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

Phase 2

• Conditions: EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
• Interventions: Drug: Icotinib combined dihydroaremisinin

• Registration Number: NCT03402464
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18
• Primary Completion: 2019-06-01
• Study Completion: 2020-09-20

Recruitment & Eligibility

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

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib combined dihydroaremisinin	Icotinib combined dihydroaremisinin	-

Primary Outcome Measures

Name	Time	Method
Progress Free Survival	18 months
Objective response rate	18 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival	24 months

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China