Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04396457|
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-squamous Non-small-cell Lung Cancer Cancer, Lung||Drug: Pembrolizumab Drug: Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 25, 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||October 2023|
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.
Human PD-1 Monoclonal antibody
Other Name: KEYTRUDA Injection
Other Name: Alimta Injection
- Overall response rate [ Time Frame: Up to approximately 3 years ]
- Progression free survival [ Time Frame: Up to approximately 3 years ]
- 1 year progression free survival rate [ Time Frame: 1 year ]
- Overall survival [ Time Frame: Up to approximately 3 years ]
- Adverse event [ Time Frame: Up to approximately 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396457
|Contact: Yoshihito Kogure, MD, PhDemail@example.com|
|Contact: Akane Saitofirstname.lastname@example.org|
|National Hospital Organization Nagoya Medical Center||Recruiting|
|Nagoya, Aichi, Japan, 460-0001|
|Contact: Yoshihito Kogure, MD,PhD +81-52-951-1111 email@example.com|
|Principal Investigator:||Yoshihito Kogure, MD, PhD||National Hospital Organization Nagoya Medical Center|