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

STATUS

Recruiting
participants needed

50
sponsor

National Hospital Organization Nagoya Medical Center

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Updated on 19 February 2024

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cancer

measurable disease

metastasis

pembrolizumab

lung cancer

pemetrexed

immunomodulators

recurrent non-small cell lung cancer

squamous non-small cell lung carcinoma

adjuvant therapy

squamous non-small cell lung cancer

non-squamous non-small cell lung cancer

recurrent nsclc

adjuvant

non-small cell lung cancer

EGFR

small cell lung cancer

chromosomal translocation

Summary

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.

Details

Condition	Lung Neoplasm, lung cancer, lung cancer, Non-squamous Non-small-cell Lung Cancer
Age	75years - 100years
Treatment	Pembrolizumab, Pemetrexed
Clinical Study Identifier	NCT04396457
Sponsor	National Hospital Organization Nagoya Medical Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology
	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
	PD-L1 TPS of less than 50% with 22C3 antibody
	With at least one measurable lesion based on RECIST 1.1
	Age of 75 years or older on the day of informed consent
	ECOG Performance Status 0-1
	Without activating mutation in EGFR or ALK chromosomal translocation
	Absence of severe impairments of major organs
	Life expectancy of 12 weeks or more from the treatment start date
	Prior to the study registration, able to provide written informed consent after a thorough explanation of the study content
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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Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901