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Non-squamous Non-small-cell Lung CancerPhase 2NCT04396457

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

A Phase 2 study testing Pembrolizumab and Pemetrexed in people with Non-squamous Non-small-cell Lung Cancer and Cancer, Lung, run by National Hospital Organization Nagoya Medical Center at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Pembrolizumab and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteJapan
Study dates
25 May 2020to Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

Other trials in Japan

About this study

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

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%.

Read the 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.

Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called KEYTRUDA Injection

    Human PD-1 Monoclonal antibody

  • PemetrexedDrug

    Also called Alimta Injection

    Antineoplastic antimetabolite

Study groups in NCT04396457
Study groupRoleWhat they receive
Pembrolizumab+PemetrexedExperimental200 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.
Receives: Drug: Pembrolizumab; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Overall response rate

    Measured: Up to approximately 3 years

Secondary outcomes (4)

  1. Progression free survival

    Progression free survival

    Measured: Up to approximately 3 years

  2. 1 year progression free survival rate

    1 year progression free survival rate

    Measured: 1 year

  3. Overall survival

    Overall survival

    Measured: Up to approximately 3 years

  4. Adverse event

    Adverse event

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start25 May 2020
  3. Primary completionMay 2023 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396457
Sponsor's protocol ID
NMC-CJLSG1901
Status last verified
Mar 2023
First submitted
14 Jan 2020
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kogure Y, Hashimoto H, Ikeda S, Harada T, Hino A, Miura S, Goto Y, Fujiwara K, Katakami N, Kubota K, Murata N, Mori M, Abe T, Saito AM, Yamamoto N, Saka H, Kondo M. Efficacy of pembrolizumab plus pemetrexed in older patients with non-squamous NSCLC according to PD-L1 expression status: Results from the CJLSG1901 study. Cancer Treat Res Commun. 2026;46:101094. doi: 10.1016/j.ctarc.2026.101094. Epub 2026 Jan 2.

    PubMed 41581413

  • 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.

    PubMed 40007549

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Pemetrexed in people with Non-squamous Non-small-cell Lung Cancer and Cancer, Lung, run by National Hospital Organization Nagoya Medical Center at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396457, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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