Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02845856

Enrollment

Registered

2016-07-27

Start date

2016-07-01

Completion date

2019-07-01

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Non-small Cell Lung Cancer

Keywords

recurrent lung cancer, EGFR mutation, Cetuximab, NK immunotherapy

Brief summary

The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.

Detailed description

By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Cetuximab and NK cells. The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Interventions

DRUGCetuximab

400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations

BIOLOGICALNK immunotherapy

For each procedure, 10 billion cells will be infused in 4 times

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence * Body tumor 1-6, the maximum tumor length \< 5 cm * KPS ≥ 70, lifespan \> 6 months * Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion criteria

* Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Design outcomes

Primary

Measure	Time frame	Description
Relief degree evaluated by RECIST	3 months	It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary

Measure	Time frame
Progress free survival (PFS)	1 year
Overall survival (OS)	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026