Effect of NK Cell Immunotherapy on Advanced Lung Adenocarcinoma Adenocarcinoma With EGFR Mutation

Shenzhen Fifth People's Hospital

Status and phase: Unknown; Early Phase 1

Conditions: NK Cell Mediated Immunity

Treatments: Biological: NK cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03662477

Shenzhen Fifth Hospita

Details and patient eligibility

About

This study was attempted to investigate the efficiency of NK cells immunotherapy on non-small cell lung cancer with and without EGFR mutation, and evaluated response rate (RR) and the progression-free survival (PFS).

Full description

Investigators will enrolle 100 patients who met the enrollment criteria. 50 patients were clinically confirmed EGFR mutation positive. They were divided into two groups (group A and group C according to if accepted NK therapy) in accordance with the principles of randomized. The rest 50 patients which were EGFR mutation negative were also divided into two groups (group B and group D) in accordance with the principles of randomized to be paired respectively with group A and group C. Comparison of lymphocyte number, serum tumor related biomarkers, circulating Tumor Cell (CTC), KPS and survival curves was carried out before after NK cell immunotherapy. The safety and short-term effects were evaluated followed by the median PDA, response rate assessment.

Enrollment: 10 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The criteriaof the enrollment are as following: (1) expected survival>6 months; (2) age between35-75 years old; (3) KPS >45; (4) platelets>80 × 109/L, WBC>3 × 109/L, hemoglobin>90g/L, prothrombin time-international normalized ratio (0.8-1.5), adequate hepatic function (bilirubin < 20 μM, aminotransferase<60 U/L) and renal function (serum creatinine < 130 μM, serum urea <10 mM); (5) All patients confirmed by pathology and/or imaging;

Exclusion criteria

The absence of level 3 hypertension, severe coronary disease, myelosuppression, respiratory disease, acute or chronic infection, and autoimmune diseases. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 4 patient groups

EGFR+NK+

Experimental group

Description:

The EGFR mutation positive patients were with the principles of randomized and NK cells treatment.

Treatment:

Biological: NK cells

EGFR+NK-

No Intervention group

Description:

The EGFR mutation positive patients were with the principles of randomized and without NK cells treatment .

EGFR-NK+

Experimental group

Description:

The EGFR mutation negative patients were with the principles of randomized and NK cells treatment .

Treatment:

Biological: NK cells

EGFR-NK-

No Intervention group

Description:

The EGFR mutation negative patients were with the principles of randomized and without NK cells treatment.