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Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396457
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Central Japan Lung Study Group
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
National Hospital Organization Nagoya Medical Center

Brief Summary:
To evaluate the efficacy and safety of Pembrolizumab + Pemetrexed in elderly patients with non-squamous non-small cell lung cancer with Programmed cell death (PD) -ligand1 (L1) tumor proportion score (TPS) of less than 50%.

Condition or disease Intervention/treatment Phase
Non-squamous Non-small-cell Lung Cancer Cancer, Lung Drug: Pembrolizumab Drug: Pemetrexed Phase 2

Detailed Description:
To evaluate the efficacy and safety of Pembrolizumab + Pemetrexed in elderly patients with non-squamous non-small cell lung cancer with Programmed cell death (PD) -ligand1 (L1) tumor proportion score (TPS) of less than 50%.Primary endpoint is overall response rate and secondary endpoints are progression free survival (PFS), 1 year PFS rate, overall survival and adverse event.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-squamous Non-small Cell Lung Cancer With PD-L1 Tumor Proportion Score of Less Than 50%: CJLSG1901
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab+Pemetrexed

200 mg of pembrolizumab is intravenously infused over 30 minutes and more on day 1.

500 mg/m^2 of pemetrexed is intravenously infused over 10 minutes and more on day 1.

*Administration of folic acid and vitamin B12 is started 1 week before the start of treatment with pemetrexed.

And repeat the administration every 3 weeks as one cycle until the treatment cessation criteria are met. Upper limit of the pembrolizumab administration is 35 cycles, and the pemetrexed administration will continue until the treatment cessation criteria are met.

Drug: Pembrolizumab
Human PD-1 Monoclonal antibody
Other Name: KEYTRUDA Injection

Drug: Pemetrexed
Antineoplastic antimetabolite
Other Name: Alimta Injection




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to approximately 3 years ]
  2. 1 year progression free survival rate [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: Up to approximately 3 years ]
  4. Adverse event [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology.
  2. Not received prior systemic treatment with stage IV, or recurrent NSCLC. Subjects who received adjuvant therapy are eligible if the adjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
  3. PD-L1 TPS of less than 50% with 22C3 antibody.
  4. With at least one measurable lesion based on RECIST 1.1.
  5. Age of 75 years or older on the day of informed consent.
  6. ECOG Performance Status 0-1.
  7. Without activating mutation in EGFR or ALK chromosomal translocation.
  8. Absence of severe impairments of major organs.
  9. Life expectancy of 12 weeks or more from the treatment start date.
  10. Prior to the study registration, able to provide written informed consent after a thorough explanation of the study content.

Exclusion Criteria:

  1. Before the first dose of trial treatment:

    Had major surgery (<3 weeks prior to the first dose)

  2. Received radiation therapy to the lung that exceeds 30 Gy within 6 months of the first dose of the study treatment.
  3. Completed palliative radiotherapy within 7 days of the first dose of the treatment.
  4. Has received a live-virus vaccination within 30 days of planned treatment initiation.

    Seasonal flu vaccines that do not contain live virus are permitted.

  5. Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, peritoneal carcinomatosis.
  6. Has a history of malignancy except if the subject has undergone curative therapy without recurrence for 5 years since initiation of that therapy.
  7. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  8. Previously had a severe hypersensitivity reaction to treatment with another mAb.
  9. Has a known sensitivity to any component of pemetrexed
  10. Has active autoimmune disease that has required systemic treatment in past 2 years
  11. 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.
  12. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin.
  13. Is unable or unwilling to take folic acid or vitamin B12 supplementation.
  14. Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms.
  15. Has an active infection requiring therapy.
  16. Has a history of Human Immunodeficiency Virus (HIV)
  17. Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result.
  18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the Principal Investigator.
  19. Has symptomatic ascites or pleural effusion.
  20. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  21. Patients wishing their partner to become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396457


Contacts
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Contact: Yoshihito Kogure, MD, PhD +81-52-951-1111 yo-kogure@umin.ac.jp
Contact: Akane Saito +81-52-951-1111 study.office@nnh.go.jp

Locations
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Japan
National Hospital Organization Nagoya Medical Center Recruiting
Nagoya, Aichi, Japan, 460-0001
Contact: Yoshihito Kogure, MD,PhD    +81-52-951-1111    yo-kogure@umin.ac.jp   
Sponsors and Collaborators
National Hospital Organization Nagoya Medical Center
Central Japan Lung Study Group
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Yoshihito Kogure, MD, PhD National Hospital Organization Nagoya Medical Center
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Responsible Party: National Hospital Organization Nagoya Medical Center
ClinicalTrials.gov Identifier: NCT04396457    
Other Study ID Numbers: NMC-CJLSG1901
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors