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

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

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%.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-squamous Non-small-cell Lung Cancer; Cancer, Lung
• Intervention / Treatment: Drug: Pembrolizumab; Drug: Pemetrexed

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: KEYTRUDA Injection; Drug: Pemetrexed; Antineoplastic antimetabolite; Other Names: Alimta Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Overall response rate	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	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	1 year
Overall survival	Overall survival	Up to approximately 3 years
Adverse event	Adverse event	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: National Hospital Organization Nagoya Medical Center
• Collaborators: Merck Sharp & Dohme LLC; Central Japan Lung Study Group
• Investigators: Principal Investigator: Yoshihito Kogure, MD, PhD, National Hospital Organization Nagoya Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Folic Acid Antagonists; Pembrolizumab; Pemetrexed
• Other Study ID Numbers: NMC-CJLSG1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No