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%

JRCT ID: jRCTs041200012

Registered date:25/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-squamous non-small cell lung cancer
• Date of first enrollment: 25/05/2020
• Target sample size: 49
• Study type: Interventional

Intervention(s)

200 mg of Pembro is intravenously infused over 30 minutes and more on day 1.
500 mg/m2 of PEM 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 PEM and conducted in accordance with the daily dose at each institution.
And repeat the administration every 3 weeks as one cycle until the treatment cessation criteria are met. Upper limit of the Pembro administration is 35 cycles, and the PEM administration will continue until the treatment cessation criteria are met.

Outcome(s)

• Primary Outcome: Overall response rate

Secondary Outcome

Progression free survival
One year progression free survival rate
Overall survival
Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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)Is expecting to conceive or father children within the projected duration of the study.

Related Information

• Primary Sponsor: Kogure Yoshihito
• Source(s) of Monetary Support: MSD Co., Ltd.
• Secondary ID(s): NCT04396457