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NCT06781905: DRACONIS
Description of Neurocognitive and Psychiatric Disorders Associated With Targeted Therapies Used in the Treatment of Lung Cancers With ALK/ROS1 Fusion and Their Impact on Patients' Quality of Life: Construction of an Experimental Patient-researcher Collaborative Care and Research Pathway
trial testing Assessments of neuropsychiatric, neurocognitive and psychosocial alterations in Metastatic Lung Cancer in 20 participants. Currently enrolling.
9 May 2027
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 16 January 2025 |
| Primary completion | 9 May 2027 |
| Estimated completion | 9 May 2027 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Assessments of neuropsychiatric, neurocognitive and psychosocial alterations
Conditions studied
- Metastatic Lung Cancer — all drugs for Metastatic Lung Cancer →
- Metastatic Lung Cancer With ALK/ROS1 Fusion — all drugs for Metastatic Lung Cancer With ALK/ROS1 Fusion →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Metastatic Lung Cancer or Metastatic Lung Cancer With ALK/ROS1 Fusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Targeted cancer therapies have a higher therapeutic index than chemotherapy and are prescribed to tens of thousands of patients in France each year. These treatments modify often ubiquitous signaling pathways involved in neuronal synaptic plasticity, the cellular substrate of cognitive and psychiatric functions. Neurocognitive and psychiatric disorders associated with targeted therapies are poorly described and therefore still poorly understood, although they appear to be clinically more severe than chemobrain (neurocognitive disorders related to chemotherapy). The case of patients with metastatic lung cancer with ALK/ROS1 fusion is emblematic. These cancers are treated very effectively with oral targeted therapies inhibiting the tyrosine kinase activity of ALK or ROS1 proteins (ITK-ALK/ROS1), with survival that can exceed 10 years. However, neurocognitive and psychiatric disorders associated with anti-ITK-ALK/ROS1 are reported in 7 to 60% of patients, with a prevalence of about 10% with anti-ITK-ALK/ROS1 brigatinib or alectinib and up to 53% with lorlatinib in industrial therapeutic trials. These disorders appear to be particularly frequent and severe with lorlatinib, including cognitive disorders - especially memory - mood disorders such as anxiety, depression and emotional lability, and psychotic disorders. Current therapeutic trials and care pathways are not designed to take into account these side effects related to anti-ITK-ALK/ROS1. Their incidence is therefore probably underestimated. The DRACONIS project aims to: (1) describe the complaints +/- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK/ROS1 through a rigorous neuropsychological and psychiatric evaluation (i.e. patient phenotyping) and (2) understand the experience of complaints +/- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK/ROS1 and their consequences on patients' quality of life in a comprehensive approach. The DRACONIS project is part of a multidisciplinary and collaborative approach through the establishment of a partnership between researchers, clinicians and representatives of the anti-ITK-ALK/ROS1 France Cancer du Poumon patient association. The project is notably monitored by a joint scientific committee composed of researchers, clinicians, patients and patient caregivers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06781905
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06781905 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 30 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06781905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing