Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

NCT05528458 | Recruiting Phase 2 DMC

• 1 other identifier: 2022-05-063
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, phase II study to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage IB-IIIA lung adenocarcinoma.

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of osimertinib on the regression of additional GGN(s)

  Regression rate of each individual GGN using investigator assessments by comparing the size of GGN(s) on the initial CT scan (at screening) to that in the last follow-up scan, assessed by a blinded independent central review (BICR) of the radiologic examination of each patient; We will conduct the quantitative analysis of GGNs on the initial and follow-up CT scans via VOI (Volume of Interest) segmentation. The findings of each GGN on the initial and follow-up CT scans will be analyzed as follows: (1) diameter of the GGO component, (2) diameter of the solid component, (3) volume, (4) mass, (5) density, and (6) a histogram of CT attenuation. Regression is defined as follows: (1) disappearance of GGN, 2) more than 25% decrease in longest diameter and no increase of mean density or 3) documented evidence of 25% decrease in kurtosis, skewness, mean density or mass in case of less than 25% decrease in longest diameter

  The imaging modalities used for GGN assessments will be CT scan (1 mm thin-section) of chest. Baseline, 12weeks, 24weeks, 36weeks, 52weeks and then every 24weeks until 5years assessments should be performed

Study Arms (2)

Osimertinib

EXPERIMENTAL

Subjects should continue on study treatment until objective disease progression, or for three years since osimertinib administration. If progression of remaining GGN on serial CT scan, patients will receive proper treatment for progressed GGN.

Drug: Osimertinib 80Mg Tab

Obsevation

NO INTERVENTION

Subjects with confirmation of pathologic stage IA NSCLC after surgery will be allocated to the control group.

Interventions

Osimertinib 80Mg Tab DRUG

Subjects have a osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection

Also known as: Tagrisso

Osimertinib

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Adult male or female patients, aged from 30 to 75 years
• Pathologic proven lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity with well-defined margin, mean density above -500 HU and greater than 7.5 mm in its maximum diameter
• The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.
• WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
• Complete surgical resection of the primary NSCLC is mandatory.
• Uneventful recovery from curative-intent lung cancer surgery
• For assignment in the control arm, subjects should be classified post-operatively as Stage IA on the basis of pathologic criteria (the 8th edition of TNM staging system for lung cancer).
• For assignment in the treatment arm, subjects should fulfil the following criteria in addition to the above criteria.
• Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic cirteria (the 8th edition of TNM staging system for lung cancer)
• Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing 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 LH and FSH levels in the post-menopausal range for the institution
• Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
• Further information in Appendix E (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods)

You may not qualify if:

• Regression of synchronous GGN after adjuvant chemotherapy prior to osimertinib
• Past history of postoperative ALI/ARDS or pneumonia during recovery period
• Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 week prior) (Appendix C). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value. Whenever QTc, is mentioned in this document, this refers to correction e made by Fridericia formula (QTcF),
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.
• Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/plasma potassium \< lower limit of normal (LLN); Serum/plasma magnesium \< LLN; Serum/plasma calcium \< LLN) , 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
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
• Inadequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values:
• Absolute neutrophil count \<1.5 x 109/L;
• Platelet count \<100 x 109/L;
• Haemoglobin \<90 g/L;
• Alanine aminotransferase \>2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases;

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Sehoon Lee

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Central Study Contacts

Sehoon Lee, PhD

CONTACT

82-2-3410-1529; sehoon.lee119@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: September 11, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

KR (1)