Lung AdenocarcinomaPhase 2NCT05528458
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
A Phase 2 study testing Osimertinib 80Mg Tab in people with Lung Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Osimertinib 80Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2022to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
- Male subjects should be willing to use barrier contraception during the study and for 4 months after last dose of osimertinib
Who cannot join
- 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:
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- 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;
- Aspartate aminotransferase >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases;
- Total bilirubin >1.5 times ULN if no liver metastases or >3 times ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinaemia] or liver metastases;
- Serum creatinine >1.5 times ULN concurrent with creatinine clearance <50 mL/min [measured or calculated by Cockcroft and Gault equation]-confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.
- Women who are breast-feeding
- Males and females of reproductive potential who are not using and effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site).
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Sehoon Lee
Seoul, 06351
Sehoon Lee, PhD, 82-2-3410-1529, sehoon.lee@samsung.com
About this study
Official title: A Phase II Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) for Actionable EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
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.
Read the detailed description
GGN (Ground-glass opacity nodule) is defined as rounded areas of homogeneous or heterogeneous increased attenuation in computed tomography (CT) scans, which are lower in density with regard to surrounding soft tissue structures, such as vessels, that is generally associated with the early-stage lung adenocarcinoma (Lee et al 2011). Therefore, some insist that the malignancy-favored GGO should be called GGN. Multiple pure GGO lesions detected in patients undergoing pulmonary resection for lung adenocarcinoma have a high possibility of malignancy if the size is greater than 7.5 mm. (Kim et al 2009) Nowadays, GGNs of the lung are increasingly detected with thin-section CT scan. GGNs are categorized as pure GGNs and mixed GGNs according to the images from a high-resolution CT.
Usually, lung adenocarcinoma with synchronous GGNs is considered a distinct disease entity in multiple synchronous lung cancers. Few studies have performed next-generation sequencing analysis of these synchronous sequential lesions. Recent study shows that multiple synchronous lesions in the same patient showed different mutation profiles (Park et al 2018) That suggests that adenocarcinoma and synchronous GGNs are genetically independent tumor. But interestingly, driver gene mutations were homogeneously distributed. These findings support the relevance of molecular characterization of lung adenocarcinoma and accompanying GGNs.
The development of a standardized approach to the interpretation and management of GGNs remain critically important given that peripheral adenocarcinomas represent the most common type of lung cancer, with evidence of increasing frequency.
The surgical management of patients with remaining GGN(s) who underwent surgery for the main tumor is still controversial. Although surgical approaches for the remaining lesions depend on their anatomical location, size, and number, as well as the patient's age and pulmonary function, the decision usually depends on the surgeon's judgment; no standard criteria have been established for the selection of the lesions to be treated, nor the method of management of the residual nodules in cases of resectable lung adenocarcinoma with synchronous GGNs. If GGNs are located deep in the hilum or scattered in different lobes or contralateral lung, they cannot be resected simultaneously so that may require additional surgery or radiation therapy. Investiators hypothesized that, in patients with confirmed EGFR mutation positive disease, postoperative osimertinib may regress synchronous GGNs, and eventually, avoid the need of repeated surgery. The purpose of this study is to confirm the efficacy and safety of osimertinib to regress synchronous GGNs in other lobes by osimertinib for stage IB-IIIA adenocarcinoma after curative resection.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Osimertinib 80Mg Tab
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osimertinib 80Mg TabDrug
Also called Tagrisso
Subjects have a osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Osimertinib 80Mg Tab |
| Obsevation | No intervention | Subjects with confirmation of pathologic stage IA NSCLC after surgery will be allocated to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start11 Sep 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528458
- Sponsor's protocol ID
- 2022-05-063
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) for Actionable EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05528458
- Acronym / sponsor ID
- 2022-05-063
- Conditions
- Lung Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GGN (Ground-glass opacity nodule) is defined as rounded areas of homogeneous or heterogeneous increased attenuation in computed tomography (CT) scans, which are lower in density with regard to surrounding soft tissue structures, such as vessels, that is generally associated with the early-stage lung adenocarcinoma (Lee et al 2011). Therefore, some insist that the malignancy-favored GGO should be called GGN. Multiple pure GGO lesions detected in patients undergoing pulmonary resection for lung adenocarcinoma have a high possibility of malignancy if the size is greater than 7.5 mm. (Kim et al 2009) Nowadays, GGNs of the lung are increasingly detected with thin-section CT scan. GGNs are categorized as pure GGNs and mixed GGNs according to the images from a high-resolution CT.
Usually, lung adenocarcinoma with synchronous GGNs is considered a distinct disease entity in multiple synchronous lung cancers. Few studies have performed next-generation sequencing analysis of these synchronous sequential lesions. Recent study shows that multiple synchronous lesions in the same patient showed different mutation profiles (Park et al 2018) That suggests that adenocarcinoma and synchronous GGNs are genetically independent tumor. But interestingly, driver gene mutations were homogeneously distributed. These findings support the relevance of molecular characterization of lung adenocarcinoma and accompanying GGNs.
The development of a standardized approach to the interpretation and management of GGNs remain critically important given that peripheral adenocarcinomas represent the most common type of lung cancer, with evidence of increasing frequency.
The surgical management of patients with remaining GGN(s) who underwent surgery for the main tumor is still controversial. Although surgical approaches for the remaining lesions depend on their anatomical location, size, and number, as well as the patient's age and pulmonary function, the decision usually depends on the surgeon's judgment; no standard criteria have been established for the selection of the lesions to be treated, nor the method of management of the residual nodules in cases of resectable lung adenocarcinoma with synchronous GGNs. If GGNs are located deep in the hilum or scattered in different lobes or contralateral lung, they cannot be resected simultaneously so that may require additional surgery or radiation therapy. Investiators hypothesized that, in patients with confirmed EGFR mutation positive disease, postoperative osimertinib may regress synchronous GGNs, and eventually, avoid the need of repeated surgery. The purpose of this study is to confirm the efficacy and safety of osimertinib to regress synchronous GGNs in other lobes by osimertinib for stage IB-IIIA adenocarcinoma after curative resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osimertinib | Experimental | Drug: Osimertinib 80Mg TabSubjects 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. |
| Obsevation | No intervention | –Subjects with confirmation of pathologic stage IA NSCLC after surgery will be allocated to the control group. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osimertinib 80Mg TabAlso: TagrissoSubjects have a osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection | Drug | Osimertinib |
Primary outcome
To assess the efficacy of osimertinib on the regression of additional GGN(s)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib 80Mg Tab in people with Lung Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sehoon Lee, PhD (82-2-3410-1529, sehoon.lee119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of osimertinib on the regression of additional GGN(s) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.