A Pilot Study of NK Cell Combined With PD-1 Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03958097|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Combination Product: NK cell and PD-1 antibody||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of NK Cell Combined With PD-1 Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung Cancer|
|Estimated Study Start Date :||May 17, 2019|
|Estimated Primary Completion Date :||May 16, 2020|
|Estimated Study Completion Date :||May 16, 2020|
Experimental: NK cell combined with PD-L1 antibody
Autologous peripheral blood mononuclear cells (PBMCs) are collected by apheresis on D0, then induced into NK cells and infused into the patients 14 days later (D14) as the initial transfusion. There are 3 consecutive transfusion days (D14-D16), total NK cells infused at least 3×10^9 .
200mg PD-L1 antibody(Sintilimab Injection) will be given on D14, 1 hour after NK cells infusion.
NK cells and PD-L1 antibody will be infused every 21 days until disease progression or unacceptable adverse events.
Combination Product: NK cell and PD-1 antibody
Each patient enrolled the study will received both NK cell and PD-1 antibody.
- Progression Free Survival(PFS) [ Time Frame: 12 months ]From the random date until the date when the objective disease progression (evaluated by the investigator according to RECIST 1.1) or for any reason (whichever occurs first) is confirmed, based on the ITT set.
- Overall Response Rate(ORR) [ Time Frame: 12 months ]The proportion of patients with CR or PR (evaluated by the investigator according to RECIST 1.1), based on the ITT set.
- Overall Survival(OS) [ Time Frame: 12 months ]The time from the random date to the date of death for any reason, based on the ITT population.
- Duration of Response(DoR) [ Time Frame: 12 months ]The time from the first confirmed objective remission to recurrence (evaluated by the investigator according to RECIST 1.1) or for any reason, whichever occurs first.
- Disease Control Rate(DCR) [ Time Frame: 12 months ]The proportion of patients with the best overall response to CR, PR, or disease stabilization (SD) (according to RECIST V1.1 evaluation).
- Clinical Benefit Rate(CBR) [ Time Frame: 12 months ]The proportion of patients who have achieved CR, PR, or SD for > 24 weeks (according to RECIST 1.1).
- Prognostic biomarkers [ Time Frame: 12 months ]PD-L1 expression on tumor, TMB, PD-L1 expression on NK cell, serum IL-8, serum LDH.
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): NCT03958097
|Contact: Jiuwei Cui, M.D. Ph.D.||firstname.lastname@example.org|
|First Hospital of Jilin University||Recruiting|
|Chang chun, Jilin, China, 130013|
|Contact: jiuwei Cui, M.D. Ph.D 043188783173 email@example.com|