ALK positive

P3, N=1000, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

Fluorescence in situ hybridization (FISH) confirmed the presence of ALK gene breaks. A comprehensive understanding of these IMTs with leiomyoma-like features and accurate diagnosis are essential for effective patient treatment and prognosis.

Further research is needed to validate these approaches in larger cohorts. Furthermore, the favorable response to alectinib rechallenge observed in this case suggests that rechallenge therapy may offer a potential value in managing post-adjuvant recurrence, which warrants further investigation.

P3, N=68, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Dec 2026 --> Jun 2030

This case highlights that clinicians should consider drug-induced pleuritis when pleural effusion develops during brigatinib therapy, particularly when it is inconsistent with the disease progression. Dose reduction to as low as 30 mg/day may be a safe and effective therapeutic option for selected patients.

P=N/A, N=200, Not yet recruiting, Pfizer

P3, N=257, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Nov 2026 --> Nov 2031

P1, N=9, Not yet recruiting, West China Hospital

P=N/A, N=50, Not yet recruiting, Pfizer

Our study showed the constant of its heterogeneous morphology, and significance of IMTs immunophenotype, particularly in older children, where the inflammatory component is more pronounced. ALK gene alterations are commonly associated with IMT, as well as with other types of pediatric neoplasms, however, favorable outcomes in our cohort study, raise question regarding further need to clarify the prognostic significance of molecular findings and their potential therapeutic implications.

Probabilistic sensitivity analysis showed an almost 98,40% probability of cost-effectiveness at Italian willingness-to-pay thresholds. From both NHS and societal perspectives, lorlatinib represents a cost-saving and clinically superior first-line treatment option compared with alectinib for patients with ALK-positive advanced NSCLC in Italy.

We report the case of a 50-year-old woman with advanced ALK-positive NSCLC who experienced rapid tumor regression after 1 month of treatment with ensartinib, complicated by mild bilateral interstitial pneumonitis...Following progression on second-line chemotherapy, she was rechallenged with lorlatinib, which induced severe cutaneous toxicity that responded to corticosteroids...These findings highlight the need for heightened vigilance, multidisciplinary management, and the development of predictive biomarkers for TKI-associated toxicities. Future prospective studies are essential to guide safe rechallenge strategies and personalize toxicity monitoring in ALK-positive NSCLC.