NCT04563871 (BLOSSOM) is a Phase 2 clinical trial of 80mg Osimertinib in Non-small Cell Lung Cancer (NSCLC), sponsored by Samsung Medical Center.

Who is sponsoring NCT04563871?

NCT04563871 is sponsored by Samsung Medical Center.

What drugs are being tested in NCT04563871?

Interventions in NCT04563871: 80mg Osimertinib.

What condition does NCT04563871 study?

NCT04563871 studies Non-small Cell Lung Cancer (NSCLC).

Is NCT04563871 still recruiting?

NCT04563871 is currently completed. Last updated 9 January 2026.

Last reviewed 2026-01-09 · How we verify

NCT04563871: BLOSSOM

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

Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)

Completed Phase 2 Last updated 9 January 2026

What this trial tests

Phase 2 trial testing 80mg Osimertinib in Non-small Cell Lung Cancer (NSCLC) in 73 participants. Completed in 25 October 2023.

Timeline

17 November 2020

Primary endpoint
25 October 2023

25 October 2023

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	17 November 2020
Primary completion	25 October 2023
Estimated completion	25 October 2023
Sites	6 locations across South Korea

Drugs / interventions tested

80mg Osimertinib — full drug profile →

Conditions studied

Non-small Cell Lung Cancer (NSCLC) — all drugs for Non-small Cell Lung Cancer (NSCLC) →

Sponsor

Samsung Medical Center

Who can join

19 and older, any sex, with Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a Phase II, open-label, single-arm, multicenter study of the efficacy and safety of osimertinib (80 mg orally once daily) in patients with LM associated with EGFRm+ NSCLC.

Publications & conference data

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

Phase II Efficacy and Safety of 80 mg Osimertinib in Patients With Leptomeningeal Metastases Associated With Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer (BLOSSOM).
Park S, Baldry R, Jung HA, Sun JM, et al · · 2024 · cited 40× · PMID 38828959 · DOI 10.1200/jco.24.00708
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
Metastatic brain tumors: from development to cutting-edge treatment.
Tanzhu G, Chen L, Ning J, Xue W, et al · · 2025 · cited 8× · PMID 39712454 · DOI 10.1002/mco2.70020

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer (NSCLC)

Currently open trials in the same condition.

NCT07361497 — A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresec · Phase 3 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT07223047 — A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agent · Phase 1, PHASE2 · recruiting
NCT07291037 — Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic N · Phase 3 · recruiting
NCT07140016 — A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) · Phase 1 · recruiting

Other Samsung Medical Center trials

Trials by the same sponsor.

NCT07482865 — Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support · NA · not yet recruiting
NCT07467213 — Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute M · Phase 4 · not yet recruiting
NCT07530913 — Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients · NA · enrolling by invitation
NCT07500701 — Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Pro · Phase 3 · recruiting
NCT07409441 — Korea Acute Myocardial Infarction Registry · not yet 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 NCT04563871 (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 Samsung Medical Center
Last refreshed: 9 January 2026

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/NCT04563871.

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