Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC

EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma Clinical Trial

Official title:

Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03402464
• Other study ID #: BD-IC-IV88
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 11, 2018
• Last updated: January 11, 2018
• Start date: January 2018
• Est. completion date: September 20, 2020

Study information

• Verified date: January 2018
• Source: Beijing Cancer Hospital
• Contact: Ziping Wang, MD
• Phone: 86-10-88121122
• Email: wangzp2007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 20, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy

2. Male or female patients aged =18 years, life expectancy = 12 weeks

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

4. Sensitive EGFR gene mutation(19/21)

5. Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)

2. Female subjects should not be pregnant or breast-feeding

3. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

4. Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)

5. Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
• Lung Neoplasms

Intervention

Drug:
• Icotinib combined dihydroaremisinin
Icotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival		18 months
Primary	Objective response rate		18 months
Secondary	Overall Survival		24 months