Observational studyThe oncologist2025
ENIGMA+: a national, decentralized, remote consent study for clinical data and biospecimen collection in patients with ALK-positive advanced NSCLC.
Observational study in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04881916 (Elucidating Novel Immune and Genomic Markers for ALK), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Elucidating Novel Immune and Genomic Markers for ALK (ENIGMA+)
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
objectiveDespite advances in ALK inhibitors for ALK fusion-positive (ALK+) non-small-cell lung cancer (NSCLC), drug resistance remains a challenge. Studies of treatment outcomes and resistance biomarkers are imperative for drug development, yet patient representation can be limited. This study evaluated the feasibility of a decentralized research infrastructure to establish a clinical and biospecimen repository, broadening patient access and inclusion. PATIENTS AND
methodsPatients with advanced ALK+ NSCLC across the United States were enrolled through remote informed consent. Clinical history and tumor molecular profiling data were collected at baseline and during remote follow-ups. Archival tumor and saliva biospecimens (for germline sampling) were obtained for analysis.
resultsOf 87 eligible patients, 80 (92%) completed remote consent and enrolled. The clinical data collection rate was 100%, with archival tumor acquired from 80% and saliva samples from 65%. Patients represented 31 states, with 94% residing outside the study center's state and 90% receiving care elsewhere. Next-generation sequencing was conducted on 55 treatment-naïve and 18 treatment-resistant biopsies, all of whom received at least one prior second-generation ALK inhibitor, and 9 received lorlatinib. ALK resistance mutations were identified in 54% of treatment-resistant biopsies; other commonly co-altered genes included TP53 (18%) and CDKN2A/B (16%).
conclusionsThis study highlights the feasibility of a decentralized design to enhance the inclusion of a broader patient population with ALK+ NSCLC. This establishes a scalable framework that may help overcome barriers to patient participation in research, with the goal of improving therapy development and patient outcomes. The Elucidating Novel Immune and Genomic Markers for ALK+ study accrual and analysis continue (NCT04881916).
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