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

NCT03254004 | Unknown Phase 2

• 1 other identifier: 2017-08-032
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Adenocarcinoma, Stage I

Outcome Measures

Primary Outcomes (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

  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)

Study Arms (1)

single arm: pembrolizumab

EXPERIMENTAL

pembrolizumab 200 mg every 3 weeks

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

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

single arm: pembrolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical centre

Seoul, Kangnam, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 40524802 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• jhingook Kim, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jhingook Kim, MD

CONTACT

82-10-9933-3483; jhingookkim@gmail.com

hyunjung Shin

CONTACT

82-2-3410-6763; hjds.shin@samsung.com

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: Professor

Model Details: Pembrolizumab 200mg injection

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: October 8, 2018
• Primary Completion: March 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

KR (1)