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

NCT04563871 | Completed Phase 2

• 1 other identifier: 2020-09-013
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Overall survival

  To investigate the efficacy of osimertinib on LM as measured by OS

  Up to 30 months

Secondary Outcomes (5)

• LM ORR(Objective response rate)

  Up to 30 months

• LM DoR(Duration of response)

  Up to 30 months

• LM DCR(Disease control rate)

  Up to 30 months

• LM PFS(Progression-free survival)

  Up to 30 months

• CSF response rate based on CSF cytology

  Up to 30 months

Study Arms (1)

80mg Osimertinib

EXPERIMENTAL

One tablet of 80mg Osimertinib for oral administration per day

Drug: 80mg Osimertinib

Interventions

80mg Osimertinib DRUG

One tablet of 80mg Osimertinib for oral administration per day

Also known as: Tagrisso 80mg

80mg Osimertinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
• Male and female patients must be at least 18 years of age.
• Patients must have documented (only allowed for EGFRm+ \[exon 19 deletions or L858R\] in pre-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below:
• \- EGFR TKI pre-treated patients: EGFRm+ (exon 19 deletions or L858R), along with valid T790M mutation status
• All patients will be required to have NSCLC associated with at least 1 site of LM as identified by the Investigator that can be assessed by MRI scan and that is suitable for repeat assessments. Measurable INC or EXC disease by RECIST 1.1 is not required. Concomitant brain metastases and brain metastases previously treated with radiation therapy are allowed. In addition, asymptomatic untreated BM is also allowed.
• EGFR TKI pre-treated patients must have had at least 1 prior EGFR TKI (eg, gefitinib, erlotinib, icotinib, dacomitinib or afatinib) and may have had other lines of therapy
• If the patients is T790M negative, EXC must be stable following previous EGFR TKI treatment. EXC progression is allowed if patients are T790M positive patients
• ECOG/WHO performance status 0 to 2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• Females must be using highly effective contraceptive measures and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
• Post-menopausal, defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
• Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation Further information is in Appendix I (Definition of women of childbearing potential and acceptable contraceptive methods).
• Male patients must be willing to use barrier contraception
• If a patient declines to participate in any voluntary exploratory research of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.

You may not qualify if:

• EGFR TKI pre-treated patients whose T790M mutation status cannot be determined.
• EGFR TKI pre-treated patients with progressing EXC disease who are T790M mutation-negative. Progressing EXC disease is defined as RECIST 1.1 PD no more than 3 months prior to enrollment, per Investigator assessment.
• Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
• Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.
• Any of the following cardiac criteria:
• Mean resting corrected QTc \>470 msec, obtained from ECGs, using the screening clinic ECG machine-derived QTc value
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block, and second degree heart block)
• Patients with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as the following electrolyte abnormalities, heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP):
• Hypokalemia (serum potassium \<3.5 mmol/L)
• Hypomagnesemia (serum magnesium \<0.7 mmol/L)
• Hypocalcemia (corrected serum calcium \<2.1 mmol/L)
• Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
• Absolute neutrophil count \<1.5×109/L
• Platelet count \<100×109/L
• Hemoglobin \<90 g/L

Sponsors & Collaborators

• Samsung Medical Center: lead
• AstraZeneca: collaborator

Study Sites (6)

ChungBuk National University Hospital

Cheonju, South Korea

Location

National Cancer Center

Goyang, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Park S, Baldry R, Jung HA, Sun JM, Lee SH, Ahn JS, Kim YJ, Lee Y, Kim DW, Kim SW, Lee KH, Lee WJ, Choi JW, Chong K, Lee JI, Gwon SH, Son NH, Ahn MJ. 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). J Clin Oncol. 2024 Aug 10;42(23):2747-2756. doi: 10.1200/JCO.24.00708. Epub 2024 Jun 3.

  PMID: 38828959 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Se-Hoon Lee, M.D, Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Model Details: 80 mg Osimertinib

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 25, 2020
• Study Start: November 17, 2020
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)