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NCT05525338: ADAPT ALEC
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
Phase 4 trial testing Alectinib in Drug Monitoring in 196 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 196 |
| Start date | 23 March 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 8 locations across France, Netherlands |
Drugs / interventions tested
- Alectinib — full drug profile →
Conditions studied
- Drug Monitoring — all drugs for Drug Monitoring →
- Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
- Lung Cancer — all drugs for Lung Cancer →
- Anaplastic Lymphoma Kinase Gene Mutation — all drugs for Anaplastic Lymphoma Kinase Gene Mutation →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Drug Monitoring or Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC). The RCT will compare the use of Therapeutic Drug Monitoring (TDM) and dose increases if alectinib 35 ng/Ml (arm A) with standard of care (arm B).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic Drug Monitoring of Kinase Inhibitors in Oncology.
van der Kleij MBA, Guchelaar NAD, Mathijssen RHJ, Versluis J, et al · · 2023 · cited 41× · PMID 37584840 · DOI 10.1007/s40262-023-01293-9 -
Cardiac Toxicity of Alectinib in Patients With ALK+ Lung Cancer: Outcomes of Cardio-Oncology Follow-Up.
Pruis MA, Veerman GDM, Hassing HC, Lanser DAC, et al · · 2023 · cited 14× · PMID 36875894 · DOI 10.1016/j.jaccao.2022.09.006 -
Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC).
Meertens M, Muntinghe-Wagenaar MB, Sikkema BJ, Lopez-Yurda M, et al · · 2023 · cited 7× · PMID 36969063 · DOI 10.3389/fonc.2023.1136221 -
Semaglutide impairs bioavailability of alectinib: a note of warning based on a cross-over pharmacokinetic drug-drug interaction study.
Heersche N, Lanser DAC, Oomen-de Hoop E, Içli A, et al · · 2025 · PMID 40308149 · DOI 10.1002/cac2.70030
Verify or expand the search:
- PubMed search for NCT05525338
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alectinib
Trials testing the same drug.
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- NCT06692491 — Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS · Phase 2 · not yet recruiting
- NCT06624059 — A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Can · Phase 1, PHASE2 · active not recruiting
- NCT06532149 — ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer · recruiting
Other recruiting trials for Drug Monitoring
Currently open trials in the same condition.
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- NCT06427317 — Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment · recruiting
- NCT03261102 — TDM Guided Early Optimization of ADAL in Crohn's Disease · NA · active not recruiting
Other University Medical Center Groningen trials
Trials by the same sponsor.
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- NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
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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 NCT05525338 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Center Groningen
- Last refreshed: 13 May 2024
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/NCT05525338.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing