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| Name | Class |
|---|---|
| Central Japan Lung Study Group | UNKNOWN |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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%.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab+Pemetrexed | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Human PD-1 Monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival | Up to approximately 3 years |
| 1 year progression free survival rate | 1 year progression free survival rate |
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Inclusion Criteria:
Exclusion Criteria:
Before the first dose of trial treatment:
Had major surgery (<3 weeks prior to the first dose)
Received radiation therapy to the lung that exceeds 30 Gy within 6 months of the first dose of the study treatment.
Completed palliative radiotherapy within 7 days of the first dose of the treatment.
Has received a live-virus vaccination within 30 days of planned treatment initiation.
Seasonal flu vaccines that do not contain live virus are permitted.
Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, peritoneal carcinomatosis.
Has a history of malignancy except if the subject has undergone curative therapy without recurrence for 5 years since initiation of that therapy.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Previously had a severe hypersensitivity reaction to treatment with another mAb.
Has a known sensitivity to any component of pemetrexed
Has active autoimmune disease that has required systemic treatment in past 2 years
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.
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin.
Is unable or unwilling to take folic acid or vitamin B12 supplementation.
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.
Has an active infection requiring therapy.
Has a history of Human Immunodeficiency Virus (HIV)
Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result.
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.
Has symptomatic ascites or pleural effusion.
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Patients wishing their partner to become pregnant during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihito Kogure, MD, PhD | National Hospital Organization Nagoya Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40007549 | Derived | Kogure Y, Hashimoto H, Daga H, Fukuda Y, Bessho A, Yamada T, Toi Y, Kimura T, Yoshioka H, Azuma K, Furuya N, Fukui Y, Saito AM, Yamamoto N, Saka H, Kondo M. Pembrolizumab and Pemetrexed for Older Patients With Nonsquamous NSCLC and Programmed Cell Death-Ligand 1 Tumor Proportion Scores of Less Than 50. JTO Clin Res Rep. 2024 Dec 24;6(3):100784. doi: 10.1016/j.jtocrr.2024.100784. eCollection 2025 Mar. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 4, 2024 | |
| Reset | Oct 25, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2024 | Oct 25, 2024 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Pemetrexed | Drug | Antineoplastic antimetabolite |
|
|
| 1 year |
| Overall survival | Overall survival | Up to approximately 3 years |
| Adverse event | Adverse event | Up to approximately 3 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |