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Lung Adenocarcinoma, Stage IPhase 2NCT03254004

Postoperative Pembrolizumab for the Patients Who Have Solid Predominant or Micropapillary Lung Adenocarcinoma With Pathologic Stage I and Primary Tumor Than 4 cm

A Phase 2 study testing Pembrolizumab in people with Lung Adenocarcinoma, Stage I, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Pembrolizumab 200 mg every 3 weeks Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Lung Adenocarcinoma, Stage I
What is being tested?
Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSouth Korea
Study dates
8 Oct 2018to 30 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary lung adenocarcinoma patients with stage I and less than 4 centimeter of primary tumor, whose tumor should be solid-predominant or micropapillary (>5%) by postsurgical pathological examination.
  • Note: The specific methods and principles of pathology results follow the WHO's pathology guidelines. The institution uses diagnostic pathology results from the institution.
  • Note: Adenocarcinoma, solid-predominant subtype; This variant shows a major component of polygonal tumor cells forming sheets that lack recognizable patterns of adenocarcinoma, i.e., acinar, papillary, micropapillary, or lepidic growth. If the tumor is 100% solid, intracellular mucin should be present in >5 tumor cells in each of two high-power fields, and confirmed with histochemical stains for mucin.
  • Note: Adenocarcinoma, micropapillary subtype; This variant has, as a major component, tumor cells growing in papillary tufts forming florets that lack fibrovascular cores. These may appear detached from and/or connected to alveolar walls. The tumor cells are usually small and cuboidal, with variable nuclear atypia. Ring-like glandular structures may float within alveolar spaces. Vascular and stromal invasion is common. Psammoma bodies may be seen.
  • Be willing and able to provide written informed consent/assent for the trial.
  • No evidence of disease (NED) after surgical resection on baseline tumor imaging (chest CT, covering up to both adrenals). The following conditions are satisfied with the condition of the complete ablation(R0):
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  • free resection margins proved microscopically
  • no evidence of nodal metastasis by ststematic and radical nodal dissection
  • Be 20 years of age on day of signing informed consent.
  • Be willing to provide tissue from surgical specimen or excisional biopsy of a tumor lesion.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
  • Table 1 Adequate Organ Function Laboratory Values
  • Hematological
  • Absolute neutrophil count (ANC): ≥1,500 /mcL
  • Platelets: ≥100,000 / mcL
  • Hemoglobin: ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
  • Renal
  • Serum creatinine OR Measured or calculateda creatinine: ≤ 1.5 X upper limit of normal (ULN) OR
  • clearance(GFR can also be used in place of creatinine or CrCl): ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
  • Hepatic
  • Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
  • AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
  • Albumin: >2.5 mg/dL
  • Coagulation
  • International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intenede use of anticoagulants
  • Activated Partial Thromboplastin Time (aPTT): ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intenede use of anticoagulants
  • Creatinine clearance should be calculated per institutional standard.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Is on chronic systemic steroids. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
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  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live vaccine within 30 days of planned start of study therapy.
  • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Trial locations and contacts

1 site in 1 country.

jhingook Kim, MD contact

82-10-9933-3483

jhingookkim@gmail.com

hyunjung Shin contact

82-2-3410-6763

hjds.shin@samsung.com

South Korea1 site, 1 recruiting

  • Samsung medical centre

    Seoul, Kangnam

    jingook Kim, PhD

    Recruiting

Other trials in South Korea

About this study

A single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Pembrolizumab 200 mg every 3 weeks

Read the detailed description

This is a single center, open-label, single arm study in patients who have solid or micropapillary adenocarcinoma with pathologic stage I and primary tumor no more than 4 cm. Patients will be treated with pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.

Being tested
Pembrolizumab
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.

  • PembrolizumabDrug

    pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.

Study groups in NCT03254004
Study groupRoleWhat they receive
single arm: pembrolizumabExperimentalpembrolizumab 200 mg every 3 weeks
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the improvement of disease-free survival rate by adjuvant therapy with pembrolizumab for solid or micropapillary adenocarcinoma with pathologic stage I and tumor size no more than 4 cm.

    RECIST V1.1

    Measured: up to 16 times. (screening, every 4 cycles during the study, every 3 months till 1 year since the study treatment, and then every 4 months afterward till 2 years and thereafter every 6 months till 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2017
  2. Study start8 Oct 2018
  3. Primary completion30 Mar 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Pembrolizumab 200mg injection
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03254004
Sponsor's protocol ID
2017-08-032
Status last verified
Dec 2020
First submitted
16 Aug 2017
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kim J, Bang YH, Park S, Jung HA, Sun JM, Ahn JS, Ahn MJ, Jeon YJ, Lee J, Cho JH, Kim HK, Choi YS, Zo JI, Shim YM, Kang JH, Lee J, Choi YL, Han J, Hwang S, Lee HY, Lee SH. Adjuvant pembrolizumab therapy for completely resected stage I lung adenocarcinoma with micropapillary or solid histological subtypes: a single-center, single-arm, phase 2 trial. EClinicalMedicine. 2025 Jun 4;84:103282. doi: 10.1016/j.eclinm.2025.103282. eCollection 2025 Jun.

    PubMed 40524802

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Lung Adenocarcinoma, Stage I, 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 33 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 14 Dec 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact jhingook Kim, MD (82-10-9933-3483, jhingookkim@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 improvement of disease-free survival rate by adjuvant therapy with pembrolizumab for solid or micropapillary adenocarcinoma with pathologic stage I and tumor size no more than 4 cm. (time frame: up to 16 times. (screening, every 4 cycles during the study, every 3 months till 1 year since the study treatment, and then every 4 months afterward till 2 years and thereafter every 6 months till 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254004, which also lists 1 linked publication.

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 14 Dec 2020.

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