors influencing agent selection: brain metastasis activity given the high prevalence of CNS involvement in younger ROS1-positive patients; toxicity profiles (earlier agents cause significant dizziness, taste changes, and neuropathic pain that are poorly tolerated chronically); frequency of clinic visits; and insurance access.

Real-world claims data show alectinib beats crizotinib in ALK+ NSCLC survival, urging early use of newer ALK inhibitors.

Merck and Gilead discontinue KEYNOTE-D46/EVOKE-03 after combination fails to demonstrate statistically significant progression-free survival benefit over pembrolizumab monotherapy

The panel discusses first-line treatment selection once a ROS1 fusion is confirmed in a treatment-naive patient.

The panel discusses how patients with ROS1-positive advanced NSCLC arrive in clinic through in-system diagnosis, second opinions, or new patient referrals and the detective work required to ensure complete molecular testing is available before treatment decisions.

ROS1 gene fusions occur in approximately 1% to 2% of advanced NSCLC cases, a small but clinically meaningful subset predominantly found in younger patients, women, light or never smokers, and those with non-squamous histology, most commonly adenocarcinoma.

With 4 ROS1-directed TKIs now in the mix, community oncologists need a clear framework for sequencing and CNS considerations in this rare NSCLC subset.

Gedatolisib moves frontline in HR+/HER2– metastatic breast cancer, adding endocrine-sensitive patients and testing triplets vs ribociclib to boost PFS.

Dr Danny Nguyen discusses the shift of clinical trials to community settings, the impact of AI in oncology, and the latest drug approvals in lung cancer care.

Cancer breakthroughs surge, but trials and novel therapies stay out of reach for many. See how community care, policy, and design can close gaps.

Global phase 3 trial tests safusidenib maintenance after chemoradiotherapy, aiming to delay recurrence and improve survival in IDH1-mutant astrocytoma.

Panelists discuss how emerging targeted agents are poised to reshape the therapeutic landscape for EGFR-mutant NSCLC in the coming years.

Panelists discuss how proactive sequencing strategies optimize long-term outcomes in EGFR-mutant non–small-cell lung cancer (NSCLC) by anticipating resistance patterns.

Panelists discuss how patient-centered counseling and shared decision-making shape personalized treatment journeys in EGFR-mutant non–small-cell lung cancer (NSCLC).

Panelists discuss how adherence to guidelines and vigilant imaging support optimal management of CNS disease in EGFR-mutant non–small-cell lung cancer.

Panelists discuss how real-world practice blends evidence-based guidance with individualized adjustments for high-risk EGFR-mutant non–small-cell lung cancer (NSCLC) cases.

Panelists discuss how trial data and practical considerations inform the nuanced choice between amivantamab–lazertinib and osimertinib in managing EGFR-mutant non–small-cell lung cancer (NSCLC) with CNS disease.

Panelists discuss how personalized molecular insights drive first-line therapy choices in EGFR-mutant NSCLC with complex metastatic profiles.

FDA's new guidance clarifies overall survival data collection in clinical trials, emphasizing long-term follow-up, subgroup analysis, and trial design considerations.

Dr Harpreet Singh explores the FDA's new guidance on overall survival as a clinical trial endpoint, addressing its implications and challenges in oncology.

A groundbreaking trial for TYRA-300, an oral FGFR3 inhibitor, aims to transform treatment for patients with low-grade intermediate-risk bladder cancer.

Travel barriers and lack of local sites hinder clinical trial enrollment for underserved patients, and decentralizing trials is key to improving access, according to Mariam Eskander, MD, MPH.

A groundbreaking telehealth trial offers remote access to innovative pancreatic cancer treatment, enhancing patient participation and care coordination nationwide.

The pivotal AMPLIFY trial aims to support FDA approval of ⁶⁴Cu-SAR-bisPSMA as a best-in-class imaging tool in prostate cancer.

Cohort 1 of the GTB-3650 phase 1 trial completed with no safety issues observed in patients with CD33-expressing hematologic malignancies.