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

NCT ID: NCT03402464

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2020-09-20

Brief 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.

Conditions

EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib combined dihydroaremisinin

Group Type: EXPERIMENTAL

Icotinib combined dihydroaremisinin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Ziping Wang

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziping Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, , China

Countries

China

Central Contacts

Ziping Wang, MD

Role: CONTACT

wangzp2007@126.com

86-10-88121122

Facility Contacts

Ziping Wang, MD

Role: primary

wangzp2007@126.com

86-10-88121122

Other Identifiers

BD-IC-IV88

Identifier Type: -

Identifier Source: org_study_id