NCT03804580 (FIOL) is a Phase 2 clinical trial of osimertinib in Lung Cancer, sponsored by Vestre Viken Hospital Trust.

Who is sponsoring NCT03804580?

NCT03804580 is sponsored by Vestre Viken Hospital Trust.

What drugs are being tested in NCT03804580?

Interventions in NCT03804580: osimertinib.

What condition does NCT03804580 study?

NCT03804580 studies Lung Cancer.

Is NCT03804580 still recruiting?

NCT03804580 is currently active, enrolled. Last updated 7 May 2024.

Last reviewed 2024-05-07 · How we verify

NCT03804580: FIOL

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

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer

Active, enrolled Phase 2 Last updated 7 May 2024

What this trial tests

Phase 2 trial testing osimertinib in Lung Cancer in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2018

Primary endpoint
1 June 2025

31 December 2025

Quick facts

Lead sponsor	Vestre Viken Hospital Trust
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 December 2018
Primary completion	1 June 2025
Estimated completion	31 December 2025
Sites	10 locations across Denmark, Lithuania, Sweden, Norway

Drugs / interventions tested

osimertinib (osimertinib) — full drug profile →

Conditions studied

Lung Cancer — all drugs for Lung Cancer →

Sponsor

Vestre Viken Hospital Trust

Who can join

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

Sponsor's own description

Phase II, single-arm study to assess the safety and efficacy of osimertinib (80 mg, orally, once daily) as first-line therapy in patients with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously treated with an epidermal growth factor tyrosine kinase inhibitor agent.

Publications & conference data

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

Osimertinib in non-small cell lung cancer with uncommon EGFR-mutations: a post-hoc subgroup analysis with pooled data from two phase II clinical trials.
Eide IJZ, Stensgaard S, Helland Å, Ekman S, et al · · 2022 · cited 18× · PMID 35832438 · DOI 10.21037/tlcr-21-995
Near-Complete Response to Osimertinib for Advanced Non-Small-Cell Lung Cancer in a Pretreated Patient Bearing Rare Compound Exon 20 Mutation (S768I + V774M): A Case Report.
Cosi DM, Fragale C, Magri C, Carnevale A, et al · · 2024 · cited 1× · PMID 39062751 · DOI 10.3390/ijms25147508
Unarranged territory in uncommon EGFR mutations.
Fujii H, Okuma Y. · · 2022 · PMID 35958324 · DOI 10.21037/tlcr-22-478

Verify or expand the search:

Other trials of osimertinib

Trials testing the same drug.

NCT06032936 — BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations · Phase 1 · terminated
NCT05834348 — A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in N · completed
NCT05215951 — Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC · Phase 2 · terminated
NCT05153408 — (HARMONY) Study of BLU-701 in EGFR-mutant NSCLC · Phase 1 · terminated
NCT04862780 — (SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC · Phase 1 · terminated

Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

NCT07295821 — Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study · Phase 2 · recruiting
NCT06909201 — Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigatin · Phase 1 · recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07487064 — Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study · NA · recruiting
NCT07146568 — Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hos · NA · recruiting

Other Vestre Viken Hospital Trust trials

Trials by the same sponsor.

NCT07200713 — Effect Study of SMART Treatment for Youth · NA · not yet recruiting
NCT06906419 — Arthroscopic Trochleaplasty in Chronic Relapsing Patellar Dislocations: A Follow-up Study · enrolling by invitation
NCT06920654 — Stabilization of the Shoulder Joint Using a Latarjet-like Procedure. · enrolling by invitation
NCT06738381 — Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease · NA · recruiting
NCT06912061 — A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and F · NA · recruiting

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 NCT03804580 (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 Vestre Viken Hospital Trust
Last refreshed: 7 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/NCT03804580.

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