NCT03858491 (OSIBOOST) is a EARLY_PHASE1 clinical trial of Cobicistat in Non Small Cell Lung Cancer, sponsored by Academisch Ziekenhuis Maastricht.

Who is sponsoring NCT03858491?

NCT03858491 is sponsored by Academisch Ziekenhuis Maastricht.

What drugs are being tested in NCT03858491?

Interventions in NCT03858491: Cobicistat.

What condition does NCT03858491 study?

NCT03858491 studies Non Small Cell Lung Cancer.

Is NCT03858491 still recruiting?

NCT03858491 is currently completed. Last updated 26 September 2022.

Last reviewed 2022-09-26 · How we verify

NCT03858491: OSIBOOST

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetic Boosting of Osimertinib

Completed EARLY_PHASE1 Last updated 26 September 2022

What this trial tests

EARLY_PHASE1 trial testing Cobicistat in Non Small Cell Lung Cancer in 11 participants. Completed in 31 December 2021.

Timeline

1 November 2020

Primary endpoint
31 October 2021

31 December 2021

Quick facts

Lead sponsor	Academisch Ziekenhuis Maastricht
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 November 2020
Primary completion	31 October 2021
Estimated completion	31 December 2021
Sites	2 locations across Netherlands

Drugs / interventions tested

Cobicistat (COBICISTAT) — full drug profile →

Conditions studied

Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Academisch Ziekenhuis Maastricht

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Osimertinib in EGFR-Mutated Lung Cancer: A Review of the Existing and Emerging Clinical Data.
Lee CS, Milone M, Seetharamu N. · · 2021 · cited 24× · PMID 34471361 · DOI 10.2147/ott.s227032
Pharmacokinetic boosting of osimertinib with cobicistat in patients with non-small cell lung cancer: The OSIBOOST trial.
van Veelen A, Gulikers J, Hendriks LEL, Dursun S, et al · · 2022 · cited 12× · PMID 35933915 · DOI 10.1016/j.lungcan.2022.07.012
Influence of germline variations in drug transporters ABCB1 and ABCG2 on intracerebral osimertinib efficacy in patients with non-small cell lung cancer.
Veerman GDM, Boosman RJ, Jebbink M, Oomen-de Hoop E, et al · · 2023 · cited 6× · PMID 37125403 · DOI 10.1016/j.eclinm.2023.101955
Systematic Evaluation of Osimertinib Population Pharmacokinetic Models in a Cohort of Dutch Adults with Non-Small Cell Lung Cancer.
Westra N, Kruithof PD, Croes S, van Geel RMJM, et al · · 2024 · cited 1× · PMID 38878145 · DOI 10.1007/s13318-024-00904-5
Osimertinib Cost Minimization in Non-Small Cell Lung Cancer (NSCLC) Treatment: Hypothesis Generation for a Population Pharmacokinetic Approach for Equivalent Dose Optimization of Osimertinib in Combination with Cobicistat.
Westra N, Kruithof PD, Croes S, van Geel RMJM, et al · · 2025 · PMID 40742292 · DOI 10.1002/jcph.70085

Verify or expand the search:

Other trials of Cobicistat

Trials testing the same drug.

NCT06385119 — A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants. · Phase 1 · completed
NCT05748093 — Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat · Phase 4 · recruiting
NCT05716854 — Electrophysiological Effects of Potential QT Prolonging Drugs · Phase 1 · completed
NCT05458102 — Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels · Phase 1 · terminated
NCT05236738 — A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tab · Phase 1 · completed

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting

Other Academisch Ziekenhuis Maastricht trials

Trials by the same sponsor.

NCT07533214 — Impact of Left-Handed Tailored Endoscopic Mitral Simulation Training on Skill Acquisition for Left-handed Surgeons · NA · enrolling by invitation
NCT06341101 — Timely Recovery After Subclinical Heart Failure · Phase 4 · unknown
NCT05654675 — Evaluation of the Use of the FUR to Quantify Tumor Glucose Consumption in Oncologic PET · recruiting
NCT04010578 — Effects of VitamIN K2 and D3 supplementaTion on PET/MRI in Carotid Artery Disease · NA · unknown
NCT05969340 — Detecting Otoconia With CT-Scan · NA · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03858491 (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 Academisch Ziekenhuis Maastricht
Last refreshed: 26 September 2022

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/NCT03858491.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing