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

NCT04396457 | Unknown Phase 2 DMC

• 1 other identifier: NMC-CJLSG1901
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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%.

Conditions

Non-squamous Non-small-cell Lung Cancer; Cancer, Lung

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate

  Up to approximately 3 years

Secondary Outcomes (4)

• Progression free survival

  Up to approximately 3 years

• 1 year progression free survival rate

  1 year

• Overall survival

  Up to approximately 3 years

• Adverse event

  Up to approximately 3 years

Study Arms (1)

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.

Drug: Pembrolizumab; Drug: Pemetrexed

Interventions

Pembrolizumab DRUG

Human PD-1 Monoclonal antibody

Also known as: KEYTRUDA Injection

Pembrolizumab+Pemetrexed

Pemetrexed DRUG

Antineoplastic antimetabolite

Also known as: Alimta Injection

Pembrolizumab+Pemetrexed

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hospital Organization Nagoya Medical Center: lead
• Central Japan Lung Study Group: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Related Publications (1)

• 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.

  PMID: 40007549 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

pembrolizumab; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Yoshihito Kogure, MD, PhD

  National Hospital Organization Nagoya Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: May 20, 2020
• Study Start: May 25, 2020
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)