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

Phase 1

Completed

• Conditions: Recurrent Non-small Cell Lung Cancer
• Interventions: Drug: Cetuximab; Biological: NK immunotherapy

• Registration Number: NCT02845856
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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).

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Primary Completion: 2017-07-01
• Status Verified: 2018-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cetuximab and NK immunotherapy	NK immunotherapy	In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Cetuximab and NK immunotherapy	Cetuximab	In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Cetuximab	Cetuximab	In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progress free survival (PFS)	1 year
Overall survival (OS)	3 years

Trial Locations

Locations (1)

Fuda cancer institute in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China