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Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX

Pembrolizumab for Metastatic Non-small Cell Lung Cancer (NSCLC) Patients Expressing PD-L1 Who Have Their Own Patient-derived Xenograft (PDX): Comparative Study of Clinical Response and In-vivo Antitumor Response Using Their Humanized CD34 PDX (Hu-CD34 PDX)

NCT03134456•Samsung Medical Center

View on ClinicalTrials.gov

Summary

This is a single center, open-label, single arm study in patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination chemotherapy. Patients will be treated with Pembrolizumab according to the dosage and administration in Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose. The patient should have their-own patient-derived xenograft (PDX) before enrollment of the study. The PDX will be used to set up their humanized CD34 PDX (Hu-CD34 PDX).

Detailed Description

Part A: Clinical trial (single arm study) in patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination chemotherapy. Part B: PDX experiment using Hu-CD34 PDX model in specific population selected from Part A (Clinical trial part) - responder and non-responder. In-vivo experiment using Hu-CD34 PDX will be done for about seven subjects, and thirty-two (32) Hu-CD34 PDX mice will be established from single patient to see in-vivo response. This research using PDX (Part B) will be conducted sequentially on clinical trial part in selected-population based on clinical response of Pembrolizumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be willing and able to provide written informed consent/assent for the trial.
•2. Have metastatic non-small cell lung cancer, which should be proven histologically.
•3. Disease progression on or after platinum-based chemotherapy. Patients with sensitive EGFR mutations should have disease progression on at least one of EGFR TKIs (including but not limited to gefitinib, erlotinib, afatinib, osimertinib). Patients with ALK fusion should have disease progression on at least one of ALK TKI (including but not limited to crizotinib or ceritinib).
•a. Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease are excluded (TKIs are not included in the number of regimens)
•4. Have tumor which express PD-L1(TPS ≥ 1%) confirmed by immunohistochemistry.
•5. Have their-own patient-derived xenograft established.
•6. Over 18 years of age on day of signing informed consent.
•7. Have measurable disease based on RECIST 1.1.
•8. Have a performance status of 0 to 1 on the ECOG Performance Scale.
•9. Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
+3 more criteria

Exclusion Criteria

•1. 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.
•2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•3. Hypersensitivity to pembrolizumab or any of its excipients.
•4. 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.
•5. 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.
•6. 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.
•7. Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
•8. 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.
•9. Has known history of, or any evidence of active, non-infectious pneumonitis.
•10. Evidence of interstitial lung disease.
+8 more criteria

Locations (1)

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

May 14, 2018

Primary Completion Date

July 8, 2019

Completion Date

July 13, 2023

Last Updated

December 3, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Non-Small Cell Lung Carcinoma

Interventions

Pembrolizumab Injection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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